Hopeless Tooth, Periapical Infections, Periodontal Disease, AVDC Stage 4, Tooth Extraction, Tooth Fracture
Conditions
Keywords
ridge preservation, Cortical Lamina, Bone Regeneration, Alveolar Bone Loss, Tooth extraction, Implant Site Development, Buccal Bone
Brief 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).
Interventions
PROCEDURECortical 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.
PROCEDURENatural 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.
Sponsors
ARDEC Academy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants and surgeons will know group allocation; however, the radiographic examiner assessing outcomes will remain blinded to reduce bias.
Intervention model description
Participants will be randomly assigned to one of two parallel groups. In the test group, a cortical lamina will be placed between the elevated mucoperiosteal flap and the buccal bone plate immediately after tooth extraction. In the control group, extraction sockets will heal spontaneously without lamina placement. Both groups will be followed for six months before implant placement to assess dimensional changes in the alveolar ridge.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Alveolar Ridge Width and Height | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volumetric Change of the Alveolar Ridge | 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. |
Countries
Cuba
Outcome results
None listed