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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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.

Eligibility

Primary outcome measure(s)

• Change in Vestibular Sulcus Depth — Baseline, 1 month, and 3 months after surgery
  Vestibular sulcus depth will be measured using a UNC-15 periodontal probe from the gingival margin to the deepest point of the vestibular sulcus. Measurements will be recorded before surgery and repeated at follow-up visits to evaluate the change in vestibular sulcus depth.

Trial sites (1)

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