Cortical Lamina for Alveolar Ridge Preservation

NCT07231874 | Completed

• 1 other identifier: 2024/01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

ridge preservation; Cortical Lamina; Bone Regeneration; Alveolar Bone Loss; Tooth extraction; Implant Site Development; Buccal Bone

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (immediately post-extraction) to 6 months after extraction

Secondary Outcomes (1)

• Volumetric Change of the Alveolar Ridge

  Baseline to 6 months post-extraction

Study Arms (2)

Test Group - Cortical Lamina Placement

EXPERIMENTAL

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

Control Group - Spontaneous Healing

ACTIVE COMPARATOR

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)

Interventions

Cortical Lamina Technique PROCEDURE

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.

Test Group - Cortical Lamina Placement

Natural Healing (Control) PROCEDURE

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.

Control Group - Spontaneous Healing

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ARDEC Academy: lead

Study Sites (1)

University of Medical Sciences of Havana

Havana, La Habana, 10400, Cuba

Location

Related Publications (6)

• Avila-Ortiz G, Chambrone L, Vignoletti F. Effect of alveolar ridge preservation interventions following tooth extraction: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:195-223. doi: 10.1111/jcpe.13057. Erratum In: J Clin Periodontol. 2020 Jan;47(1):129. doi: 10.1111/jcpe.13212.

  PMID: 30623987 RESULT

• Atieh MA, Alsabeeha NH, Payne AG, Duncan W, Faggion CM, Esposito M. Interventions for replacing missing teeth: alveolar ridge preservation techniques for dental implant site development. Cochrane Database Syst Rev. 2015 May 28;2015(5):CD010176. doi: 10.1002/14651858.CD010176.pub2.

  PMID: 26020735 RESULT

• Richardson CR, Mellonig JT, Brunsvold MA, McDonnell HT, Cochran DL. Clinical evaluation of Bio-Oss: a bovine-derived xenograft for the treatment of periodontal osseous defects in humans. J Clin Periodontol. 1999 Jul;26(7):421-8. doi: 10.1034/j.1600-051x.1999.260702.x.

  PMID: 10412845 RESULT

• Lee JH, Yi GS, Lee JW, Kim DJ. Physicochemical characterization of porcine bone-derived grafting material and comparison with bovine xenografts for dental applications. J Periodontal Implant Sci. 2017 Dec;47(6):388-401. doi: 10.5051/jpis.2017.47.6.388. Epub 2017 Dec 31.

  PMID: 29333325 RESULT

• Klinge B, Alberius P, Isaksson S, Jonsson J. Osseous response to implanted natural bone mineral and synthetic hydroxylapatite ceramic in the repair of experimental skull bone defects. J Oral Maxillofac Surg. 1992 Mar;50(3):241-9. doi: 10.1016/0278-2391(92)90320-y.

  PMID: 1311759 RESULT

• Al Qabbani A, Al Kawas S, A Razak NH, Al Bayatti SW, Enezei HH, Samsudin AR, Sheikh Ab Hamid S. Three-Dimensional Radiological Assessment of Alveolar Bone Volume Preservation Using Bovine Bone Xenograft. J Craniofac Surg. 2018 Mar;29(2):e203-e209. doi: 10.1097/SCS.0000000000004263.

  PMID: 29303859 RESULT

MeSH Terms

Conditions

Tooth Fractures; Periodontal Diseases; Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Tooth Injuries; Tooth Diseases; Stomatognathic Diseases; Wounds and Injuries; Mouth Diseases; Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and surgeons will know group allocation; however, the radiographic examiner assessing outcomes will remain blinded to reduce bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 17, 2025
• Study Start: April 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: October 1, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CU (1)