Peri-implant MucositisNCT06305000
Impact of Keratinized Mucosa Augmentation on Treatment Outcomes of Peri-implant Mucositis
A study testing Non-surgical treatment and Free gingival graft in people with Peri-implant Mucositis, run by Biruni University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-implant Mucositis
- What is being tested?
- Non-surgical treatment and Free gingival graft
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Mar 2024to 10 Sep 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Biruni University
Istanbul
Ayse E Selman, +905366393184, aselman@biruni.edu.tr
About this study
Official title: Impact of Keratinized Mucosa Augmentation Following Non-surgical Therapy on Treatment Outcomes of Peri-implant Mucositis.
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?
Read more
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.
- Conditions
- Peri-implant Mucositis
- Being tested
- Non-surgical treatment, Free gingival graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical treatmentProcedure or surgery
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.
Free gingival graftProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Peri-implant healthy group with sufficient keratinized mucosa (≥ 2mm) | No intervention | Not described |
| Peri-implant mucositis group with sufficient keratinized mucosa (≥ 2mm) | Experimental | Only non-surgical therapy will apply Receives: Procedure: Non-surgical treatment |
| Peri-implant mucositis group with insufficient keratinized mucosa (< 2mm) receiving FGG | Experimental | Free gingival graft will apply following non-surgical therapy Receives: Procedure: Non-surgical treatment; Procedure: Free gingival graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 7th month
Secondary outcomes (20)
Plaque index (Silness & Löe, 1964)
0: Absence of microbial plaque
- Thin plaque layer at the mucosal margin, only detectable by scraping with a probe
- Moderate layer of plaque in the along the mucosal margin; interdental spaces free, but plaque is visible to naked eye
- Abundant plaque along with the mucosal margin; interdental places filled with plaque
Measured: Baseline (prior to therapy)
Plaque index (Silness & Löe, 1964)
Plaque index (Silness \& Löe, 1964):
0: Absence of microbial plaque
- Thin plaque layer at the mucosal margin, only detectable by scraping with a probe
- Moderate layer of plaque in the along the mucosal margin; interdental spaces free, but plaque is visible to naked eye
- Abundant plaque along with the mucosal margin; interdental places filled with plaque
Measured: 1st month
Plaque index (Silness & Löe, 1964)
0: Absence of microbial plaque
- Thin plaque layer at the mucosal margin, only detectable by scraping with a probe
- Moderate layer of plaque in the along the mucosal margin; interdental spaces free, but plaque is visible to naked eye
- Abundant plaque along with the mucosal margin; interdental places filled with plaque
Measured: 4th month
Plaque index (Silness & Löe, 1964)
0: Absence of microbial plaque
- Thin plaque layer at the mucosal margin, only detectable by scraping with a probe
- Moderate layer of plaque in the along the mucosal margin; interdental spaces free, but plaque is visible to naked eye
- Abundant plaque along with the mucosal margin; interdental places filled with plaque
Measured: 7th month
Gingival Index ( Löe & Silness,1963)
0: normal gingiva
- mild inflammation - slight change in color and slight edema but no bleeding on probing
- moderate inflammation - redness, edema and glazing, bleeding on probing
- severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding
Measured: Baseline (prior to therapy)
Gingival Index ( Löe & Silness,1963)
0: normal gingiva
- mild inflammation - slight change in color and slight edema but no bleeding on probing
- moderate inflammation - redness, edema and glazing, bleeding on probing
- severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding
Measured: 1st month
Gingival Index ( Löe & Silness,1963)
0: normal gingiva
- mild inflammation - slight change in color and slight edema but no bleeding on probing
- moderate inflammation - redness, edema and glazing, bleeding on probing
- severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding
Measured: 4th month
Gingival Index ( Löe & Silness,1963)
0: normal gingiva
- mild inflammation - slight change in color and slight edema but no bleeding on probing
- moderate inflammation - redness, edema and glazing, bleeding on probing
- severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 7th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start27 Mar 2024
- Primary completion10 Sep 2026 (estimated)
- Study completion10 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implant MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Ege SELMAN, Biruni University
- Investigators
- Ayse E Selman, Principal investigator, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305000
- Sponsor's protocol ID
- 2015-KAEK-80-23-25
- Status last verified
- Feb 2026
- First submitted
- 5 Mar 2024
- Last updated
- 10 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No