Effect of Collagen Membrane on Ridge Preservation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorDebora Dias
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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);
Trial design
Design model
Parallel
Treatments tested in this trial
Minimally Invasive tooth extraction
Procedure/SurgeryTooth 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 ABCC
DeviceThe extraction socket will be grafted with ABCC (SigmaGraft®).
Resorbable collagen membrane (InterCollagen® Guide)
DeviceA 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Control group (bone graft only)Active comparator 2 interventions
Group B: Test group (bone graft + collagen membrane)Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Horizontal dimensional changes (%)
Change in horizontal ridge width at 3 mm apical to the crest, measured on CBCT scans and expressed in percentage change.
Time frame
Baseline and 4 monthsSecondary outcomes
1
Horizontal dimensional changes (%)
Change in horizontal ridge width at 1 mm apical to the crest, measured on CBCT scans and expressed in percentage change.
Time frame
Baseline and 4 months2
Horizontal dimensional changes (%)
Change in horizontal ridge width at 5 mm apical to the crest, measured on CBCT scans and expressed in percentage change.
Time frame
Baseline and 4 months3
Vertical dimensional changes (%)
Change in vertical ridge height at the midbuccal aspect, measured on CBCT scans and expressed in percentage change.
Time frame
Baseline and 4 months4
Vertical dimensional changes (%)
Change in vertical ridge height at the mid palatal aspect, measured on CBCT scans and expressed in percentage change.
Time frame
Baseline and 4 monthsSponsors and contacts
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Source ClinicalTrials.gov