Insufficient Vestibular Sulcus DepthNCT07767682
Effect of Oxidized Regenerated Cellulose on Vestibular Sulcus Depth After Clark Vestibuloplasty
A study testing Oxidized Regenerated Cellulose (ORC) and Periodontal Dressing in people with Insufficient Vestibular Sulcus Depth, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Insufficient Vestibular Sulcus Depth
- What is being tested?
- Oxidized Regenerated Cellulose (ORC) and Periodontal Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Apr 2026to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Presence of a systemic disease
- Regular use of systemic medication
- Pregnancy or lactation
- Smoking or alcohol use
- Previous vestibuloplasty in the same region
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İzmir Katip Çelebi University
Izmir, Çiğli, 35620
Can Berk Arığ, +90 534 060 64 57, canberkarig@gmail.com
Can Berk Arığ, Research Assistant
About this study
Official title: The Effect of Using Oxidized Regenerated Cellulose Material in Addition to the Standard Clark Vestibuloplasty Technique on Increasing Vestibular Sulcus Depth
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.
- Conditions
- Insufficient Vestibular Sulcus Depth
- Being tested
- Oxidized Regenerated Cellulose (ORC), Periodontal Dressing
- Keywords
- vestibuloplasty, Clark vestibuloplasty, oxidized regenerated cellulose, vestibular sulcus depth, keratinized gingiva
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 DressingDevice
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 group | Role | What they receive |
|---|---|---|
| Clark Vestibuloplasty + Oxidized Regenerated Cellulose | Experimental | 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. Receives: Device: Oxidized Regenerated Cellulose (ORC) |
| Standard Clark Vestibuloplasty | Active comparator | 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. Receives: Device: Periodontal Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month, and 3 months after surgery
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Daily for 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start9 Apr 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insufficient Vestibular Sulcus DepthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Can Berk Arig, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767682
- Sponsor's protocol ID
- 2026-KAE-0058
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Oxidized Regenerated Cellulose Material in Addition to the Standard Clark Vestibuloplasty Technique on Increasing Vestibular Sulcus Depth
- ClinicalTrials.gov ID
- NCT07767682
- Acronym / sponsor ID
- 2026-KAE-0058
- Conditions
- Insufficient Vestibular Sulcus Depth
- Keywords
- vestibuloplasty, Clark vestibuloplasty, oxidized regenerated cellulose, vestibular sulcus depth, keratinized gingiva
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 9 Apr 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 DressingParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Systemically healthy
- Non-smoker
- Insufficient vestibular sulcus depth
- No regular medication use
- Age 18 years or older
Key exclusion criteria (5 listed)
- Presence of a systemic disease
- Regular use of systemic medication
- Pregnancy or lactation
- Smoking or alcohol use
- Previous vestibuloplasty in the same region
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Clark Vestibuloplasty + Oxidized Regenerated Cellulose |
| Periodontal DressingPeriodontal 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. | Device | Standard Clark Vestibuloplasty |
Primary outcome
Change in Vestibular Sulcus Depth
Time frame: 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.
3 secondary outcomes
Postoperative Pain Assessed by Visual Analog Scale (VAS)
Time frame: Daily for 7 days after surgery
Postoperative Pain Assessed by Wong-Baker Faces Pain Rating Scale
Time frame: Daily for 7 days after surgery
Postoperative Analgesic Consumption
Time frame: Daily for 7 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxidized Regenerated Cellulose (ORC) and Periodontal Dressing in people with Insufficient Vestibular Sulcus Depth, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Can Berk Arığ (+90 534 060 64 57, canberkarig@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Vestibular Sulcus Depth (time frame: Baseline, 1 month, and 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.