protocolSection identificationModule nctId: NCT06305000, orgStudyIdInfo id: 2015-KAEK-80-23-25, briefTitle: Impact of Keratinized Mucosa Augmentation on Treatment Outcomes of Peri-implant Mucositis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2025-03-10, completionDateStruct date: 2025-05-10, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Biruni University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Peri-implant Mucositis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Non-surgical treatment, interventions name: Free gingival graft, outcomesModule primaryOutcomes measure: Inflammatory parameter levels in peri-implant crevicular fluid, primaryOutcomes measure: Inflammatory parameter levels in peri-implant crevicular fluid, primaryOutcomes measure: Inflammatory parameter levels in peri-implant crevicular fluid, primaryOutcomes measure: Inflammatory parameter levels in peri-implant crevicular fluid, secondaryOutcomes measure: Plaque index (Silness & Löe, 1964), secondaryOutcomes measure: Plaque index (Silness & Löe, 1964), secondaryOutcomes measure: Plaque index (Silness & Löe, 1964), secondaryOutcomes measure: Plaque index (Silness & Löe, 1964), secondaryOutcomes measure: Gingival Index ( Löe & Silness,1963), secondaryOutcomes measure: Gingival Index ( Löe & Silness,1963), secondaryOutcomes measure: Gingival Index ( Löe & Silness,1963), secondaryOutcomes measure: Gingival Index ( Löe & Silness,1963), secondaryOutcomes measure: Bleeding on probing (Ainamo & Bay 1975), secondaryOutcomes measure: Bleeding on probing (Ainamo & Bay 1975), secondaryOutcomes measure: Bleeding on probing (Ainamo & Bay 1975), secondaryOutcomes measure: Bleeding on probing (Ainamo & Bay 1975), secondaryOutcomes measure: Keratinized mucosa width, secondaryOutcomes measure: Keratinized mucosa width, secondaryOutcomes measure: Keratinized mucosa width, secondaryOutcomes measure: Keratinized mucosa width, secondaryOutcomes measure: Probing depth, secondaryOutcomes measure: Probing depth, secondaryOutcomes measure: Probing depth, secondaryOutcomes measure: Probing depth, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Biruni University, city: Istanbul, country: Turkey, contacts name: Ayse E Selman, role: CONTACT, phone: +905366393184, email: aselman@biruni.edu.tr, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False