Alveolar Ridge Preservation in Molar Extraction Sockets With an Open Healed Collagen Membrane: A Randomized Clinical Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- alveolar ridge width and height in three plane
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Arms & Interventions
control (natural healing)
Extraction socket is naturally healed
Test 1 (membrane guided regeneration)
Extraction socket is filled with graft (FDBA) and covered with collagen membrane
Intervention: membrane guided regeneration (Procedure)
Test 2 (collagen plug)
Extraction socket is filled with a collagen plug
Intervention: collagen plug (Procedure)
Outcomes
Primary Outcomes
alveolar ridge width and height in three plane
Time Frame: four months after surgery
mesure with CBCT
Secondary Outcomes
- gingival thickness(four months after surgery)