Skip to content

Early Dental Implant Installation in Regeneration Sites: a Prof of Concept Prospective Case Study

Early Dental Implant Installation in Regeneration Sites: a Prof of Concept Prospective Case Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07766057
Enrollment
10
Registered
2026-08-14
Start date
2024-07-01
Completion date
2026-07-09
Last updated
2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss

Keywords

Alveolar ridge preservation Dental implants Implant site preparation Bone regeneration

Brief 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. 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. 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.

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.

Interventions

PROCEDUREAlveolar Ridge preservation and early implant placement

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.

Sponsors

Franco Cavalla
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Histomorphometric percentage of newly formed bone2 monthsPercentage 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.

Secondary

MeasureTime frameDescription
Implant stability measured by Implant Stability Test value2 monthsImplant 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.

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 15, 2026