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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorIzmir Katip Celebi University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Systemically healthy

Non-smoker

Insufficient vestibular sulcus depth

No regular medication use

Disqualifiers

Presence of a systemic disease

Regular use of systemic medication

Pregnancy or lactation

Smoking or alcohol use

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Clark Vestibuloplasty + Oxidized Regenerated CelluloseExperimental treatment 1 intervention
Group B: Standard Clark VestibuloplastyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

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