The study, with the ASTRA TECH Implant System, is comparing short implants (OsseoSpeed™) to standard length implants (OsseoSpeed™) in combination with bone grafting. The hypothesis is that the use of short implants in posterior maxilla with inadequate bone is as safe and predictable as placing standard length implants in combination with bone augmentation.
This study was designed as an open, prospective, randomized, controlled, multicenter, 5-year follow-up investigation evaluating the outcome of treatment with the OsseoSpeed™ implant 6 mm placed in the posterior maxilla compared to treatment with OsseoSpeed™ implant 11, 13 or 15 mm placed after bone grafting. The study was during the conduct of the study amended to include a 10-year extension cohort.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
101
ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm)
ASTRA TECH Implant System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm) in combination with bone grafting
Department of Oral Rehabilitation, Skeletal Development and Biomaterials, University of Connecticut, School of Dental Medicine
Farmington, Connecticut, United States
Ärztegesellschaft für Zahn- Mund- und Kieferheilkunde, Akademie für Orale Implantologie: Fürhauser, Haas, Mailath-Pokorny & Watzek OG
Vienna, Austria
Aesthetic Dent
Szczecin, Poland
Facultad de Medicina y Odontologia, Universidade de Santiago de Compostela
Implant Survival Rate
Any implant that is removed after implant placement will be considered a failure, whatever the reason for removal. Implant survival will be evaluated clinically and radiographically by counting the number of remaining implants. Implant survival rate will be calculated by dividing the number of non-failures by the number of installed implant.
Time frame: 5 years after permanent restoration
Average Marginal Bone Level (MBL) Change From Permanent Restoration on Implant Level
Marginal bone level will be determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimetres at the 5 year follow-up visit will be compared to values obtained at delivery of permanent restoration. Positive value denotes gain of bone. Negative value denotes loss of bone.
Time frame: Time of permanent restoration and 5 years after permanent restoration
Average Marginal Bone Level (MBL) Change From Permanent Restoration on Implant Level
Marginal bone level will be determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimetres at the 10 year follow-up visit will be compared to values obtained for the 10-years cohort at delivery of permanent restoration. Positive value denotes gain of bone. Negative value denotes loss of bone.
Time frame: Time of permanent restoration and 10 years after permanent restoration
Condition of Periimplant Mucosa Measured Through Bleeding on Probing (BoP)
Bleeding on Probing will be evaluated at four aspects per implant, i.e. mesially, distally, buccally and palatinally by using a periodontal probe. BoP will be recorded as presence or absence (Yes or No) of bleeding when probing to the bottom of the pocket. The proportion of surfaces that show presence of bleeding will be calculated and presented on a subject level.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Santiago de Compostela, Spain
Zentrum für Zahn-, Mund- und Kieferheilkunde der Universität Zürich
Zurich, Switzerland
Time frame: 5 years after permanent restoration
Condition of Periimplant Mucosa Measured Through Bleeding on Probing (BoP)
Bleeding on Probing will be evaluated at four aspects per implant, i.e. mesially, distally, buccally and palatinally by using a periodontal probe. BoP will be recorded as presence or absence (Yes or No) of bleeding when probing to the bottom of the pocket. The proportion of surfaces that show presence of bleeding will be calculated and presented on a subject level for the 10-years extension cohort.
Time frame: 10 years after permanent restoration
Condition of Periimplant Mucosa Measure by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration
PPD will be measured as the distance from the mucosal margin to the bottom of the probeable pocket in mm. A mean value will be calculated for each implant as well as for each subject. PPD changes in millimetres at the 5 year follow-up visit will be compared to values obtained at delivery of permanent restoration. Negative value denotes deeper pocket depth.
Time frame: Time of permanent restoration and 5 years after permanent restoration
Condition of Periimplant Mucosa Measure by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration
PPD will be measured as the distance from the mucosal margin to the bottom of the probeable pocket in mm. A mean value will be calculated for each implant as well as for each subject. PPD changes in millimetres at the 10 year follow-up visit will be compared to values obtained at delivery of permanent restoration. Negative value denotes deeper pocket depth.
Time frame: Time of permanent restoration and 10 years after permanent restoration
Change in Overall Oral Health Impact Profile (OHIP-49)
OHIP-49 is describing the consequences of different oral diseases and conditions. It contains 49 items (questions) divided into 7 domains which are; functional limitation, pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. OHIP-49 attempts to measure both the frequency and severity of oral problems on functional and psychosocial well-being. Responses are based on a Likert response, with scale range; 0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, 4 = very often, for each of the 49 questions with a higher score being related to a worse outcome. To facilitate assessment of perceived severity of impacts, each statement has a weight derived using the Thurstone's paired comparison technique to reflect the relative importance of each statement. The overall OHIP-49 include all 49 questions with a total minimum score of 0 and a maximum total score of 196, with a higher score being related to a worse outcome.
Time frame: At baseline (Visit 1 - screening and pre-surgical planning visit) and 5 years after permanent restoration
Change in Overall Oral Health Impact Profile (OHIP-49)
OHIP-49 is describing the consequences of different oral diseases and conditions. It contains 49 items (questions) divided into 7 domains which are; functional limitation, pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. OHIP-49 attempts to measure both the frequency and severity of oral problems on functional and psychosocial well-being. Responses are based on a Likert response, with scale range; 0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, 4 = very often, for each of the 49 questions with a higher score being related to a worse outcome. To facilitate assessment of perceived severity of impacts, each statement has a weight derived using the Thurstone's paired comparison technique to reflect the relative importance of each statement. The overall OHIP-49 include all 49 questions with a total minimum score of 0 and a maximum total score of 196, with a higher score being related to a worse outcome.
Time frame: At baseline (Visit 1 - screening and pre-surgical planning visit) and 10 years after permanent restoration