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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Inadequately Attached Gingiva
- Sponsor
- The Dental Hospital of Zhejiang University School of Medicine
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- change from baseline keratinized mucosa width at 2 and 6 months
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Peihui Ding
Principal Investigator
The Dental Hospital of Zhejiang University School of Medicine
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
change from baseline keratinized mucosa width at 2 and 6 months
Time Frame: baseline, at 2,6 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)
Secondary Outcomes
- change from baseline keratinized mucosa thickness at 2 and 6 months(baseline, at 2,6 months)
- Post-operative pain(at 1 week after surgery)
- 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)
- change from 2 months patient satisfaction at 6 months(at 2 and 6 months post operation)
- dosage of postoperative analgesic drugs(at 1 week after surgery)
- operation time(during the surgery)
- esthetic score(at 6 months post operation)
- change from baseline depth of recession at 2 and 6 months(baseline, at 2,6 months)
- change from baseline width of recession at 2 and 6 months(baseline, at 2,6 months)