The purpose of this study is to evaluate the soft tissue clinical results in patients that received, or not, a soft tissue augmentation around dental implant inserted immediately after the extraction.
After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening period to determinate eligibility for study entry. Patients who meet eligibility requirements will be randomized in this single blinded(investigator) study. Group (Test) will receive immediate implant after extraction and a soft tissue augmentation with a collagen matrix. Group (Control) will receive only immediate implant after extraction without soft tissue augmentation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
After tooth extraction and implant insertion the Test group will receive a soft tissue augmentation on the buccal side oh the implant. an envelop flap will be raised and a volume-stable collagen graft will be stabilized with sutures. Control group will not receive soft tissue augmentation.
U.O. Odontostomatologia e Chirurgia del Cavo Orale
Pisa, Italy, Italy
Soft Tissue Thickness (STT)
Measured at 3 and 6 mm from the free gingival margin using a 15-endodontic file and a rubber disk. The file will advance perpendicularly through the soft tissue until the first point of bone contact. Thickness will be measured to the nearest 0.1 mm using a caliper. The rubber disk stop will be then placed in tight contact with the soft tissue surface and fixed with a drop of cyanocrylic adhesive. After file removal, the distance between file tip and the silicon stop will be measured using a digital caliper with 0.01 mm of accuracy. (Cairo et al. 2017; Bittner et al. 2020)
Time frame: T0a: baseline before surgery
Soft Tissue Thickness (STT)
Measured at 3 and 6 mm from the free gingival margin using a 15-endodontic file and a rubber disk. The file will advance perpendicularly through the soft tissue until the first point of bone contact. Thickness will be measured to the nearest 0.1 mm using a caliper. The rubber disk stop will be then placed in tight contact with the soft tissue surface and fixed with a drop of cyanocrylic adhesive. After file removal, the distance between file tip and the silicon stop will be measured using a digital caliper with 0.01 mm of accuracy. (Cairo et al. 2017; Bittner et al. 2020)
Time frame: T0b: baseline after surgery
Soft Tissue Thickness (STT)
Measured at 3 and 6 mm from the free gingival margin using a 15-endodontic file and a rubber disk. The file will advance perpendicularly through the soft tissue until the first point of bone contact. Thickness will be measured to the nearest 0.1 mm using a caliper. The rubber disk stop will be then placed in tight contact with the soft tissue surface and fixed with a drop of cyanocrylic adhesive. After file removal, the distance between file tip and the silicon stop will be measured using a digital caliper with 0.01 mm of accuracy. (Cairo et al. 2017; Bittner et al. 2020)
Time frame: T2: 12 months after implant placement
Vertical position of soft tissue (VPS)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
A tooth-supported Essix stent will be used to record the distance from three reference marks (mesial papilla, midbuccal margin, and distal papilla) to the free gingival margin using a color-coded probe (15mm, UNC). The same stent will be used for measurements at the different follow-up visits. (Bittner et al. 2020)
Time frame: T0a: baseline before surgery
Vertical position of soft tissue (VPS)
A tooth-supported Essix stent will be used to record the distance from three reference marks (mesial papilla, midbuccal margin, and distal papilla) to the free gingival margin using a color-coded probe (15mm, UNC). The same stent will be used for measurements at the different follow-up visits. (Bittner et al. 2020)
Time frame: T0b: baseline after surgery
Vertical position of soft tissue (VPS)
A tooth-supported Essix stent will be used to record the distance from three reference marks (mesial papilla, midbuccal margin, and distal papilla) to the free gingival margin using a color-coded probe (15mm, UNC). The same stent will be used for measurements at the different follow-up visits. (Bittner et al. 2020)
Time frame: T1: 2 weeks after crown delivery, 4 months from surgery
Vertical position of soft tissue (VPS)
A tooth-supported Essix stent will be used to record the distance from three reference marks (mesial papilla, midbuccal margin, and distal papilla) to the free gingival margin using a color-coded probe (15mm, UNC). The same stent will be used for measurements at the different follow-up visits. (Bittner et al. 2020)
Time frame: T2: 12 months after surgery
Vertical position of soft tissue (VPS)
A tooth-supported Essix stent will be used to record the distance from three reference marks (mesial papilla, midbuccal margin, and distal papilla) to the free gingival margin using a color-coded probe (15mm, UNC). The same stent will be used for measurements at the different follow-up visits. (Bittner et al. 2020)
Time frame: T3: 24 months after surgery
Vertical position of soft tissue (VPS)
A tooth-supported Essix stent will be used to record the distance from three reference marks (mesial papilla, midbuccal margin, and distal papilla) to the free gingival margin using a color-coded probe (15mm, UNC). The same stent will be used for measurements at the different follow-up visits. (Bittner et al. 2020)
Time frame: T4: 36 months after surgery
Assessment of the linear volumetric changes
Impressions of the grafted sites will be taken including at least the two neighboring teeth and using a silicone impression material. Dental stone casts will be fabricated and optically scanned with a desktop 3D scanner. Digital models of each time-point per patient will be captured as stereolithography (STL) files. The images of the baseline and follow-up datasets will be superimposed and matched using the best-fit algorithm at the adjacent tooth surfaces. After definition of specific regions of interest (ROI), the software will calculated the volumetric changes measured in mm, which will correspond to the mean distance between the three surfaces representing the evaluated time-points. One buccal ROI will be defined: a trapezoid shape area between the gingival margins of the adjacent teeth, the mucogingival junction as apical and the interproximal areas as lateral borders. The measured will be kept constant in each patient and site over time. (Zeltner 2017)
Time frame: T0a: baseline before surgery
Assessment of the linear volumetric changes
Impressions of the grafted sites will be taken including at least the two neighboring teeth and using a silicone impression material. Dental stone casts will be fabricated and optically scanned with a desktop 3D scanner. Digital models of each time-point per patient will be captured as stereolithography (STL) files. The images of the baseline and follow-up datasets will be superimposed and matched using the best-fit algorithm at the adjacent tooth surfaces. After definition of specific regions of interest (ROI), the software will calculated the volumetric changes measured in mm, which will correspond to the mean distance between the three surfaces representing the evaluated time-points. One buccal ROI will be defined: a trapezoid shape area between the gingival margins of the adjacent teeth, the mucogingival junction as apical and the interproximal areas as lateral borders. The measured will be kept constant in each patient and site over time. (Zeltner 2017)
Time frame: T1: 2 weeks after crown delivery, 4 months from surgery
Assessment of the linear volumetric changes
Impressions of the grafted sites will be taken including at least the two neighboring teeth and using a silicone impression material. Dental stone casts will be fabricated and optically scanned with a desktop 3D scanner. Digital models of each time-point per patient will be captured as stereolithography (STL) files. The images of the baseline and follow-up datasets will be superimposed and matched using the best-fit algorithm at the adjacent tooth surfaces. After definition of specific regions of interest (ROI), the software will calculated the volumetric changes measured in mm, which will correspond to the mean distance between the three surfaces representing the evaluated time-points. One buccal ROI will be defined: a trapezoid shape area between the gingival margins of the adjacent teeth, the mucogingival junction as apical and the interproximal areas as lateral borders. The measured will be kept constant in each patient and site over time. (Zeltner 2017)
Time frame: T2: 12 months after surgery
Assessment of the linear volumetric changes
Impressions of the grafted sites will be taken including at least the two neighboring teeth and using a silicone impression material. Dental stone casts will be fabricated and optically scanned with a desktop 3D scanner. Digital models of each time-point per patient will be captured as stereolithography (STL) files. The images of the baseline and follow-up datasets will be superimposed and matched using the best-fit algorithm at the adjacent tooth surfaces. After definition of specific regions of interest (ROI), the software will calculated the volumetric changes measured in mm, which will correspond to the mean distance between the three surfaces representing the evaluated time-points. One buccal ROI will be defined: a trapezoid shape area between the gingival margins of the adjacent teeth, the mucogingival junction as apical and the interproximal areas as lateral borders. The measured will be kept constant in each patient and site over time. (Zeltner 2017)
Time frame: T3: 24 months after surgery
Assessment of the linear volumetric changes
Impressions of the grafted sites will be taken including at least the two neighboring teeth and using a silicone impression material. Dental stone casts will be fabricated and optically scanned with a desktop 3D scanner. Digital models of each time-point per patient will be captured as stereolithography (STL) files. The images of the baseline and follow-up datasets will be superimposed and matched using the best-fit algorithm at the adjacent tooth surfaces. After definition of specific regions of interest (ROI), the software will calculated the volumetric changes measured in mm, which will correspond to the mean distance between the three surfaces representing the evaluated time-points. One buccal ROI will be defined: a trapezoid shape area between the gingival margins of the adjacent teeth, the mucogingival junction as apical and the interproximal areas as lateral borders. The measured will be kept constant in each patient and site over time. (Zeltner 2017)
Time frame: T4: 36 months after surgery
Pink Esthetic Score (PES)
PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft- tissue contour, alveolar process deficiency, soft-tissue colour and texture. Each variable will be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. The papillae values will be evaluated for completeness, incompleteness or absence. Other variables will be assessed by comparison with a reference tooth. The highest possible score reflecting a perfect match of the peri-implant soft tissue with that of the reference tooth will be 14. (Furhauser et al. 2005)
Time frame: T1: 2 weeks after crown delivery, 4 months from surgery
Pink Esthetic Score (PES)
PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft- tissue contour, alveolar process deficiency, soft-tissue colour and texture. Each variable will be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. The papillae values will be evaluated for completeness, incompleteness or absence. Other variables will be assessed by comparison with a reference tooth. The highest possible score reflecting a perfect match of the peri-implant soft tissue with that of the reference tooth will be 14. (Furhauser et al. 2005)
Time frame: T2: 12 months after surgery
Pink Esthetic Score (PES)
PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft- tissue contour, alveolar process deficiency, soft-tissue colour and texture. Each variable will be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. The papillae values will be evaluated for completeness, incompleteness or absence. Other variables will be assessed by comparison with a reference tooth. The highest possible score reflecting a perfect match of the peri-implant soft tissue with that of the reference tooth will be 14. (Furhauser et al. 2005)
Time frame: T3: 24 months after surgery
Pink Esthetic Score (PES)
PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft- tissue contour, alveolar process deficiency, soft-tissue colour and texture. Each variable will be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. The papillae values will be evaluated for completeness, incompleteness or absence. Other variables will be assessed by comparison with a reference tooth. The highest possible score reflecting a perfect match of the peri-implant soft tissue with that of the reference tooth will be 14. (Furhauser et al. 2005)
Time frame: T4: 36 months after surgery
Papillae index (PI)
The statuses of the mesial and distal papilla will be assessed using the Papillae index (from 0 to 3). (Jemt et al. 1997)
Time frame: T0a: baseline before surgery
Papillae index (PI)
The statuses of the mesial and distal papilla will be assessed using the Papillae index (from 0 to 3). (Jemt et al. 1997)
Time frame: T0b: baseline after surgery
Papillae index (PI)
The statuses of the mesial and distal papilla will be assessed using the Papillae index (from 0 to 3). (Jemt et al. 1997)
Time frame: T1: 2 weeks after crown delivery, 4 months from surgery
Papillae index (PI)
The statuses of the mesial and distal papilla will be assessed using the Papillae index (from 0 to 3). (Jemt et al. 1997)
Time frame: T2: 12 months after surgery
Papillae index (PI)
The statuses of the mesial and distal papilla will be assessed using the Papillae index (from 0 to 3). (Jemt et al. 1997)
Time frame: T3: 24 months after surgery
Papillae index (PI)
The statuses of the mesial and distal papilla will be assessed using the Papillae index (from 0 to 3). (Jemt et al. 1997)
Time frame: T4: 36 months after surgery
Width of keratinized tissue (WKT)
WKT will be measured, with a periodontal probe (mm), mid-facially from the gingival margin to the muco-gingival junction of the intended extracted tooth or the implant supported restoration.
Time frame: T0a: baseline before surgery
Width of keratinized tissue (WKT)
WKT will be measured, with a periodontal probe (mm), mid-facially from the gingival margin to the muco-gingival junction of the intended extracted tooth or the implant supported restoration.
Time frame: T1: 2 weeks after crown delivery, 4 months from surgery
Width of keratinized tissue (WKT)
WKT will be measured, with a periodontal probe (mm), mid-facially from the gingival margin to the muco-gingival junction of the intended extracted tooth or the implant supported restoration.
Time frame: T2: 12 months after surgery
Width of keratinized tissue (WKT)
WKT will be measured, with a periodontal probe (mm), mid-facially from the gingival margin to the muco-gingival junction of the intended extracted tooth or the implant supported restoration.
Time frame: T3: 24 months after surgery
Width of keratinized tissue (WKT)
WKT will be measured, with a periodontal probe (mm), mid-facially from the gingival margin to the muco-gingival junction of the intended extracted tooth or the implant supported restoration.
Time frame: T4: 36 months after surgery
Peri-implant marginal bone level (MBL)
MBL will be measured on intraoral radiographs at the mesial and distal aspects (m and d). It will be set as the distance between the reference point and the most apical point of contact between the implant surface and the bone. The reference point will be the fixture-abutment interface. Digital intraoral periapical radiographs will be taken using a parallel cone technique with digital sensor. A paralleling device and individualized bite blocks made of polyvinyl siloxane impression material will be used for the standardization of the X-ray geometry. Calibration will be performed using the known thread-pitch distance of the implants. Measurements will be taken to the nearest millimeter using computer software.
Time frame: T0b: baseline after surgery
Peri-implant marginal bone level (MBL)
MBL will be measured on intraoral radiographs at the mesial and distal aspects (m and d). It will be set as the distance between the reference point and the most apical point of contact between the implant surface and the bone. The reference point will be the fixture-abutment interface. Digital intraoral periapical radiographs will be taken using a parallel cone technique with digital sensor. A paralleling device and individualized bite blocks made of polyvinyl siloxane impression material will be used for the standardization of the X-ray geometry. Calibration will be performed using the known thread-pitch distance of the implants. Measurements will be taken to the nearest millimeter using computer software.
Time frame: T1: 2 weeks after crown delivery, 4 months from surgery
Peri-implant marginal bone level (MBL)
MBL will be measured on intraoral radiographs at the mesial and distal aspects (m and d). It will be set as the distance between the reference point and the most apical point of contact between the implant surface and the bone. The reference point will be the fixture-abutment interface. Digital intraoral periapical radiographs will be taken using a parallel cone technique with digital sensor. A paralleling device and individualized bite blocks made of polyvinyl siloxane impression material will be used for the standardization of the X-ray geometry. Calibration will be performed using the known thread-pitch distance of the implants. Measurements will be taken to the nearest millimeter using computer software.
Time frame: T2: 12 months after surgery
Peri-implant marginal bone level (MBL)
MBL will be measured on intraoral radiographs at the mesial and distal aspects (m and d). It will be set as the distance between the reference point and the most apical point of contact between the implant surface and the bone. The reference point will be the fixture-abutment interface. Digital intraoral periapical radiographs will be taken using a parallel cone technique with digital sensor. A paralleling device and individualized bite blocks made of polyvinyl siloxane impression material will be used for the standardization of the X-ray geometry. Calibration will be performed using the known thread-pitch distance of the implants. Measurements will be taken to the nearest millimeter using computer software.
Time frame: T3: 24 months after surgery
Peri-implant marginal bone level (MBL)
MBL will be measured on intraoral radiographs at the mesial and distal aspects (m and d). It will be set as the distance between the reference point and the most apical point of contact between the implant surface and the bone. The reference point will be the fixture-abutment interface. Digital intraoral periapical radiographs will be taken using a parallel cone technique with digital sensor. A paralleling device and individualized bite blocks made of polyvinyl siloxane impression material will be used for the standardization of the X-ray geometry. Calibration will be performed using the known thread-pitch distance of the implants. Measurements will be taken to the nearest millimeter using computer software.
Time frame: T4: 36 months after surgery
Phenotype
It will be based on the lack of transparency of a periodontal probe through the gingival margin when probing the buccal sulcus of the failing tooth (De Rouck et al. 2009).
Time frame: T0a: baseline before surgery
Phenotype
It will be based on the lack of transparency of a periodontal probe through the gingival margin when probing the buccal sulcus of the failing tooth (De Rouck et al. 2009).
Time frame: T1: 2 weeks after crown delivery, 4 months from surgery
Phenotype
It will be based on the lack of transparency of a periodontal probe through the gingival margin when probing the buccal sulcus of the failing tooth (De Rouck et al. 2009).
Time frame: T2: 12 months after surgery
Phenotype
It will be based on the lack of transparency of a periodontal probe through the gingival margin when probing the buccal sulcus of the failing tooth (De Rouck et al. 2009).
Time frame: T3: 24 months after surgery
Phenotype
It will be based on the lack of transparency of a periodontal probe through the gingival margin when probing the buccal sulcus of the failing tooth (De Rouck et al. 2009).
Time frame: T4: 36 months after surgery
Probing pocket depth (PD)
probing pocket depth using a manual periodontal probe at the mesio-buccal, mid-buccal, and disto-buccal and mid-palatal aspect. The distance measured from the base of the pocket to the most apical point on the gingival margin, expressed in millimeters (Mombelli et al., 1987).
Time frame: T0a: baseline before surgery
Probing pocket depth (PD)
probing pocket depth using a manual periodontal probe at the mesio-buccal, mid-buccal, and disto-buccal and mid-palatal aspect.The distance measured from the base of the pocket to the most apical point on the gingival margin, expressed in millimeters (Mombelli et al., 1987).
Time frame: T1: 2 weeks after crown delivery, 4 months from surgery
Probing pocket depth (PD)
probing pocket depth using a manual periodontal probe at the mesio-buccal, mid-buccal, and disto-buccal and mid-palatal aspect.The distance measured from the base of the pocket to the most apical point on the gingival margin, expressed in millimeters (Mombelli et al., 1987).
Time frame: T2: 12 months after surgery
Probing pocket depth (PD)
probing pocket depth using a manual periodontal probe at the mesio-buccal, mid-buccal, and disto-buccal and mid-palatal aspect.The distance measured from the base of the pocket to the most apical point on the gingival margin, expressed in millimeters (Mombelli et al., 1987).
Time frame: T3: 24 months after surgery
Probing pocket depth (PD)
probing pocket depth using a manual periodontal probe at the mesio-buccal, mid-buccal, and disto-buccal and mid-palatal aspect.The distance measured from the base of the pocket to the most apical point on the gingival margin, expressed in millimeters (Mombelli et al., 1987).
Time frame: T4: 36 months after surgery
Modified Plaque Index (mPI)
Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth. (Mombelli et al., 1987);
Time frame: T0a: baseline before surgery
Modified Plaque Index (mPI)
Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth. (Mombelli et al., 1987);
Time frame: T1: 2 weeks after crown delivery, 4 months from surgery
Modified Plaque Index (mPI)
Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth. (Mombelli et al., 1987);
Time frame: T2: 12 months after surgery
Modified Plaque Index (mPI)
Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth. (Mombelli et al., 1987);
Time frame: T3: 24 months after surgery
Modified Plaque Index (mPI)
Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth. (Mombelli et al., 1987);
Time frame: T4: 36 months after surgery
Gingival bleeding on probing (BoP)
Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding. (Mombelli et al., 1987).
Time frame: T0a: baseline before surgery
Gingival bleeding on probing (BoP)
Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding. (Mombelli et al., 1987).
Time frame: T1: 2 weeks after crown delivery, 4 months from surgery
Gingival bleeding on probing (BoP)
Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding. (Mombelli et al., 1987).
Time frame: T2: 12 months after surgery
Gingival bleeding on probing (BoP)
Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding. (Mombelli et al., 1987).
Time frame: T3: 24 months after surgery
Gingival bleeding on probing (BoP)
Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding. (Mombelli et al., 1987).
Time frame: T4: 36 months after surgery
Implant success
Implant failure and Implant success criteria will be recorded according to Buser et al.1990.
Time frame: T1: 2 weeks after crown delivery, 4 months from surgery
Implant success
Implant failure and Implant success criteria will be recorded according to Buser et al.1990.
Time frame: T2: 12 months after surgery
Implant success
Implant failure and Implant success criteria will be recorded according to Buser et al.1990.
Time frame: T3: 24 months after surgery
Implant success
Implant failure and Implant success criteria will be recorded according to Buser et al.1990.
Time frame: T4: 36 months after surgery
Biological and technical complication
Complications from biological and technical nature (Pjetursson et al. 2012).
Time frame: T0a: baseline before surgery
Biological and technical complication
Complications from biological and technical nature (Pjetursson et al. 2012).
Time frame: T0b: baseline after surgery
Biological and technical complication
Complications from biological and technical nature (Pjetursson et al. 2012).
Time frame: T1: 2 weeks after crown delivery, 4 months from surgery
Biological and technical complication
Complications from biological and technical nature (Pjetursson et al. 2012).
Time frame: T2: 12 months after surgery
Biological and technical complication
Complications from biological and technical nature (Pjetursson et al. 2012).
Time frame: T3: 24 months after surgery
Biological and technical complication
Complications from biological and technical nature (Pjetursson et al. 2012).
Time frame: T4: 36 months after surgery
Surgery time
The surgery time will be recorded in both groups to the closest minute from the start of the first incision to the accomplishment of the last suture.
Time frame: T0a-b: baseline
Patient satisfaction OHIP-14
The Oral Health Impact Profile (OHIP-14) is a questionnaire addressed the following domains: functional limitation, physical pain, psychological discomfort, physical disability, psycho- logical disability, social disability and handicap. These domains were evaluated by 2 questions each and scored by means of a 5-point Likert scale resulting in a total OHIP score ranging from 14 to 70 with higher scores being indicative of more discomfort in daily life. (Slade \& Spencer, 1994)
Time frame: T0a: baseline before surgery
Patient satisfaction OHIP-14
The Oral Health Impact Profile (OHIP-14) is a questionnaire addressed the following domains: functional limitation, physical pain, psychological discomfort, physical disability, psycho- logical disability, social disability and handicap. These domains were evaluated by 2 questions each and scored by means of a 5-point Likert scale resulting in a total OHIP score ranging from 14 to 70 with higher scores being indicative of more discomfort in daily life. (Slade \& Spencer, 1994)
Time frame: T1: 2 weeks after crown delivery, 4 months from surgery
Patient satisfaction OHIP-14
The Oral Health Impact Profile (OHIP-14) is a questionnaire addressed the following domains: functional limitation, physical pain, psychological discomfort, physical disability, psycho- logical disability, social disability and handicap. These domains were evaluated by 2 questions each and scored by means of a 5-point Likert scale resulting in a total OHIP score ranging from 14 to 70 with higher scores being indicative of more discomfort in daily life. (Slade \& Spencer, 1994)
Time frame: T2: 12 months after surgery
Patient satisfaction OHIP-14
The Oral Health Impact Profile (OHIP-14) is a questionnaire addressed the following domains: functional limitation, physical pain, psychological discomfort, physical disability, psycho- logical disability, social disability and handicap. These domains were evaluated by 2 questions each and scored by means of a 5-point Likert scale resulting in a total OHIP score ranging from 14 to 70 with higher scores being indicative of more discomfort in daily life. (Slade \& Spencer, 1994)
Time frame: T3: 24 months after surgery
Patient satisfaction OHIP-14
The Oral Health Impact Profile (OHIP-14) is a questionnaire addressed the following domains: functional limitation, physical pain, psychological discomfort, physical disability, psycho- logical disability, social disability and handicap. These domains were evaluated by 2 questions each and scored by means of a 5-point Likert scale resulting in a total OHIP score ranging from 14 to 70 with higher scores being indicative of more discomfort in daily life. (Slade \& Spencer, 1994)
Time frame: T4: 36 months after surgery
Patient satisfaction VAS
Patients were asked to respond to the following question on a Visual analogic scale: "How satisfied are you with the overall aesthetic result?" and "How satisfied are you with the overall functional result?"."Most unsatisfied" and "most satisfied" were indicated as extremes on the 100-mm lines.
Time frame: T0a: baseline before surgery
Patient satisfaction VAS
Patients were asked to respond to the following question on a Visual analogic scale: "How satisfied are you with the overall aesthetic result?" and "How satisfied are you with the overall functional result?"."Most unsatisfied" and "most satisfied" were indicated as extremes on the 100-mm lines.
Time frame: T1: 2 weeks after crown delivery, 4 months from surgery
Patient satisfaction VAS
Patients were asked to respond to the following question on a Visual analogic scale: "How satisfied are you with the overall aesthetic result?" and "How satisfied are you with the overall functional result?"."Most unsatisfied" and "most satisfied" were indicated as extremes on the 100-mm lines.
Time frame: T2: 12 months after surgery
Patient satisfaction VAS
Patients were asked to respond to the following question on a Visual analogic scale: "How satisfied are you with the overall aesthetic result?" and "How satisfied are you with the overall functional result?"."Most unsatisfied" and "most satisfied" were indicated as extremes on the 100-mm lines.
Time frame: T3: 24 months after surgery
Patient satisfaction VAS
Patients were asked to respond to the following question on a Visual analogic scale: "How satisfied are you with the overall aesthetic result?" and "How satisfied are you with the overall functional result?"."Most unsatisfied" and "most satisfied" were indicated as extremes on the 100-mm lines.
Time frame: T4: 36 months after surgery