Effect of Collagen Membrane on Ridge Preservation

Debora Dias30 enrolled

Overview

This study will evaluate whether adding a resorbable collagen membrane to an anorganic bone-collagen composite (ABCC) graft improves ridge preservation after tooth extraction. Ridge preservation is a procedure used to maintain the shape and volume of the jawbone following tooth removal, which is important for future dental implant placement. Participants will be randomly assigned to receive either ABCC alone or ABCC combined with a collagen membrane. Healing outcomes will be assessed after approximately 4 months using three-dimensional cone beam computed tomography (CBCT) scans. The primary outcome is the change in horizontal ridge dimension (width). Secondary outcomes include vertical and contour changes in ridge dimensions, changes in soft tissue contour assessed with digital scans, postoperative healing and complications (such as wound dehiscence, swelling, or infection), and patient-reported outcomes, including pain and satisfaction. In a subset of participants, bone healing will also be evaluated using laboratory and imaging analyses of bone samples obtained at the time of implant placement. The study will additionally assess whether the treatment allows implant placement in the ideal position without the need for further bone grafting.

This study is a clinical trial that evaluates two different approaches to preserve the jawbone after tooth extraction in areas where part of the bone is already missing. Preserving the bone is important to support future dental implants. Participants will be randomly assigned (like flipping a coin) to receive one of two treatments: a bone graft material alone, or the same bone graft combined with a protective collagen membrane placed over it. Tooth extraction and follow-up care will be performed in the same manner for all participants. After approximately 4 months of healing, participants will return for dental implant placement. During the healing period and at the time of implant placement, the research team will evaluate how well the bone and gums have healed. This will include three-dimensional CBCT scans, digital intraoral scans, and clinical measurements. In some participants, a small sample of bone will be collected at the time of implant placement to study bone healing. The study will compare how effectively each treatment maintains the shape and volume of the jawbone, the quality of soft tissue healing, the risk of complications, patient-reported outcomes (PROs), including comfort and satisfaction, and whether additional procedures are required prior to implant placement.

Study Type

INTERVENTIONAL

Interventions

Minimally Invasive tooth extractionPROCEDURE

Tooth extraction will be performed by a calibrated periodontist using a minimally invasive, flapless, atraumatic technique with periotomes and elevators to preserve socket architecture. Granulation tissue will be carefully removed without flap elevation.

Alveolar ridge preservation with ABCCDEVICE

The extraction socket will be grafted with ABCC (SigmaGraft®).

Resorbable collagen membrane (InterCollagen® Guide)DEVICE

A buccal pouch will be created on the buccal aspect, between the bone and the buccal flap, using tunneling instruments to accommodate a resorbable collagen membrane (InterCollagen® Guide; SigmaGraft®). The membrane will be positioned in the buccal tunnel to replace the missing buccal bone wall and provide graft containment.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults aged 18-80 * Indicated for extraction of a single-rooted maxillary tooth * ≥ 50% buccal bone dehiscence confirmed by CBCT reconstructions * Presence of both adjacent teeth * No interproximal bone loss * ASA I-II health status * Ability to comply with required procedures, including attending required number of clinic visits Exclusion Criteria: * Patients diagnosed with periodontitis adjacent to the area to be treated * History of allergic reactions to local anesthetics or bone graft material (self-reported); * Current heavy smokers (≥ 10 cigarettes/day) or those who quit smoking recently (self-reported; last 6 months); * Diagnosis of diabetes mellitus, liver or kidney failure (self-reported); * Presence of active infectious diseases of any kind; * History of chemotherapy or radiation therapy to the head or neck within the past 5 years (self-reported); * Severe hematologic disorders (risk for hemorrhage)(self-reported); * Assumption of corticosteroids, IV bisphosphonates or immunosuppressive drugs; * Any history of alcohol or drug abuse (self-reported); * Pregnancy or plans to become pregnant within 4 months of study enrollment (self-reported);

Outcomes

Primary Outcomes

Horizontal dimensional changes (%)

Change in horizontal ridge width at 3 mm apical to the crest, measured on CBCT scans and expressed in percentage change.