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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| strip | Experimental | apically repositioned flap+ xenogeneic collagen matrix +free gingival graft |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| apically repositioned flap+ xenogeneic collagen matrix +free gingival graft | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline keratinized mucosa width at 2 and 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) | baseline, at 2,6 months |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline keratinized mucosa thickness at 2 and 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 | baseline, at 2,6 months |
| change from baseline Gingival index at 2 and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peihui Ding, Doctor | The Affiliated Stomatology Hospital of Zhejiang University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Stomatology Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
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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. |
| baseline, at 2,6 months |
| change from baseline probing depth at 2 and 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) | baseline, at 2,6 months |
| Post-operative pain | evaluated using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable) | at 1 week after surgery |
| change from 2 months patient satisfaction at 6 months | using a visual analog scale (VAS) ranging from 0 to 10 (0 = extremely dissatisfied and 10 = extremely satisfied) | at 2 and 6 months post operation |
| dosage of postoperative analgesic drugs | dosage of postoperative analgesic drugs that patients take after surgery | at 1 week after surgery |
| operation time | measured from the start of the first incision to the end of the last suture | during the surgery |
| esthetic score | assessed by judging on the colour, contour, and texture of the surgical sites | at 6 months post operation |
| change from baseline depth of recession at 2 and 6 months | The distance from the implant margin to the gingival margin was measured with a periodontal probe | baseline, at 2,6 months |
| change from baseline width of recession at 2 and 6 months | The proximal and distal level of soft tissue retraction at the top of implant was measured by periodontal probe | baseline, at 2,6 months |