Impact of Keratinized Mucosa Augmentation on Treatment Outcomes of Peri-implant Mucositis
- Conditions
- Peri-implant Mucositis
- Interventions
- Procedure: Non-surgical treatmentProcedure: Free gingival graft
- Registration Number
- NCT06305000
- Lead Sponsor
- Biruni University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 64
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Peri-implant mucositis group with sufficient keratinized mucosa (≥ 2mm) Non-surgical treatment Only non-surgical therapy will apply Peri-implant mucositis group with insufficient keratinized mucosa (< 2mm) Non-surgical treatment Only non-surgical therapy will apply Peri-implant mucositis group with insufficient keratinized mucosa (< 2mm) receiving FGG Non-surgical treatment Free gingival graft will apply following non-surgical therapy Peri-implant mucositis group with insufficient keratinized mucosa (< 2mm) receiving FGG Free gingival graft Free gingival graft will apply following non-surgical therapy
- Primary Outcome Measures
Name Time Method Inflammatory parameter levels in peri-implant crevicular fluid 7th month Peri-implant crevicular fluid samples will be collected from 3 sites (mesiobuccal, buccal, distobuccal) of the implants using methylcellulose strips PerioPaper® (Oralflow Inc., Smithtown, NY, USA) gently placed into the cleansed and dried pocket for 30 sec. Interleukin-1beta, RANKL and OPG levels and RANKL/ OPG ratio will be evaluated.
- Secondary Outcome Measures
Name Time Method Plaque index (Silness & Löe, 1964) 7th month 0: Absence of microbial plaque
1. Thin plaque layer at the mucosal margin, only detectable by scraping with a probe
2. Moderate layer of plaque in the along the mucosal margin; interdental spaces free, but plaque is visible to naked eye
3. Abundant plaque along with the mucosal margin; interdental places filled with plaqueProbing depth 7th month The distance from the base of the pocket to the mucosal margin. Measurements will be made at six points on all teeth/ implants (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe.
Bleeding on probing (Ainamo & Bay 1975) 7th month Bleeding on probing A bleeding-on-probing percentage score assessed as the proportion of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized manual probe with a controlled (\~25 g) force to the bottom of the sulcus/pocket at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) on all present teeth/ implants.
Gingival Index ( Löe & Silness,1963) 7th month 0: normal gingiva
1. mild inflammation - slight change in color and slight edema but no bleeding on probing
2. moderate inflammation - redness, edema and glazing, bleeding on probing
3. severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleedingKeratinized mucosa width 7th month The apical-coronal distance from the mucosal margin to the mucogingival junction (MGJ). Measurements will be made at three points on implants (mesiobuccal, midbuccal, distobuccal) using a periodontal probe.
Trial Locations
- Locations (1)
Biruni University
🇹🇷Istanbul, Turkey