Effects of Non-Surgical Periodontal Treatment on Inflammatory and Bone Markers in Periodontitis Patients (GPNMB-PERIO St)

Saglik Bilimleri Universitesi

Status: Not yet enrolling

Conditions: Periodontitis (Stage 3)

Treatments: Procedure: Scaling and Root Planing (SRP)

Study type: Interventional

Funder types: Other

Identifiers

NCT07475013

OSATAGUN5

Details and patient eligibility

About

The goal of this study is to learn how a standard treatment called Scaling and Root Planing (SRP) affects specific biochemical markers in people with advanced gum disease (periodontitis). Periodontitis is a chronic condition that can lead to tooth loss.

The main focus is to investigate a marker called Glycoprotein Non-Metastatic B (GPNMB). This is the first study to examine GPNMB levels in both the serum and the gingival crevicular fluid of people with this condition. The study aims to answer these main questions:

How do GPNMB levels change after the Scaling and Root Planing treatment?

How does GPNMB relate to other markers that control bone health and healing, such as TGF-β1, RANKL, and Osteoprotegerin?

Researchers will compare 28 participants with advanced gum disease (Stage III Grade B/C) to 28 participants with healthy gums to see how these markers differ.

Participants in the gum disease group will:

Provide samples for laboratory analysis at the start of the study.

Receive the standard mechanical treatment of their teeth and roots (Scaling and Root Planing).

Return for follow-up visits 6 weeks and 3 months after treatment to provide new samples and have their gum health checked.

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Systemically healthy individuals
• Individuals diagnosed with Stage III Grade B or Grade C periodontitis (for the periodontitis group)
• Periodontally healthy individuals (for the healthy control group)
• Participants aged 18 years and older

Exclusion criteria

• Individuals who have received periodontal treatment within the last 6 months
• Individuals who have used antibacterial drugs within the last 6 months
• Individuals with any systemic disease
• Individuals who use medications on a regular basis
• Current smokers
• Pregnant individuals
• Participants under the age of 18 years

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Periodontitis Group

Experimental group

Description:

Participants with Stage III Grade B/C periodontitis. At baseline, clinical periodontal measurements are recorded, and serum and gingival crevicular fluid samples are collected. All participants receive non-surgical periodontal therapy consisting of Scaling and Root Planing (SRP). Follow-up visits are conducted at 6 weeks and 3 months post-treatment for repeated clinical assessments and sample collection to evaluate changes in biochemical markers (GPNMB, TGF-β1, RANKL, and OPG).

Treatment:

Procedure: Scaling and Root Planing (SRP)

Healthy Control Group

No Intervention group

Description:

Periodontally healthy individuals. Participants undergo a single clinical periodontal examination and provide serum and gingival crevicular fluid samples at the baseline visit. This group serves as a reference for baseline biochemical marker levels. No therapeutic intervention is performed.