Alveolar Ridge Preservation With Cortico-cancellous Porcine Bone
- Conditions
- Alveolar Ridge PreservationImplant TherapyTooth Extraction Site Healing
- Registration Number
- NCT06970184
- Lead Sponsor
- University of Pisa
- Brief Summary
Observational, prospective study conducted on patients requiring tooth extractions followed by ARP and subsequent implant placement.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 22
- 18 yo
- Needing tooth extraction followed by ARP and implant-prosthetic rehabilitation
- uncontrolled systemic diseases
- uncontrolled periodontitis
- undergoing previous or actual treatment with medications/radiations potentially impairing hard and soft tissues healing
- women during pregnancy or breastfeeding
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Histomorphometric characteristics of the bone: residual graft particles (RP) T1= 4 months following tooth extraction + ARP The primary outcome is evaluated in terms of Percentages of marrow spaces (MS) in the histological samples
Histomorphometric characteristics of the bone: Newly formed bone (NB) T1= 4 months following tooth extraction + ARP The primary outcome is evaluated in terms of Percentages of newly formed bone (NB) in the in the histological samples.
Histomorphometric characteristics of the bone: marrow spaces (MS) T1= 4 months following tooth extraction + ARP The primary outcome is evaluated in terms of Percentages of marrow spaces (MS) in the histological samples
- Secondary Outcome Measures
Name Time Method Marginal Bone Level T3= 1-year follow-up 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.
Horizontal alveolar measure T1= 4 months following tooth extraction + ARP Maximum alveolar crest width at implant placement (measured in millimeters) evaluated with a UNC periodontal probe
Vertical alveolar measure T1= 4 months following tooth extraction + ARP Mean distance (measured in millimeters) between mesial and distal reference points and the alveolar crest measured with a UNC periodontal probe
Aesthetic outcomes T3= 1-year follow-up 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
Trial Locations
- Locations (1)
U.O. Odontostomatologia e Chirurgia del Cavo Orale
🇮🇹Pisa, Italy