Peri-implant Mucositis
Conditions
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.
Interventions
PROCEDURENon-surgical treatment
Non-surgical treatment consists of oral hygiene instructions, full mouth supragingival scaling using titanium hand instruments, ultrasonic devices, and subgingival debridement under local anesthesia with titanium curettes and ultrasonic instruments in a single appointment.
PROCEDUREFree gingival graft
After adequate local anesthesia is achieved. A horizontal incision is placed mucogingival junction level to prepare the recipient bed. A split-thickness flap is raised without disturbing the periosteum. FGG is obtained from the palate, extending from the mesial surface of the second premolar to the middle of the first molar. The graft is shaped and stitched on the recipient surface.
Sponsors
Biruni University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory parameter levels in peri-implant crevicular fluid | Baseline (prior to therapy) | 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
| Measure | Time frame | Description |
|---|---|---|
| Plaque index (Silness & Löe, 1964) | Baseline (prior to therapy) | 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 plaque |
| Gingival Index ( Löe & Silness,1963) | Baseline (prior to therapy) | 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 bleeding |
| Bleeding on probing (Ainamo & Bay 1975) | Baseline (prior to therapy) | 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. |
| Keratinized mucosa width | Baseline (prior to therapy) | 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. |
| Probing depth | Baseline (prior to therapy) | Probing pocket depth: 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTAyse E Selman
PRINCIPAL_INVESTIGATORAyse E Selman
Biruni University
Outcome results
None listed