Impact of Keratinized Mucosa Augmentation Following Non-surgical Therapy on Treatment Outcomes of Peri-implant Mucositis.

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Turkey
Biruni University
RECRUITING
Istanbul
Contact Information
Primary
Ayse E Selman
aselman@biruni.edu.tr
+905366393184
Time Frame
Start Date: 2024-03-27
Estimated Completion Date: 2025-09-10
Participants
Target number of participants: 64
Treatments
No_intervention: Peri-implant healthy group with sufficient keratinized mucosa (≥ 2mm)
Experimental: Peri-implant mucositis group with sufficient keratinized mucosa (≥ 2mm)
Only non-surgical therapy will apply
Experimental: Peri-implant mucositis group with insufficient keratinized mucosa (< 2mm)
Only non-surgical therapy will apply
Experimental: Peri-implant mucositis group with insufficient keratinized mucosa (< 2mm) receiving FGG
Free gingival graft will apply following non-surgical therapy
Related Therapeutic Areas
Sponsors
Leads: Biruni University

This content was sourced from clinicaltrials.gov