NCT04802148

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 17, 2021

Completed
29 days until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 6, 2023

Status Verified

April 1, 2022

Enrollment Period

3.7 years

First QC Date

March 14, 2021

Last Update Submit

February 3, 2023

Conditions

Tooth Extraction

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • alveolar ridge width and height in three plane

    mesure with CBCT

    four months after surgery

Secondary Outcomes (1)

  • gingival thickness

    four months after surgery

Study Arms (3)

control (natural healing)

NO INTERVENTION

Extraction socket is naturally healed

Test 1 (membrane guided regeneration)

EXPERIMENTAL

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

Procedure: membrane guided regeneration

Test 2 (collagen plug)

ACTIVE COMPARATOR

Extraction socket is filled with a collagen plug

Procedure: collagen plug

Interventions

membrane guided regenerationPROCEDURE

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

Test 1 (membrane guided regeneration)
collagen plugPROCEDURE

after tooth extraction, the socket was filled with collagen plug

Test 2 (collagen plug)

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Interventions

Punctal Plugs

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Central Study Contacts

Chen-Ying Wang, PHD

CONTACT

+886-972-651-897jybean@gmail.com

Chen-Ying Wang, PHD

CONTACT

+886-972-651-897jywang8919@ntu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2021

First Posted

March 17, 2021

Study Start

April 15, 2021

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

February 6, 2023

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)