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

Biruni University

Status: Enrolling

Conditions: Peri-implant Mucositis

Treatments: Procedure: Free gingival graft; Procedure: Non-surgical treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06305000

2015-KAEK-80-23-25

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 4 patient groups

Peri-implant healthy group with sufficient keratinized mucosa (≥ 2mm)

No Intervention group

Peri-implant mucositis group with sufficient keratinized mucosa (≥ 2mm)

Experimental group

Description:

Only non-surgical therapy will apply

Treatment:

Procedure: Non-surgical treatment

Peri-implant mucositis group with insufficient keratinized mucosa (< 2mm)

Experimental group

Description:

Only non-surgical therapy will apply

Treatment:

Procedure: Non-surgical treatment

Peri-implant mucositis group with insufficient keratinized mucosa (< 2mm) receiving FGG

Experimental group

Description:

Free gingival graft will apply following non-surgical therapy

Treatment:

Procedure: Non-surgical treatment

Procedure: Free gingival graft