NCT07231874

Cortical Lamina for Alveolar Ridge Preservation

Preservation of the Alveolar Ridge Using a Cortical Lamina After Tooth Extraction: A Randomized Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: ARDEC Academy · Network
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

This randomized controlled clinical trial aims to evaluate the efficacy of placing a cortical lamina between the elevated flap and buccal bone plate following tooth extraction for preserving alveolar ridge dimensions. Forty patients will be randomly assigned to either the test group (lamina placement) or control (no intervention). Changes in ridge width and height will be assessed using CBCT and 3D digital models after six months.

Detailed description

Alveolar bone resorption after tooth extraction can compromise prosthetic and implant rehabilitation by reducing both bone height and width, especially at the buccal plate. Various alveolar ridge preservation (ARP) techniques have been proposed to minimize these dimensional changes; however, their clinical predictability and long-term benefit remain debated. This randomized controlled clinical trial aims to evaluate the efficacy of placing a cortical lamina between the elevated mucoperiosteal flap and the buccal bone plate immediately after tooth extraction to preserve alveolar ridge dimensions. The technique is intended to limit post-extraction resorption by temporarily isolating the periosteum from the underlying bone, promoting favorable bone remodeling and contour maintenance for subsequent implant placement. Forty patients requiring the extraction of single teeth (premolars, canines, or maxillary incisors) will be enrolled and randomly allocated into two groups: Test group: A cortical lamina will be inserted between the buccal bone and the flap following tooth extraction. Control group: Extraction sites will be left untreated to heal spontaneously. All surgeries will be performed under local anesthesia by calibrated clinicians. Healing will occur by primary intention without submerged flaps. Sutures will be removed after two weeks. Patients will follow standardized postoperative care, including chlorhexidine rinses and analgesics as needed. Cone-beam computed tomography (CBCT) and digital impressions will be obtained at baseline (immediately post-extraction) and at six months. The primary outcome is the linear change in ridge width and height measured on CBCT scans. Secondary outcomes include volumetric dimensional changes analyzed from 3D digital impressions. Data will be analyzed using parametric or non-parametric tests depending on normal distribution (ANOVA or Kruskal-Wallis, with appropriate post-hoc comparisons). A significance level of p \< 0.05 will be applied. The study follows the Declaration of Helsinki and CONSORT 2010 guidelines. Ethical approval has been granted by the Comité de Ética de la Investigación, Universidad de Ciencias Médicas de La Habana (Aval 2024/01, April 9 2024).

Conditions

• Tooth Extraction
• Periapical Infections
• Tooth Fracture
• Periodontal Disease, AVDC Stage 4
• Hopeless Tooth

Interventions

Type	Name	Description
PROCEDURE	Cortical Lamina Technique	Surgical placement of a cortical lamina between the buccal bone plate and elevated mucoperiosteal flap immediately after tooth extraction. The lamina serves as a barrier to stabilize the alveolar contour and promote bone preservation. The flap is sutured for non-submerged healing, and postoperative care includes chlorhexidine rinses and analgesics as needed.
PROCEDURE	Natural Healing (Control)	After tooth extraction, the site will heal naturally without placement of cortical lamina or any grafting material. The flap is repositioned and sutured for non-submerged healing. Postoperative care is identical to the test group.

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-12-01
• Completion: 2025-10-01
• First posted: 2025-11-17
• Last updated: 2025-11-19

Locations

1 site across 1 country: Cuba