NCT06305000 Impact of Keratinized Mucosa Augmentation on Treatment Outcomes of Peri-implant Mucositis
| NCT ID | NCT06305000 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Biruni University |
| Condition | Peri-implant Mucositis |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2024-03-27 |
| Primary Completion | 2026-09-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2024-03-27 with a primary completion date of 2026-09-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to observe the effects of keratinized mucosa width on peri-implant tissues by evaluating clinical and biochemical parameters. The main question it aims to answer is: Would increasing the width of the keratinized mucosa with free gingival graft (FGG) in peri-implant mucositis be beneficial in terms of clinical periodontal parameters and peri-implant crevicular fluid levels of inflammatory cytokines compared to non-surgical therapy alone? Our study consists of 4 groups: Peri-implant healthy group with sufficient keratinized mucosa (≥ 2mm) (n=16), peri-implant mucositis group with sufficient keratinized mucosa (n=16), peri-implant mucositis group with insufficient keratinized mucosa (\< 2mm) receiving only non-surgical treatment (n=16), peri-implant mucositis group with insufficient keratinized mucosa receiving FGG in addition to non-surgical treatment (n=16). Clinical and biochemical measurements will be recorded at the baseline, 1st month, 4th month and 7th month of the study. Peri-implant crevicular fluid samples will be collected at baseline, 1st month, 4th month and 7th month. IL-1β, RANKL, OPG levels, and RANKL/OPG ratio will be analyzed from collected samples. Researchers will evaluate the possible benefits of FGG application in addition to non-surgical therapy by comparing the biochemical and clinical changes in areas with and without FGG application in the treatment of peri-implant mucositis.
Eligibility Criteria
Inclusion Criteria: * Individual dental implants with a fixed prosthetic restoration that has been functional for at least 1 year * No systemic disease and medication use that may affect periodontal or peri-implanter tissues * Not receiving periodontal treatment in the last 6 months * Volunteering to participate in the study Exclusion Criteria: * Prosthetic restorations with an excessive contour which do not allow peri-implant pocket measurement * Being pregnant or breastfeeding, * Autoimmune and/or inflammatory diseases of the oral cavity, * Active periodontal disease * Smokers (≥ 10 cigarettes per day) * Improperly positioned implants
Contact & Investigator
Ayse E Selman
PRINCIPAL INVESTIGATOR
Biruni University
Frequently Asked Questions
Who can join the NCT06305000 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peri-implant Mucositis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06305000 currently recruiting?
Yes, NCT06305000 is actively recruiting participants. Contact the research team at aselman@biruni.edu.tr for enrollment information.
Where is the NCT06305000 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT06305000 clinical trial?
NCT06305000 is sponsored by Biruni University. The principal investigator is Ayse E Selman at Biruni University. The trial plans to enroll 48 participants.