Inadequately Attached Gingiva
Conditions
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.
Interventions
PROCEDUREapically repositioned flap+ xenogeneic collagen matrix +free gingival graft
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
Sponsors
The Dental Hospital of Zhejiang University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| 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 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) |
| 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 |
Countries
China
Outcome results
None listed