Periodontal soft tissue insufficient
Conditions
Interventions
experimental group:Absorbale Gradient Membrane
control group:Free gingival graft
Sponsors
Affiliated Stomatological Hospital, Medical School of Nanjing University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18 to 70 years old, males or females; (2) Patients who need periodontal soft tissue increment treatment such as widened keratinized gingiva and deepened; vestibular sulcus, etc. (3) Those who agree to participate in the clinical trial and sign the informed consent voluntarily.
Exclusion criteria
Exclusion criteria: (1) Patients who have undergone soft tissue incremental treatment at the treatment site; (2) Patients with infection at the treatment site; (3) Patients with complete loss of keratinized gingiva at the treatment site; (4) Patients who still need orthodontic tooth movement in the operation area during the trial; (5) Those who have not completed the basic periodontal treatment before surgery; (6) Patients undergoing bone augmentation at the same time at the treatment site; (7) Patients with severe liver and kidney abnormalities (any index of ALT/AST/Cr/BUN/UREA>1.5 times the upper limit of normal value); (8) Patients with poor blood glucose control (fasting blood glucose > 8.0 mmol/L); (9) Patients with severe hypertension who are not controlled to stable (systolic blood pressure >= 160 mmHg and/or diastolic blood pressure >= 100 mmHg); (10) Patients with Severe abnormal blood coagulation function or platelets 10 cigarettes/ tobacco equivalents /chewing tobacco per day; (15) Patients with other contraindications for periodontal surgery; (16) Women who are pregnant/lactating or have a pregnancy plan within half a year; (17) Patients within 3 months or participating in clinical trials of other drugs/medical devices; (18) Other patients considered unsuitable for this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Width increment of keratinized gingival ; | — |
Secondary
| Measure | Time frame |
|---|---|
| performance evaluation of devices;plaque index;probing depth,PD;( bleeding index, BI);Gingival recession;Width of keratinized gingival;VAS pain score;Operation time;soft tissue survival rate of Implant area;Wound healing;Surgery area satisfaction assessment; | — |
Countries
China
Contacts
Public ContactYan Fuhua
Affiliated Stomatological Hospital, Medical School of Nanjing University
Outcome results
None listed