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

The Dental Hospital of Zhejiang University School of Medicine

Status: Completed

Conditions: Inadequately Attached Gingiva

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05273476

DHZhejiangU-2022（023）

Details and patient eligibility

About

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.

Full description

The purpose of this study is to compare the clinical effects 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. This study designed a single arm clinical trial. The included patients will all be treated with apical repositioned flap with a xenogeneic collagen matrix and the free gingival graft. The width of keratinized mucosa, thickness of keratinized mucosa, gingival index, probing depth will be measured before surgery and at 2, 6 months postoperatively.

Enrollment: 13 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged >=18 years and periodontally and systemically healthy;
2. 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);
3. Need of keratinized tissue augmentation for aesthetic purpose and/or functional reasons;
4. Full mouth probing depths <=5mm;
5. Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) <=15%;
6. Be able to comply with all procedures related to the study.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

strip

Experimental group

Description:

apically repositioned flap+ xenogeneic collagen matrix +free gingival graft

Treatment:

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