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Effect of Oxidized Regenerated Cellulose on Vestibular Sulcus Depth After Clark Vestibuloplasty

NCT07767682 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-08-17

No results posted yet for this study

Summary

This randomized controlled clinical study will evaluate whether the use of oxidized regenerated cellulose (Reoxcel Sigma Knit) in addition to standard Clark vestibuloplasty improves vestibular sulcus depth and patient comfort in individuals with insufficient vestibular depth. A total of 36 participants will be assigned to either Clark vestibuloplasty with oxidized regenerated cellulose or standard Clark vestibuloplasty with periodontal dressing. Vestibular sulcus depth and keratinized gingival tissue will be assessed before treatment and at 1 and 3 months after surgery. Postoperative pain and analgesic use will also be evaluated during the first 7 days after surgery.

Conditions

  • Insufficient Vestibular Sulcus Depth

Interventions

DEVICE

Oxidized Regenerated Cellulose (ORC)

Oxidized regenerated cellulose (Reoxcel Sigma Knit, 5 × 7.5 cm) will be applied in a double layer over the exposed gingival wound surface following standard Clark vestibuloplasty. The material will be secured with 4-0 polyglycolide-lactide sutures using crossed and simple suturing techniques.

DEVICE

Periodontal Dressing

Periodontal dressing (Coe-Pak) will be applied over the exposed gingival wound surface following standard Clark vestibuloplasty. The dressing will cover the surgical site during the postoperative healing period.

Sponsors & Collaborators

  • Izmir Katip Celebi University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-09
Primary Completion
2027-06-30
Completion
2027-07-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07767682 on ClinicalTrials.gov