Cortical Lamina for Alveolar Ridge Preservation

ARDEC Academy

Status: Completed

Conditions: Tooth Extraction; Periodontal Disease, AVDC Stage 4; Periapical Infections; Tooth Fracture; Hopeless Tooth

Treatments: Procedure: Cortical Lamina Technique; Procedure: Natural Healing (Control)

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT07231874

2024/01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Presence of a tooth indicated for extraction (maxillary incisors, canines, or premolars in either jaw).
• Age ≥ 21 years.
• Good general health with no contraindications for oral surgery.
• Non-pregnant individuals.
• Willingness to participate and sign written informed consent.

Exclusion criteria

• Uncontrolled systemic disease (e.g., diabetes mellitus, hypertension).
• History of chemotherapy or radiotherapy.
• Current smokers of more than 10 cigarettes per day.
• Sites previously treated with regenerative or augmentation procedures.
• Poor oral hygiene or active periodontal infection.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Test Group - Cortical Lamina Placement

Experimental group

Description:

Following atraumatic tooth extraction, a small full-thickness flap will be elevated without releasing incisions. A cortical lamina will be placed between the buccal bone plate and the elevated flap to isolate the periosteum and stabilize the ridge contour. The flap will then be repositioned and sutured for non-submerged healing. Sutures will be removed after two weeks. Standard postoperative care will include 0.12% chlorhexidine mouth rinses and analgesics as needed.

Treatment:

Procedure: Cortical Lamina Technique

Control Group - Spontaneous Healing

Active Comparator group

Description:

After tooth extraction, the site will be allowed to heal naturally without the placement of cortical lamina or any grafting material. The flap will be repositioned and sutured for non-submerged healing. Postoperative care will follow the same protocol as the test group.

Treatment:

Procedure: Natural Healing (Control)