Augmentation of Keratinized Tissue Around Dental Implant With a Xenogeneic Collagen Matrix and the Free Gingival Graft
- Conditions
- Inadequately Attached Gingiva
- Interventions
- Procedure: apically repositioned flap+ xenogeneic collagen matrix +free gingival graft
- Registration Number
- NCT05273476
- Lead Sponsor
- The Dental Hospital of Zhejiang University School of Medicine
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description strip apically repositioned flap+ xenogeneic collagen matrix +free gingival graft apically repositioned flap+ xenogeneic collagen matrix +free gingival graft
- Primary Outcome Measures
Name Time Method change from baseline keratinized mucosa width at 2 and 6 months 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 Outcome Measures
Name Time Method change from 2 months patient satisfaction at 6 months at 2 and 6 months post operation using a visual analog scale (VAS) ranging from 0 to 10 (0 = extremely dissatisfied and 10 = extremely satisfied)
change from baseline keratinized mucosa thickness at 2 and 6 months baseline, at 2,6 months measured at the middle point of an apical-coronal direction at the mid-buccal aspect using an endodontic file with a rubber stop
Post-operative pain at 1 week after surgery evaluated using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)
change from baseline Gingival index at 2 and 6 months baseline, at 2,6 months assessed at four gingival sites of each implant (mesio-labial/buccal, mid-labial/buccal, disto-labial/buccal, and palatal/lingual) . Indicated by numbers, 0: normal gingiva; 1: slightly edematous gingiva that does not bleed on probing; 2: edematous gingiva that bleeds on probing; 3: gingiva that has a tendency to bleed spontaneously or ulcerate.
change from baseline probing depth at 2 and 6 months baseline, at 2,6 months measured at six sites of each implant (mesio-labial/buccal, mid-labial/buccal, disto-labial/buccal, mesio-palatal/lingual, mid-palatal/lingual, and disto-palatal/lingual) using a periodontal probe (UNC15)
dosage of postoperative analgesic drugs at 1 week after surgery dosage of postoperative analgesic drugs that patients take after surgery
operation time during the surgery measured from the start of the first incision to the end of the last suture
esthetic score at 6 months post operation assessed by judging on the colour, contour, and texture of the surgical sites
change from baseline depth of recession at 2 and 6 months baseline, at 2,6 months The distance from the implant margin to the gingival margin was measured with a periodontal probe
change from baseline width of recession at 2 and 6 months baseline, at 2,6 months The proximal and distal level of soft tissue retraction at the top of implant was measured by periodontal probe
Trial Locations
- Locations (1)
The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China