Clinical trial NCT05273476: Augmentation of Keratinized Tissue Around Dental Implant With a Xenogeneic Collagen Matrix and the Free Gingival Graft
Official title: Augmentation of Keratinized Tissue Around Dental Implant With Combined Application of a Xenogeneic Collagen Matrix and the Free Gingival Graft : a Single Arm Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inadequately Attached Gingiva
Lead sponsor: The Dental Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: change from baseline keratinized mucosa width at 2 and 6 months
timeFrame: baseline, at 2,6 months
Secondary outcomes:
measure: change from baseline keratinized mucosa thickness at 2 and 6 months
timeFrame: baseline, at 2,6 months
measure: change from baseline Gingival index at 2 and 6 months
timeFrame: baseline, at 2,6 months
measure: change from baseline probing depth at 2 and 6 months
timeFrame: baseline, at 2,6 months
measure: Post-operative pain
timeFrame: at 1 week after surgery
measure: change from 2 months patient satisfaction at 6 months
timeFrame: at 2 and 6 months post operation
measure: dosage of postoperative analgesic drugs
timeFrame: at 1 week after surgery
measure: operation time
timeFrame: during the surgery
measure: esthetic score
timeFrame: at 6 months post operation
measure: change from baseline depth of recession at 2 and 6 months
timeFrame: baseline, at 2,6 months
measure: change from baseline width of recession at 2 and 6 months
timeFrame: baseline, at 2,6 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
name: Peihui Ding, Doctor
role: PRINCIPAL_INVESTIGATOR
References: