An interventional study of Oxidized Regenerated Cellulose (ORC) and Periodontal Dressing in Insufficient Vestibular Sulcus Depth, sponsored by Izmir Katip Celebi University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Izmir Katip Celebi University · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Participants in this arm will undergo standard Clark vestibuloplasty. In addition, oxidized regenerated cellulose (Reoxcel Sigma Knit) will be applied over the surgical wound in a double layer and secured with sutures.
Device: Oxidized Regenerated Cellulose (ORC)
Participants in this arm will undergo standard Clark vestibuloplasty. Following surgery, the exposed gingival wound surface will be covered with a periodontal dressing (Coe-Pak) without the application of oxidized regenerated cellulose.
Device: Periodontal Dressing
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 (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.
Change in Vestibular Sulcus Depth
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.
Time frame: Baseline, 1 month, and 3 months after surgery
Postoperative Pain Assessed by Visual Analog Scale (VAS)
Postoperative pain intensity will be assessed using a Visual Analog Scale ranging from 0 (no pain) to 10 (unbearable pain). Participants will record their pain score daily after surgery.
Time frame: Daily for 7 days after surgery
Postoperative Pain Assessed by Wong-Baker Faces Pain Rating Scale
Postoperative pain will be assessed using the Wong-Baker Faces Pain Rating Scale, which consists of six facial expressions ranging from a happy face representing no pain to a distressed face representing the worst pain. At the end of each day, participants will select the face that best represents the pain they experienced that day.
Time frame: Daily for 7 days after surgery
Postoperative Analgesic Consumption
Participants will record the number of analgesic tablets taken each day after surgery. Total analgesic consumption will be used to compare postoperative discomfort between the study groups.
Time frame: Daily for 7 days after surgery
Plan to share: No
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Izmir Katip Celebi University