Impact of Keratinized Mucosa Augmentation on Treatment Outcomes of Peri-implant Mucositis
NCT ID: NCT06305000
Last Updated: 2025-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
64 participants
INTERVENTIONAL
2024-03-27
2025-09-10
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Peri-implant healthy group with sufficient keratinized mucosa (≥ 2mm)
No interventions assigned to this group
Peri-implant mucositis group with sufficient keratinized mucosa (≥ 2mm)
Only non-surgical therapy will apply
Non-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.
Peri-implant mucositis group with insufficient keratinized mucosa (< 2mm)
Only non-surgical therapy will apply
Non-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.
Peri-implant mucositis group with insufficient keratinized mucosa (< 2mm) receiving FGG
Free gingival graft will apply following non-surgical therapy
Non-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.
Free 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.
Interventions
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Non-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.
Free 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Being pregnant or breastfeeding,
* Autoimmune and/or inflammatory diseases of the oral cavity,
* Active periodontal disease
* Smokers (≥ 10 cigarettes per day)
* Improperly positioned implants
18 Years
ALL
Yes
Sponsors
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Biruni University
OTHER
Responsible Party
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Ayse Ege SELMAN
Principle Investigator
Principal Investigators
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Ayse E Selman
Role: PRINCIPAL_INVESTIGATOR
Biruni University
Locations
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Biruni University
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2015-KAEK-80-23-25
Identifier Type: -
Identifier Source: org_study_id
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