Impact of Keratinized Mucosa Augmentation on Treatment Outcomes of Peri-implant Mucositis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-surgical treatment, Free gingival graft.
- Who it may be relevant to
- Registry conditions: Peri-implant Mucositis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Keratinized Mucosa Augmentation Following Non-surgical Therapy on Treatment Outcomes of Peri-implant Mucositis.
Overview
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.
Interventions
- Procedure 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. - Procedure 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.
Primary outcome measures
- Inflammatory parameter levels in peri-implant crevicular fluid [Time frame: Baseline (prior to therapy)]
- Inflammatory parameter levels in peri-implant crevicular fluid [Time frame: 1st month]
- Inflammatory parameter levels in peri-implant crevicular fluid [Time frame: 4th month]
- Inflammatory parameter levels in peri-implant crevicular fluid [Time frame: 7th month]
Secondary outcome measures (12)
- Plaque index (Silness & Löe, 1964) [Time frame: Baseline (prior to therapy)]
- Plaque index (Silness & Löe, 1964) [Time frame: 1st month]
- Plaque index (Silness & Löe, 1964) [Time frame: 4th month]
- Plaque index (Silness & Löe, 1964) [Time frame: 7th month]
- Gingival Index ( Löe & Silness,1963) [Time frame: Baseline (prior to therapy)]
- Gingival Index ( Löe & Silness,1963) [Time frame: 1st month]
- Gingival Index ( Löe & Silness,1963) [Time frame: 4th month]
- Gingival Index ( Löe & Silness,1963) [Time frame: 7th month]
- Bleeding on probing (Ainamo & Bay 1975) [Time frame: Baseline (prior to therapy)]
- Bleeding on probing (Ainamo & Bay 1975) [Time frame: 1st month]
- Bleeding on probing (Ainamo & Bay 1975) [Time frame: 4th month]
- Bleeding on probing (Ainamo & Bay 1975) [Time frame: 7th month]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Biruni University — Istanbul
Identifiers
NCT: NCT06305000 · 2015-KAEK-80-23-25