Actively Recruiting
Impact of Keratinized Mucosa Augmentation Following Non-surgical Therapy on Treatment Outcomes of Peri-implant Mucositis
Led by Biruni University · Updated on 2026-02-10
48
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how the width of keratinized mucosa affects peri-implant tissues in people with peri-implant mucositis. The study aims to determine if increasing this mucosa width using a free gingival graft (FGG) alongside non-surgical therapy offers clinical and biochemical benefits compared to non-surgical therapy alone. The key question is whether FGG improves clinical periodontal parameters and inflammatory markers in peri-implant crevicular fluid. The study includes four groups: a healthy group with sufficient keratinized mucosa (≥ 2mm), a mucositis group with sufficient mucosa, a mucositis group with insufficient mucosa (< 2mm) receiving only non-surgical treatment, and a mucositis group with insufficient mucosa receiving both FGG and non-surgical treatment. Non-surgical therapy involves oral hygiene instructions, scaling, and subgingival cleaning in a single appointment. For those receiving FGG, the graft is taken from the palate and stitched onto the implant site after preparing the tissue. Participants will be evaluated at baseline, 1 month, 4 months, and 7 months. Researchers will collect peri-implant crevicular fluid samples and measure clinical parameters such as plaque index, gingival index, bleeding on probing, mucosa width, and probing depth at these times. Levels of inflammatory markers IL-1β, RANKL, OPG, and their ratio will be analyzed. The study monitors changes in tissue health and inflammation to assess the potential benefits of FGG with non-surgical therapy.
CONDITIONS
Brief Title
Impact of Keratinized Mucosa Augmentation on Treatment Outcomes of Peri-implant Mucositis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive oral hygiene instructions and undergo full mouth supragingival scaling and subgingival debridement in a single appointment under local anesthesia.
1 visit (in-person)
Duration - 1 day
Participants with insufficient keratinized mucosa receive a free gingival graft following non-surgical treatment involving a surgical procedure to augment keratinized mucosa.
1 visit (in-person)
Duration - 7 months
Participants attend periodic visits to assess inflammatory parameters, plaque index, gingival index, bleeding on probing, keratinized mucosa width, and probing depth after treatment.
Visits at 1 month, 4 months, and 7 months post-treatment
Trial Site Locations
Total: 1 location
1
Biruni University
Istanbul, Turkey (Türkiye)
Actively Recruiting
Research Team
A
Ayse E Selman
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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