Impact of Keratinized Mucosa Augmentation on Treatment Outcomes of Peri-implant Mucositis
ConditionPeri-implant Mucositis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBiruni University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Non-surgical treatment
Procedure/SurgeryNon-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 graft
Procedure/SurgeryAfter 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.
Treatment groups
48 Participants
are divided into 3 treatment groupsGroup A: Peri-implant healthy group with sufficient keratinized mucosa (≥ 2mm)No intervention 0 interventions
Group B: Peri-implant mucositis group with sufficient keratinized mucosa (≥ 2mm)Experimental treatment 1 intervention
Group C: Peri-implant mucositis group with insufficient keratinized mucosa (< 2mm) receiving FGGExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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)2
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 month3
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 month4
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 monthSecondary outcomes
1
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)2
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 month3
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 month4
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 monthSponsors and contacts
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Source ClinicalTrials.gov