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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peri-implant healthy group with sufficient keratinized mucosa (≥ 2mm) | No Intervention | ||
| Peri-implant mucositis group with sufficient keratinized mucosa (≥ 2mm) | Experimental | Only non-surgical therapy will apply |
|
| Peri-implant mucositis group with insufficient keratinized mucosa (< 2mm) receiving FGG | Experimental | Free gingival graft will apply following non-surgical therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-surgical treatment | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 7th month |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque index (Silness & Löe, 1964) | 0: Absence of microbial plaque
| Baseline (prior to therapy) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ayse E Selman | Contact | +905366393184 | aselman@biruni.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Ayse E Selman | Biruni University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biruni University | Recruiting | Istanbul | Turkey (Türkiye) |
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| Free gingival graft | Procedure | 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. |
|
| Plaque index (Silness & Löe, 1964) | Plaque index (Silness & Löe, 1964): 0: Absence of microbial plaque
| 1st month |
| Plaque index (Silness & Löe, 1964) | 0: Absence of microbial plaque
| 4th month |
| Plaque index (Silness & Löe, 1964) | 0: Absence of microbial plaque
| 7th month |
| Gingival Index ( Löe & Silness,1963) | 0: normal gingiva
| Baseline (prior to therapy) |
| Gingival Index ( Löe & Silness,1963) | 0: normal gingiva
| 1st month |
| Gingival Index ( Löe & Silness,1963) | 0: normal gingiva
| 4th month |
| Gingival Index ( Löe & Silness,1963) | 0: normal gingiva
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 7th month |