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Application of gelatin-polycaprolactone gingival repair membrane in oral gingival soft tissue augmentation

Application of gelatin-polycaprolactone gingival repair membrane in oral gingival soft tissue augmentation - Application of gelatin-polycaprolactone gingival repair membrane in oral gingival soft tissue augmentation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093615
Enrollment
Unknown
Registered
2024-12-09
Start date
2024-12-18
Completion date
Unknown
Last updated
2024-12-16

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

Conditions

Soft tissue deficiency

Interventions

Experimental group of keratinized gingiva augmentation:keratinized gingiva augmentation with gelatin-polycaprolactone gingival repair film
Control group of keratinized gingiva augmentation:None, routine implant surgery is performed
Experimental group of alveolar ridge preservation:Alveolar ridge preservation with gelatin-polycaprolactone gingival repair film
Control group of alveolar ridge preservation:None, regular sites are saved
Experimental group of peri-implant soft tissue augment:Peri-implant soft tissue augment with gelatin-polycaprolactone gingival repair film

Sponsors

Zhejiang Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Experiment 1: (1) Patients aged >=18 years old, healthy in the past, without complaints of systemic diseases; (2) insufficient keratinized gingiva; (3) no acute periodontal inflammation; (4) no infection of soft tissue wound; (5) Patients had good compliance; (6) agree to participate in this clinical trial and sign the informed consent. Experiment 2: 1) 18 years old = 3mm; 4) no acute periodontal inflammation; 5) those with good compliance and can cooperate to complete the whole clinical trial; 6) Able to understand the purpose of the trial, voluntarily participate and sign informed consent. Experiment 3: 1) 18 years old <= age <=70 years old, regardless of gender; 2) patients with labial and buccal gingival depression requiring soft tissue augmentation in the second stage of implant placement; 3) no acute periodontal inflammation; 4) those with good compliance and can cooperate to complete the whole clinical trial; 5) Able to understand the purpose of the trial, voluntarily participate and sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Acute infection of affected teeth or adjacent teeth and soft tissues; (2) female patients during pregnancy or lactation; (3) taking drugs affecting platelet or bone regeneration within 3 months; (4) patients with a history of head and neck radiotherapy and uncontrolled systemic diseases; (5) heavy smokers, smoking more than 10 cigarettes/day; (6) Gelatin allergy.

Design outcomes

Primary

MeasureTime frame
Keratinized gingival width at 6 months after surgery;

Secondary

MeasureTime frame
Changes in alveolar bone height and width at 6 months after surgery;

Countries

China

Contacts

Public ContactFan Yang

Zhejiang Provincial People's Hospital

yangfan@hmc.edu.cn+86 571 8589 3206

Outcome results

None listed

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