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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
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
The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
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)
Time frame: baseline, at 2,6 months
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
Time frame: baseline, at 2,6 months
change from baseline Gingival index at 2 and 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
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Time frame: at 2 and 6 months post operation
dosage of postoperative analgesic drugs
dosage of postoperative analgesic drugs that patients take after surgery
Time frame: at 1 week after surgery
operation time
measured from the start of the first incision to the end of the last suture
Time frame: during the surgery
esthetic score
assessed by judging on the colour, contour, and texture of the surgical sites
Time frame: 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
Time frame: 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
Time frame: baseline, at 2,6 months