An interventional study of Cortical Lamina Technique and Natural Healing (Control) in Tooth Extraction, Periapical Infections and Tooth Fracture, sponsored by ARDEC Academy. Completed at 1 site in Cuba. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-19.
Sponsored by ARDEC Academy · Not applicable, Interventional, and Treatment
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.
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).
37 studies on the registry are indexed under Tooth Fractures; 9 are open to participants now.
This study's enrollment of 40 is close to the median of 40 across 33 interventional studies indexed under Tooth Fractures.
Browse Tooth Fractures studies →ARDEC Academy is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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)
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.
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.
Change in Alveolar Ridge Width and Height
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.
Time frame: Baseline (immediately post-extraction) to 6 months after extraction
Volumetric Change of the Alveolar Ridge
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.
Time frame: Baseline to 6 months post-extraction
Plan to share: No — 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.
Ran from Apr 2024 to primary completion in Dec 2024, 8 months.
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