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Impact of Keratinized Mucosa Augmentation on Treatment Outcomes of Peri-implant Mucositis

StatusRecruiting
PhaseNot applicable
Started2024-03-27
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 10, 2026 (before its estimated September 10, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-02-06
minor
Study Status, Study Design, Arms and Interventions v5
Primary completion date2025-09-10→2026-09-10
Completion date2025-09-10→2026-09-10
Enrollment target64→48
Study arms4→3
2025-07-07
minor
Study Status v4
Primary completion date2025-03-10→2025-09-10
Completion date2025-05-10→2025-09-10
2024-05-06
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2024-03-26
minor
Study Status v2
Start date2024-03-10→2024-03-27
2024-03-18
minor
Study Status, Sponsor/Collaborators v1
Re-verified, no change to tracked fields
2024-03-05
minor
Original filing
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.
Trial Details
NCT Number NCT06305000
Lead Sponsor Biruni University
Conditions Peri-implant Mucositis
Enrollment 48 participants
Start Date 2024-03-27
Primary Completion 2026-09-10 (estimated)
Study Completion 2026-09-10 (estimated)
Updated on ClinicalTrials.gov 2026-02-10