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Study on the application of gelatin-polyvinylidene chloride layered gingival repair membrane in flap anchoring technique

Study on the application of gelatin-polyvinylidene chloride layered gingival repair membrane in flap anchoring technique

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105720
Enrollment
Unknown
Registered
2025-07-09
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insufficient keratinized gingiva

Interventions

Augmented Gingival Matrix (AGM) Group:Gelatin polyvinyl acetate layered gingival repair membrane will be used for flap anchoring technique to increase soft tissue
Free gingival graft (FGG) Group:The flap anchoring technique using autologous free gingival grafts was used to increase the soft tissue

Sponsors

Stomatological Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Voluntary signing of informed consent; 2.Patients who have undergone dental implant surgery and/or bone grafting and whose keratinized mucosa associated with a shallow gingival sulcus is less than or equal to 2 mm after implant surgery. 3.System health patients (American Society of Anesthesiologists-ASAI, grade II: mild complications except for surgical diseases, with sound functional compensation); 4.The patient is over 18 years old and well compliant during the operation; 5.The periodontal status is in the periodontal maintenance phase (plaques index <20%, probing bleeding score <10%); 6.Sufficient palatal keratinized gingival tissue is obtained as donor material to obtain the required autologous free connective tissue flap.

Exclusion criteria

Exclusion criteria: 1. Suffering from systemic diseases with contraindications to conventional implant surgery or uncontrollable systemic diseases; (1) Severe systemic diseases: 1) Have high blood pressure and have systolic blood pressure (high pressure) > 150mmHg or diastolic blood pressure (low pressure) > 90mmHg; 2) Have uncontrolled diabetes mellitus: fasting blood glucose = 7.0mmol/L or glycosylated hemoglobin (HbA1c>7%); 3) Suffering from heart disease (cardiac function grade 3-4), or symptoms such as orthopnea, edema of the lower limbs, etc.; 4) Patients with cardiopulmonary diseases and heart failure; 5) Suffering from cardiovascular and cerebrovascular diseases (angina, myocardial infarction, cerebral infarction, and angina pectoris within half a year); 6) Suffering from third- or second-degree type II atrioventricular block, double bundle branch block, Ass syndrome; 7) Suffering from heart valve disease; 8) acute hepatitis (which can cause severe damage to the liver); 9) severe asthma, severe pharyngitis, major depression; 10) Severe hyperthyroidism: pulse rate > 100 beats/min, basal metabolic rate >20%; 11) Blood diseases: patients with hemophilia, leukemia and other bleeding disorders, or coagulation disorders caused by taking anticoagulant drugs, have clinically significant abnormalities in INR>3 or seven items of coagulation; (2) Long-term use of the following drugs: 1) Injection and large amounts of oral bisphosphonates for the prevention of bone metastasis and the treatment of osteoporosis patients; 2) Patients with joint necrosis caused by the use of hormone drugs (typical cases: patients with SARS); 3) patients on long-term adrenocorticosteroid therapy; (3) AIDS, syphilis and drug addicts; (4) Patients who are physically unable to tolerate surgery due to other systemic diseases; (5) Pathological changes in the gums and surrounding hard tissues; 2. Patients with acute or severe infection, white blood cell count > 10×10^9/L; 3. There is abnormal occlusal relationship or bad occlusion habit around the soft tissue defect area, which may cause traumatic absorption of soft tissue around the implant and lead to surgical failure; oral mucosal lesions; Severe soft tissue inflammatory lesions in the edentulous area; limited mouth opening; 4. History of drug allergy: severe allergic symptoms to various drugs such as narcotic drugs, anti-inflammatory and analgesics that need to be used during and after surgery; 5. Women who are pregnant, menstruating, or lactating; 6. Those with uncontrolled periodontal disease or poor oral hygiene habits that cannot be improved (probing depth >4mm, BOP>10%); 7. Heavy smokers (> 10 cigarettes/day); 8. Patients with other systemic diseases that may affect wound healing after evaluation, such as chronic tuberculosis, hypothyroidism, autoimmune diseases, etc.; 9. History of malignant tumors, history of radiotherapy or chemotherapy for malignant tumors in the past 5 years; 10. Those who are considered by the investigator to be inappropriate to participate in this clinical trial for other reasons.

Design outcomes

Primary

MeasureTime frame
Width of keratinized gingiva;

Secondary

MeasureTime frame
Transplanted tissue shrinkage;The duration of surgery;Postoperative adverse reactions and complications;

Countries

China

Contacts

Public ContactZehong Guo

Stomatological Hospital of Southern Medical University

36648547@qq.com+86 13728098343

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026