Alveolar Ridge Preservation
Conditions
Brief summary
Dental implants are considered a predictable rehabilitative option following tooth extraction or in cases of missing teeth. In some situations, the inevitable alveolar ridge resorption that occurs after extraction may make the placement of standard-diameter (\>3.5 mm) or standard-length implants difficult or even impossible without advanced bone augmentation procedures. To counteract post-extraction volumetric bone contraction, alveolar ridge preservation can be performed, consisting of placing a bone graft within the socket walls immediately after tooth extraction. Although this procedure cannot completely prevent dimensional changes, it has been shown to significantly reduce both horizontal and vertical ridge resorption, as reported in the scientific literature. However, there is a lack of clinical and radiographic studies evaluating the outcomes of implant rehabilitation following alveolar ridge preservation with standard-dimension implants in a hospital-based setting.
Interventions
None listed
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients requiring alveolar ridge preservation procedures prior to implant rehabilitation of edentulous sites; * Age \> 18; * Achievement of FMPS and FMBS ≤ 15%; * Signed written informed consent to participate in the study.
Exclusion criteria
* Uncontrolled diabetes or hypertension; * Uncontrolled periodontal disease; * Inability to perform consistent and continuous follow-up; * Pregnancy or breastfeeding; * Inability to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volumetric analysis | From tooth extraction to 6 months of follow up. | The dimensional change of hard tissues following bone regenerative procedures will be assessed radiographically by measuring horizontal and vertical bone resorption through CBCT comparison in patients treated in a hospital-based setting. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Esthetic evaluation | From tooth extraction to 5 years of follow-up | Assessed using the PES/WES esthetic index. Scores range from 0 to 14 for the PES and from 0 to 10 for the WES, with higher scores indicating better esthetic outcomes. |
| Implant success rate | From tooth extraction to 5 years of follow up | Absence of biological and technical complications, expressed as a proportion |
| Implant survival rate | From tooth extraction to 5 years follow up | Rate of dental implants remaining in situ, measured as a proportion |
| Prosthesis success rate | From tooth extraction to 5 years of follow up | Absence of technical complications, expressed as a proportion |
| Prosthesis survival rate | From tooth extraction to 5 years of follow up | Rate of prostheses remaining in situ, expressed as a proportion |
| Patient-Reported Outcome Measures | From tooth extraction to 5 years of follow up | Recorded using a specifically designed questionnaire and measured with a visual analogue scale (VAS) ranging from 0 to 10, with higher scores indicating better outcomes |
| Diabetes | From tooth extraction to 5 years of follow up | Analysis of the influence of diabetes (assessed as presence/absence) as potential risk factor during follow-up |
| Glycated hemoglobin level | From tooth extraction to 5 years of follow up | Analysis of glycated hemoglobin levels recorded at baseline and during follow-up |
| Correlation of medications relevant to bone/soft tissue metabolism with implant health | From tooth extraction to 5 years of follow up | Correlation between exposure to medications affecting bone and soft tissue metabolism and peri-implant marginal bone loss (measured in millimeters on standardized periapical radiographs) and implant success (defined as the absence of complications). |
| Correlation between osteoporosis status and implant health | From tooth extraction to 5 years of follow up | Correlation between osteoporosis status (DXA T-score/ICD diagnosis) and peri-implant marginal bone loss (measured in millimeters on standardized periapical radiographs) and implant success (defined as the absence of complications). |
| Correlation between cardiovascular disease and implant health | From tooth extraction to 5 years of follow up | Correlation between cardiovascular diseases and peri-implant marginal bone loss (measured in millimeters on standardized periapical radiographs) and implant success (defined as the absence of complications). |
| Complete Blood Count | From tooth extraaction to 5 years of follow up | Analysis of the influence of complete blood count parameters |
| Histologic analysis | From tooth extraction to 6 months of follow up | Histomorphometric analysis of hard and soft tissues on stained histologic sections (% new bone, residual graft, epithelial thickness, keratin layer thickness, inflammatory infiltrate, collagen organization, and vascular density) |
Countries
Italy
Contacts
CONTACTCarlo Lajolo, MD, DDS
PRINCIPAL_INVESTIGATORCarlo Lajolo
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Outcome results
None listed