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Study on the Efficacy of Comparing H-PRF Membranes and De - epithelialized Gingival Grafts for Labial Soft Tissue Thickening of Implants in Aesthetic Zone

Study on the efficacy of platelet-rich fibrin membrane versus epithelial-denuded gingival graft in increasing the thickness of labial soft tissue around implants in the aesthetic zone

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109644
Enrollment
Unknown
Registered
2025-09-23
Start date
2026-01-12
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Repair and correction of dental defects and missing teeth

Interventions

Experimental group:During the second stage, the H-PRF membrane is simultaneously used for soft tissue thickening
Control group:During the second-stage surgery, de-epithelialized gingival tissue is simultaneously used for soft tissue thickening

Sponsors

Stomatological Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with missing maxillary anterior teeth (at most two teeth) who have placed dental implant at least 3 months. 2. The tissue contour at the implant site exhibits collapse compared to the adjacent natural teeth before stage-two surgery. 3. The mesial and distal adjacent teeth present with good periodontal status. 4. The palatal mucosa in the donor site exhibited normal morphology. 5. The patient had no uncontrolled systemic diseases. 6. Patients with good oral environment and high compliance. 7. The patients voluntarily participated and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women and individuals with pregnancy plans within the next 6 months. 2. Heavy smokers (>10 cigarettes/day). 3. Patients with severe diseases of vital organs (heart, liver, lung, kidney) or uncontrolled serious hematologic, immune, or endocrine disorders, as well as any metabolic disease that may negatively affect soft tissue healing. 4. Poorly controlled diabetes (fasting blood glucose =8.0 mmol/L despite medication). 5. Patients with untreated periodontitis, acute apical periodontitis, periapical abscess, and/or moderate to advanced periodontal disease. 6. Patients with poor oral hygiene who cannot maintain adequate oral care. 7. Patients taking medications that cause gingival enlargement or the presence of gingival idiopathic overgrowth. 8. Perioperative use of medications that may interfere with tissue repair, including but not limited to glucocorticoids and other anti-inflammatory agents. 9. Soft tissue augmentation has been done in the implant site.

Design outcomes

Primary

MeasureTime frame
Soft tissue thickness at the labial alveolar ridge crest level;

Secondary

MeasureTime frame
Soft tissue thickness change at 1mm and 2mm level below the labial alveolar ridge crest;Surgical time;Peri-implant tissue health status (including plaque index, bleeding on probing, probing pocket depth , and marginal bone level);Marginal bone loss;Aesthetic evaluation;Patient satisfaction and comfort;Soft tissue volume change;

Countries

China

Contacts

Public ContactZhang Yufeng

Stomatological Hospital of Wuhan University

zyf@whu.edu.cn+86 186 0719 8656

Outcome results

None listed

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