NCT06305000

Impact of Keratinized Mucosa Augmentation on Treatment Outcomes of Peri-implant Mucositis

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Biruni University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Peri-implant Mucositis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-03-27
• Primary completion: 2026-09-10
• Completion: 2026-09-10
• First posted: 2024-03-12
• Last updated: 2026-02-10

Locations

1 site across 1 country: Turkey (Türkiye)