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

NCT07767682 — Not applicable, Recruiting, 36 participants, Izmir Katip Celebi University

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The Effect of Using Oxidized Regenerated Cellulose Material in Addition to the Standard Clark Vestibuloplasty Technique on Increasing Vestibular Sulcus Depth

Registry	NCT07767682
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	36 (Estimated)
Sponsor	Izmir Katip Celebi University (Other)
Conditions	Insufficient Vestibular Sulcus Depth
Interventions	Oxidized Regenerated Cellulose (ORC), Periodontal Dressing (Device)
Dates	start 2026-04-09, primary completion 2027-06-30 (estimated), completion 2027-07-30 (estimated), first posted 2026-08-17, last updated 2026-08-17
Locations	1 site in Turkey (Türkiye)

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Clark Vestibuloplasty + Oxidized Regenerated Cellulose	Experimental	Device: Oxidized Regenerated Cellulose (ORC)	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.
Standard Clark Vestibuloplasty	Active comparator	Device: Periodontal Dressing	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.

Oxidized Regenerated Cellulose (ORC) (Device): 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 (Device): 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.

+Outcome measures

Primary outcomes

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.

Secondary outcomes

Postoperative Pain Assessed by Visual Analog Scale (VAS) [Daily for 7 days after surgery]: 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.
Postoperative Pain Assessed by Wong-Baker Faces Pain Rating Scale [Daily for 7 days after surgery]: 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.
Postoperative Analgesic Consumption [Daily for 7 days after surgery]: 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.

+Eligibility

Sex: All, ages: 18 Years to 70 Years

Inclusion Criteria:

* Systemically healthy
* Non-smoker
* Insufficient vestibular sulcus depth
* No regular medication use
* Age 18 years or older
* No previous vestibuloplasty in the same region
* Not pregnant or breastfeeding
* Willing to participate and able to provide written informed consent

Exclusion Criteria:

* Presence of a systemic disease
* Regular use of systemic medication
* Pregnancy or lactation
* Smoking or alcohol use
* Previous vestibuloplasty in the same region

+Locations (1)

Facility	City	Country	Status
İzmir Katip Çelebi University	Izmir, Çiğli	Turkey (Türkiye)	Recruiting