Insufficient Vestibular Sulcus Depth
Conditions
Keywords
vestibuloplasty, Clark vestibuloplasty, oxidized regenerated cellulose, vestibular sulcus depth, keratinized gingiva
Brief 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.
Interventions
DEVICEOxidized 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.
DEVICEPeriodontal 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
Izmir Katip Celebi University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessor performing the photographic analysis and linear measurements is blinded to participant group allocation.
Intervention model description
Two-arm, randomized, controlled, parallel-group clinical trial. Participants will be randomized using the envelope method to receive either standard Clark vestibuloplasty with oxidized regenerated cellulose (Reoxcel Sigma Knit) or standard Clark vestibuloplasty with periodontal dressing.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTCan Berk Arığ
Outcome results
None listed