Alveolar Ridge Preservation, Implant Therapy, Tooth Extraction Site Healing
Conditions
Keywords
ARP, tooth extraction, dental implants, porcine bone, collagen
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).
Interventions
PROCEDUREtooth extraction with alveolar ridge preservation
alveolar ridge preservation performed after tooth extraction
PROCEDUREImplant placement
Implant placement
Sponsors
University of Pisa
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 yo * Needing tooth extraction followed by ARP and implant-prosthetic rehabilitation
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Marginal Bone Level | T1= 4 months following tooth extraction + ARP | 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. |
| Aesthetic outcomes | T2= 3 months following implant placement | 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 |
| Horizontal alveolar measure | Day 1 = tooth extraction + ARP | Maximum post-extractive buccal/lingual distance (measured in millimeters) of the socket evaluated with a UNC periodontal probe |
| Vertical alveolar measure | Day 1 = tooth extraction + ARP | Mean distance (measured in millimeters) between mesial and distal reference points and the alveolar crest measured with a UNC periodontal probe |
Countries
Italy
Outcome results
None listed