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

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 Overview

• Status: Recruiting
• Conditions: Tooth Extraction
• Intervention / Treatment: Procedure: membrane guided regeneration; Procedure: collagen plug

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: CHEN-YING WANG, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2021
• Primary Completion (ANTICIPATED): December 31, 2024
• Study Completion (ANTICIPATED): December 31, 2024

Study Registration Dates

• First Submitted: March 14, 2021
• First Submitted That Met QC Criteria: March 14, 2021
• First Posted (ACTUAL): March 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: ridge preservation, tooth extraction, collagen membrane, cone-beam computed tomography
• Other Study ID Numbers: 202004006RINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No