Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth LossNCT07766057
Early Dental Implant Installation in Regeneration Sites: a Prof of Concept Prospective Case Study
An observational study of Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, run by Franco Cavalla at 1 site in Chile.
Trial summary
This study will evaluate bone healing after tooth extraction and alveolar ridge preservation, a common procedure used to maintain the bone volume needed for future dental implant placement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss
- What is being tested?
- Alveolar Ridge preservation and early implant placement
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteChile
- Study dates
- 1 Jul 2024to 9 Jul 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include adult patients requiring tooth extraction followed by alveolar ridge preservation and delayed implant-supported rehabilitation as part of their routine dental treatment. Participants will be selected from patients treated in a clinical dental setting who present with extraction sites considered suitable for ridge preservation and subsequent implant placement based on clinical and radiographic evaluation. The population reflects patients commonly treated for post-extraction implant site development in routine practice.
Who may be able to join
- Adult patients requiring tooth extraction, alveolar ridge preservation, and subsequent implant-supported rehabilitation.
- Patients with an extraction site suitable for alveolar ridge preservation and delayed implant placement according to clinical and radiographic evaluation.
- Patients able and willing to attend follow-up visits and undergo implant placement after the healing period.
- Patients who provide written informed consent to participate in the study.
Who cannot join
- Patients with uncontrolled systemic conditions that may interfere with wound healing or bone regeneration.
- Patients with acute infection at the extraction site that, in the investigator's judgment, contraindicates alveolar ridge preservation.
- Patients requiring major additional bone augmentation procedures at the extraction site beyond the planned alveolar ridge preservation procedure.
- Pregnant or breastfeeding patients.
- Patients with a history of head and neck radiotherapy, current chemotherapy, or other conditions that may compromise bone healing.
- Patients unable to provide informed consent or comply with the study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate bone healing after tooth extraction and alveolar ridge preservation, a common procedure used to maintain the bone volume needed for future dental implant placement.
Participants will be adult patients who require tooth extraction, ridge preservation, and later implant-supported rehabilitation as part of their routine dental treatment. After the tooth is removed, the extraction socket will be treated with a bone graft material and covered with a membrane according to standard clinical procedures.
Read more
At the time of implant placement, a small cylindrical bone sample will be collected from the same site where the implant will be placed. This tissue would normally be removed during preparation of the implant site. Therefore, no additional surgical access or tissue removal will be performed solely for research purposes.
The collected samples will be analyzed under the microscope to evaluate the amount and characteristics of newly formed bone and remaining graft material. The study aims to better understand the quality of bone regeneration after alveolar ridge preservation and its suitability for implant placement.
Read the detailed description
Alveolar ridge preservation is commonly performed after tooth extraction to reduce post-extraction dimensional changes and support future implant placement. Although this procedure is widely used in clinical practice, the histologic characteristics of the regenerated tissue may vary depending on the biomaterial used, the healing period, and patient-related factors. Histomorphometric analysis of bone core biopsies obtained at the time of implant placement provides direct information about newly formed bone, residual graft particles, and non-mineralized tissue within the regenerated ridge.
This clinical study will be conducted in adult patients requiring tooth extraction, alveolar ridge preservation, and subsequent implant-supported rehabilitation as part of their routine dental treatment. After tooth extraction, the socket will be treated using a guided bone regeneration approach according to standard clinical procedures. The treated site will be allowed to heal before implant placement.
At the time of implant placement, a cylindrical bone core biopsy will be obtained during preparation of the implant osteotomy. The biopsy will be collected from tissue that would otherwise be removed as part of the standard implant site preparation. No additional surgical access or tissue removal will be performed exclusively for research purposes beyond collection of the trephine core from the planned implant osteotomy site.
The retrieved bone core specimens will be processed for histologic and histomorphometric evaluation. The analysis will assess the composition of the regenerated tissue, including newly formed bone, residual graft material, and non-mineralized connective tissue. These findings will help characterize the quality of bone healing after alveolar ridge preservation and provide information on the suitability of the regenerated site for implant-supported rehabilitation.
The study is designed to reflect routine clinical conditions and to evaluate biologic outcomes using tissue obtained during a standard step of implant therapy.
- Conditions
- Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss
- Being tested
- Alveolar Ridge preservation and early implant placement
- Keywords
- Alveolar ridge preservation Dental implants Implant site preparation Bone regeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar Ridge preservation and early implant placementProcedure or surgery
Alveolar ridge preservation will be performed immediately after tooth extraction using a guided bone regeneration approach. Following atraumatic extraction and socket debridement, the extraction socket will be filled with bone graft material and covered with a barrier membrane according to standard clinical procedures. The intervention is intended to preserve ridge volume and support subsequent implant placement. Implant placement will be performed after the healing period, and a trephine core biopsy will be obtained during preparation of the planned implant osteotomy site for histologic and histomorphometric analysis.
| Study group | Role | What they receive |
|---|---|---|
| Alveolar Ridge Preservation Cohort | Participants in this cohort are adult patients requiring tooth extraction, alveolar ridge preservation, and subsequent implant-supported rehabilitation as part of their routine dental treatment. After tooth extraction, the socket will be treated with a bone graft material and covered with a membrane according to standard clinical procedures. Following the healing period, implant placement will be performed. During implant site preparation, a trephine bone core biopsy will be collected from the planned implant osteotomy site, from tissue that would otherwise be removed as part of the standard procedure. The collected samples will be used for histologic and histomorphometric evaluation of regenerated tissue composition. Receives: Procedure: Alveolar Ridge preservation and early implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histomorphometric percentage of newly formed bone
Percentage of newly formed bone within the bone core biopsy obtained at implant placement. Histologic sections will be analyzed using histomorphometry, and newly formed bone will be expressed as a percentage of the total analyzed tissue area.
Measured: 2 months
Secondary outcomes (1)
Implant stability measured by Implant Stability Test value
Implant stability will be assessed at the time of implant placement using the AnyCheck device. The Implant Stability Test value will be recorded for each implant as an objective measure of primary implant stability at the regenerated site.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start1 Jul 2024
- Primary completion1 Jul 2026
- Study completion9 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Franco Cavalla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Franco Cavalla, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766057
- Sponsor's protocol ID
- DI-03_24/REG UNAB
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No