Augmentation of Keratinized Tissue Around Dental Implant With a Xenogeneic Collagen Matrix and the Free Gingival Graft

NCT05273476 | Completed

• 1 other identifier: DHZhejiangU-2022（023）
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the clinical effects of combined application of combined application of a xenogeneic collagen matrix and the free gingival graft in augmentation of keratinized tissue around dental implant by single arm clinical trial, compared with historical control group 1:application of a xenogeneic collagen matrix,and historical control group 2:application of the free gingival graft.

Conditions

Inadequately Attached Gingiva

Outcome Measures

Primary Outcomes (1)

• change from baseline keratinized mucosa width at 2 and 6 months

  measured from the mucogingival junction to the mucosa margin or the zenith of alveolar ridge at the mid-buccal aspect of each implant using a periodontal probe (UNC15)

  baseline, at 2,6 months

Secondary Outcomes (10)

• change from baseline keratinized mucosa thickness at 2 and 6 months

  baseline, at 2,6 months

• change from baseline Gingival index at 2 and 6 months

  baseline, at 2,6 months

• change from baseline probing depth at 2 and 6 months

  baseline, at 2,6 months

• Post-operative pain

  at 1 week after surgery

• change from 2 months patient satisfaction at 6 months

  at 2 and 6 months post operation

Study Arms (1)

strip

EXPERIMENTAL

apically repositioned flap+ xenogeneic collagen matrix +free gingival graft

Procedure: apically repositioned flap+ xenogeneic collagen matrix +free gingival graft

Interventions

apically repositioned flap+ xenogeneic collagen matrix +free gingival graft PROCEDURE

Harvest a strip free gingival graft from the palate, then place it above apically repositioned flap and fix xenogeneic collagen matrix to the recipient bed

strip

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged \>=18 years and periodontally and systemically healthy;
• Presence of at least one site with \<=2 mm of keratinized tissue; associated with a shallow vestibule in the edentulous region after implant surgery (no more than three consecutive implants);
• Need of keratinized tissue augmentation for aesthetic purpose and/or functional reasons;
• Full mouth probing depths \<=5mm;
• Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) \<=15%;
• Be able to comply with all procedures related to the study.

You may not qualify if:

• Smoking;
• Pregnant or lactating women;
• Untreated periodontal disease;
• Presence of systemic disorders (diabetes, heart disease, tumor or any other condition that could contraindicate periodontal surgery);
• Use of medications (immunosuppressants, phenytoin, or anything else that might affect mucosal healing and repair);
• Under radiotherapy;
• Allergy to the collagen;
• Previous mucogingival surgery in the area.

Sponsors & Collaborators

• The Dental Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

The Affiliated Stomatology Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Study Officials

• Peihui Ding, Doctor

  The Affiliated Stomatology Hospital of Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 10, 2022
• Study Start: March 15, 2022
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)