An interventional study of Non-surgical treatment and Free gingival graft in Peri-implant Mucositis, sponsored by Biruni University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-10.
Sponsored by Biruni University · Not applicable, Interventional, and Treatment
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.
Biruni University is the lead sponsor of 172 studies on the registry; 43 are open to participants now.
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Exclusion Criteria:
Only non-surgical therapy will apply
Procedure: Non-surgical treatment
Free gingival graft will apply following non-surgical therapy
Procedure: Non-surgical treatment · Procedure: Free gingival graft
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.
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.
Inflammatory parameter levels in peri-implant crevicular fluid
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.
Time frame: Baseline (prior to therapy)
Inflammatory parameter levels in peri-implant crevicular fluid
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.
Time frame: 1st month
Inflammatory parameter levels in peri-implant crevicular fluid
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.
Time frame: 4th month
Inflammatory parameter levels in peri-implant crevicular fluid
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.
Time frame: 7th month
Plaque index (Silness & Löe, 1964)
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
Time frame: Baseline (prior to therapy)
Plaque index (Silness & Löe, 1964)
Plaque index (Silness \& Löe, 1964): 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
Time frame: 1st month
Plaque index (Silness & Löe, 1964)
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
Time frame: 4th month
Plaque index (Silness & Löe, 1964)
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
Time frame: 7th month
Gingival Index ( Löe & Silness,1963)
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
Time frame: Baseline (prior to therapy)
Gingival Index ( Löe & Silness,1963)
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
Time frame: 1st month
Gingival Index ( Löe & Silness,1963)
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
Time frame: 4th month
Gingival Index ( Löe & Silness,1963)
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
Time frame: 7th month
Bleeding on probing (Ainamo & Bay 1975)
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.
Time frame: Baseline (prior to therapy)
Bleeding on probing (Ainamo & Bay 1975)
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.
Time frame: 1st month
Bleeding on probing (Ainamo & Bay 1975)
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.
Time frame: 4th month
Bleeding on probing (Ainamo & Bay 1975)
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.
Time frame: 7th month
Keratinized mucosa width
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.
Time frame: Baseline (prior to therapy)
Keratinized mucosa width
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.
Time frame: 1st month
Keratinized mucosa width
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.
Time frame: 4th month
Keratinized mucosa width
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.
Time frame: 7th month
Probing depth
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.
Time frame: Baseline (prior to therapy)
Probing depth
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.
Time frame: 1st month
Probing 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.
Time frame: 4th month
Probing 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.
Time frame: 7th month
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