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

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04802148

Collaborator

(none)

Enrollment

Arms

14.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tooth Extraction	Procedure: membrane guided regeneration Procedure: collagen plug	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

No Intervention: control (natural healing)

Extraction socket is naturally healed

Experimental: Test 1 (membrane guided regeneration)

Extraction socket is filled with graft (FDBA) and covered with collagen membrane

Procedure: membrane guided regeneration

after tooth extraction, the socket was filled with membrane and graft (FDBA)

Active Comparator: Test 2 (collagen plug)

Extraction socket is filled with a collagen plug

Procedure: collagen plug

after tooth extraction, the socket was filled with collagen plug

Outcome Measures

Primary Outcome Measures

alveolar ridge width and height in three plane [four months after surgery]
mesure with CBCT

Secondary Outcome Measures

gingival thickness [four months after surgery]
measure with CBCT and clinical observation

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT04802148

Other Study ID Numbers:

202004006RINB

First Posted:

Mar 17, 2021

Last Update Posted:

Mar 17, 2021

Last Verified:

Aug 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by National Taiwan University Hospital

ridge preservation, tooth extraction, collagen membrane, cone-beam computed tomography

Study Results

No Results Posted as of Mar 17, 2021