Cortical Lamina for Alveolar Ridge Preservation (Lamina)

November 16, 2025 updated by: ARDEC Academy

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cuba
    • La Habana
      • Havana, La Habana, Cuba, 10400
        • University of Medical Sciences of Havana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Group - Cortical Lamina Placement
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.
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.
Active Comparator: Control Group - Spontaneous Healing
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Alveolar Ridge Width and Height
Time Frame: Baseline (immediately post-extraction) to 6 months after extraction
Linear dimensional changes in the alveolar ridge (horizontal width and vertical height) will be evaluated using cone-beam computed tomography (CBCT) images taken immediately after tooth extraction (baseline) and six months post-surgery. Measurements will be made at standardized reference points on cross-sectional CBCT slices to quantify resorption or preservation of bone.
Baseline (immediately post-extraction) to 6 months after extraction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volumetric Change of the Alveolar Ridge
Time Frame: Baseline to 6 months post-extraction
Volumetric dimensional changes of the alveolar ridge will be assessed by comparing 3D digital models of the extraction sites obtained from intraoral impressions taken at baseline (immediately post-extraction) and six months after surgery. Superimposition and digital analysis will be performed to quantify total volume loss or preservation of the alveolar ridge contour.
Baseline to 6 months post-extraction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ARDEC Academy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

October 1, 2025

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Estimated)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 16, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared because the study is conducted at a single clinical center with a limited sample size, and the data contain identifiable clinical imaging and patient information. Aggregated results and summary analyses will be made available through scientific publications and conference presentations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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