Alveolar Ridge Preservation in Molar Extraction Sockets With an Open Healed Collagen Membrane: A Randomized Clinical Trial.

Study Overview
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Brief Summary
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The resorption of alveolar ridge after tooth extraction develop difficulty in restoring the extraction area with implant or bridge. Therefore, try to preserve the alveolar ridge width and height at extraction socket and gaining its bone volume in maximal is worth for clinical investigation. There are several method to deal with alveolar ridge preservation (ARP), the most popular way for its approach, the trend is toward to minimally invasive treatment. Alveolar ridge preservation which is done with open-healed wound without primary closure is the key for minimally invasive approach. This three-armed randomized clinical trial would like to determine the effect of applying ribose cross-linked collagen membrane without primary flap closure in molar extraction sockets for alveolar ridge preservation. The procedure is for implant site development. Three groups were designed as test group1 was grafted with freeze dried bone allograft (FDBA) and covered by ribose cross-linked collagen membrane (OSSIX® PLUS). In test group2 sockets filled with collagen plug(Teruplug®) and sockets healed naturally as control group. Cone-beam computed tomography(CBCT) scans are obtained immediately and 4 months after ARP as the primary outcome and secondary outcome. A biopsy from implant site and histomorphometric analysis will be done as well. The change of marginal bone level and the width/height of keratinized mucosa are measured.

Official Title
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Alveolar Ridge Preservation in Molar Extraction Sockets With an Open Healed Collagen Membrane: A Randomized Clinical Trial.

Conditions
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Tooth Extraction

Intervention / Treatment
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* Procedure: membrane guided regeneration
* Procedure: collagen plug


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age>20 according to periapical film, the bone defect over bucco-lingual and mesio-distal direction less than 50% patient agreed to undergo implant therapy after tooth extraction Exclusion Criteria: systemic diseases which will affect wound healing (ex. Diebetes) heavy smoker (10 cigarette/day) patient who underwent oral-maxillary surgery or who diagnosed with oral cancer patient who is pregnant or who is breast-feeding patient who is allergic to Lidocaine patient who cannot cooperate the study design

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control (natural healing)<br>Extraction socket is naturally healed | |
| Experimental: Test 1 (membrane guided regeneration)<br>Extraction socket is filled with graft (FDBA) and covered with collagen membrane | Procedure: membrane guided regeneration<br>* after tooth extraction, the socket was filled with membrane and graft (FDBA)<br>|
| Active Comparator: Test 2 (collagen plug)<br>Extraction socket is filled with a collagen plug | Procedure: collagen plug<br>* after tooth extraction, the socket was filled with collagen plug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| alveolar ridge width and height in three plane | mesure with CBCT | four months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gingival thickness | measure with CBCT and clinical observation | four months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ridge preservation, tooth extraction, collagen membrane, cone-beam computed tomography