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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-15

Study Completion Date

2024-12-31

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.

Detailed Description

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Conditions

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Tooth Extraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control (natural healing)

Extraction socket is naturally healed

Group Type NO_INTERVENTION

No interventions assigned to this group

Test 1 (membrane guided regeneration)

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

Group Type EXPERIMENTAL

membrane guided regeneration

Intervention Type PROCEDURE

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

Test 2 (collagen plug)

Extraction socket is filled with a collagen plug

Group Type ACTIVE_COMPARATOR

collagen plug

Intervention Type PROCEDURE

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)

Intervention Type PROCEDURE

collagen plug

after tooth extraction, the socket was filled with collagen plug

Intervention Type PROCEDURE

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chen-Ying Wang, PHD

Role: CONTACT

+886-972-651-897

Chen-Ying Wang, PHD

Role: CONTACT

+886-972-651-897

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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