Observational, prospective study conducted on patients requiring tooth extractions followed by ARP and subsequent implant placement.
The primary aim of this study is to compare the histomorphometric characteristics of two different formulations of CCPB used for ARP, and the secondary aim is to evaluate and compare clinical and aesthetic outcomes of dental implants placed in augmented sites. Patients requiring the extraction of an hopeless tooth followed by ARP and subsequent implant placement are considered potentially eligible for the study. At T0, Tooth extractions are performed trying to reduce the surgical trauma as possible. ARP is performed with 2 different combinations of a cortico-cancellous porcine bone with a thermogel (50:50 ratio, hand-mixed or 80:20 ratio, pre-mixed). After 4 months of healing, patients undergo a radiographic examination before implant placement. A T1, Implant site preparation is carried out using a trephine bur (to remove a core biopsy of the bone) followed by conventional osteotomy drills, and bone-level implants are placed. Bone samples are analyzed to evaluate new bone formation, presence of residual graft particles and marrow spaces. Three months after placement, all implants are rehabilitated with screw-retained prosthetic crowns (T2). Follow up is scheduled 1 year after prosthetic loading (T3).
Study Type
OBSERVATIONAL
Enrollment
22
alveolar ridge preservation performed after tooth extraction
Implant placement
U.O. Odontostomatologia e Chirurgia del Cavo Orale
Pisa, Italy, Italy
Histomorphometric characteristics of the bone: Newly formed bone (NB)
The primary outcome is evaluated in terms of Percentages of newly formed bone (NB) in the in the histological samples.
Time frame: T1= 4 months following tooth extraction + ARP
Histomorphometric characteristics of the bone: marrow spaces (MS)
The primary outcome is evaluated in terms of Percentages of marrow spaces (MS) in the histological samples
Time frame: T1= 4 months following tooth extraction + ARP
Histomorphometric characteristics of the bone: residual graft particles (RP)
The primary outcome is evaluated in terms of Percentages of marrow spaces (MS) in the histological samples
Time frame: T1= 4 months following tooth extraction + ARP
Marginal Bone Level
Radiographic marginal bone level (measured in millimeters) taken at the mesial and distal aspect of the implant as the distance from the implant-abutment interface to the most apical bone-implant contact.
Time frame: T1= 4 months following tooth extraction + ARP
Marginal Bone Level
Radiographic marginal bone level (measured in millimeters) taken at the mesial and distal aspect of the implant as the distance from the implant-abutment interface to the most apical bone-implant contact.
Time frame: T2= 3 months following implant placement
Marginal Bone Level
Radiographic marginal bone level (measured in millimeters) taken at the mesial and distal aspect of the implant as the distance from the implant-abutment interface to the most apical bone-implant contact.
Time frame: T3= 1-year follow-up
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Horizontal alveolar measure
Maximum post-extractive buccal/lingual distance (measured in millimeters) of the socket evaluated with a UNC periodontal probe
Time frame: Day 1 = tooth extraction + ARP
Horizontal alveolar measure
Maximum alveolar crest width at implant placement (measured in millimeters) evaluated with a UNC periodontal probe
Time frame: T1= 4 months following tooth extraction + ARP
Vertical alveolar measure
Mean distance (measured in millimeters) between mesial and distal reference points and the alveolar crest measured with a UNC periodontal probe
Time frame: Day 1 = tooth extraction + ARP
Vertical alveolar measure
Mean distance (measured in millimeters) between mesial and distal reference points and the alveolar crest measured with a UNC periodontal probe
Time frame: T1= 4 months following tooth extraction + ARP
Aesthetic outcomes
evaluated with the Pink Esthetic Score (PES) according to seven variables: mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar ridge deficiency, soft tissue color, and soft tissue texture. Each variable could have a score ranging between 0 to 2; the total PES has a maximum level of 14
Time frame: T2= 3 months following implant placement
Aesthetic outcomes
evaluated with the Pink Esthetic Score (PES) according to seven variables: mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar ridge deficiency, soft tissue color, and soft tissue texture. Each variable could have a score ranging between 0 to 2; the total PES has a maximum level of 14
Time frame: T3= 1-year follow-up