Alveolar Ridge Preservation in Molar Extraction Sockets With an Open Healed Collagen Membrane: A Randomized Clinical Trial.
NCT ID: NCT04802148
Last Updated: 2023-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2021-04-15
2024-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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control (natural healing)
Extraction socket is naturally healed
No interventions assigned to this group
Test 1 (membrane guided regeneration)
Extraction socket is filled with graft (FDBA) and covered with collagen membrane
membrane guided regeneration
after tooth extraction, the socket was filled with membrane and graft (FDBA)
Test 2 (collagen plug)
Extraction socket is filled with a collagen plug
collagen plug
after tooth extraction, the socket was filled with collagen plug
Interventions
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membrane guided regeneration
after tooth extraction, the socket was filled with membrane and graft (FDBA)
collagen plug
after tooth extraction, the socket was filled with collagen plug
Eligibility Criteria
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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
* 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
20 Years
ALL
Yes
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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CHEN-YING WANG, PhD
Role: primary
Other Identifiers
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202004006RINB
Identifier Type: -
Identifier Source: org_study_id
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