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A clinical trial of the effect of a partial-thickness modified apically positioned flap and gelatin-polycaprolactone biohybrid polymers membrane on increasing the dimensions of attached gingiva around implants in the posterior area.

A clinical trial of the effect of a partial-thickness modified apically positioned flap and gelatin-polycaprolactone biohybrid polymers membrane on increasing the dimensions of attached gingiva around implants in the posterior area.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109321
Enrollment
Unknown
Registered
2025-09-16
Start date
2025-09-18
Completion date
Unknown
Last updated
2025-09-22

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

Conditions

Insufficient width of the peri-implant keratinized gingiva

Interventions

test group:a partial-thickness modified apically positioned flap and gelatin-polycaprolactone biohybrid polymers membrane
control group:a partial-thickness modified apically positioned flap and free gingival graft

Sponsors

Peking University School and Hospital of Stomatology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
28 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Adult patients: aged 18 to 80 years; (2) Stable implant-supported restoration in the mandibular posterior region, with no complications such as implant failure or loosening; (3) Insufficient keratinized gingival width (less than 4mm but greater than 2mm) following Phase I implant surgery and prior to Phase II surgery (bone grafting optional): measured using periodontal probing as the total width of keratinized gingiva at the crest of the alveolar ridge; (4) Systemically healthy patients with fasting blood glucose <=6.11 mmol/L; (5) Non-smokers or smokers limited to <=10 cigarettes/day; (6) Periodontally healthy with a plaque index <20% for the entire dentition.

Exclusion criteria

Exclusion criteria: (1) Patients with systemic diseases such as diabetes, osteoporosis, or hepatitis; (2) Patients with physical or mental conditions affecting daily oral hygiene maintenance (e.g., bruxism, Parkinson's disease); (3) Pregnant women, breastfeeding individuals, or those planning pregnancy. (4) Patients taking steroids, antiepileptic drugs, medications causing drug-induced gingival hyperplasia, bisphosphonates, or other drugs affecting bone metabolism. (5) Patients unable to comply with this study. (6) Sites with reduced vertical bone height in the posterior region, insufficient gingival-buccal sulcus depth, or less than 5mm apical displacement of the flap during surgery will be excluded.

Design outcomes

Primary

MeasureTime frame
Increase in keratinized gingiva width Six months after restoration;

Secondary

MeasureTime frame
Duration of surgery;Increase in keratinized gingiva width immediately after surgery;Patient satisfaction;Patient Anxiety Index;Increase in keratinized gingiva width Six weeks after surgery;Increase in keratinized gingiva width immediately after surgery;Enhance soft tissue color;Enhance soft tissue texture;Plaque index six months after restoration;bleeding index six months after restoration;Probing depth six months after restoration;gingival recession six months after restoration;Thickness before surgery;Thickness six months after restoration;marginal bone loss six months after restoration;

Countries

China

Contacts

Public ContactJia Pingyi

Peking University School and Hospital of Stomatology

msjiapingyi@163.com+86 131 2191 7570

Outcome results

None listed

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