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

Tooth Extraction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04802148
• Other study ID #: 202004006RINB
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2022
• Source: National Taiwan University Hospital
• Contact: Chen-Ying Wang, PHD
• Phone: +886-972-651-897
• Email: jybean[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tooth Extraction

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	alveolar ridge width and height in three plane	mesure with CBCT	four months after surgery
Secondary	gingival thickness	measure with CBCT and clinical observation	four months after surgery