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

NCT07766057 | Completed

• 1 other identifier: DI-03_24/REG UNAB
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  2 months

Secondary Outcomes (1)

• Implant stability measured by Implant Stability Test value

  2 months

Study Arms (1)

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.

Procedure: Alveolar Ridge preservation and early implant placement

Interventions

Alveolar Ridge preservation and early implant placement PROCEDURE

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.

Alveolar Ridge Preservation Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Franco Cavalla: lead

Study Sites (1)

UNAB School of Dentistry

Santiago, RM, 7591538, Chile

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 14, 2026
• Study Start: July 1, 2024
• Primary Completion: July 1, 2026
• Study Completion: July 9, 2026
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)