Three-Session Non-Surgical Periodontal Therapy Improves Biochemical and Microbiological Profiles in Patients With Severe Grade C Periodontitis

NCT ID: NCT07272980

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-21
• Study Completion Date: 2011-05-22

Brief Summary

This clinical study investigates two different non-surgical periodontal therapy approaches in patients with advanced periodontitis and compares them with periodontally healthy individuals. Participants with Stage III/IV Grade C periodontitis are randomly assigned to either a single-session or a three-session scaling and root planing (SRP) protocol. Clinical parameters, gingival crevicular fluid inflammatory markers, and subgingival microbial profiles are assessed at baseline and during a 6-month follow-up period. The study aims to determine whether performing non-surgical periodontal therapy in multiple sessions influences clinical, biochemical, and microbiological responses.

Detailed Description

This randomized, single-blinded, controlled clinical trial is conducted at the Department of Periodontology, School of Dentistry, Ege University, İzmir, Turkey. The purpose of the study is to evaluate whether a three-session non-surgical periodontal therapy protocol provides different clinical, biochemical, and microbiological responses compared to a single-session protocol in patients with Stage III/IV Grade C periodontitis.

Participants with periodontitis are randomly assigned to one of two intervention groups:

Single-Session Therapy Group (SSTG): full-mouth scaling and root planing (SRP) performed in one visit.

Three-Session Therapy Group (TSTG): quadrant-wise SRP delivered over three sessions within the same week.

All procedures are carried out by a single calibrated clinician. Clinical periodontal parameters-probing depth, clinical attachment level, plaque index, and bleeding on probing-are recorded at baseline and at predetermined follow-up visits at 1, 3, and 6 months.

Gingival crevicular fluid samples are collected to quantify inflammatory biomarkers, including interleukin-1β (IL-1β), interleukin-6 (IL-6), clusterin, cystatin C, and osteocalcin, using multiplex immunoassays. Subgingival microbial profiles are evaluated using checkerboard DNA-DNA hybridization targeting a panel of selected bacterial species.

The study protocol has received ethics approval from the Ege University School of Medicine Ethics Committee, and written informed consent is obtained from all participants. The research is supported by the Scientific Research Projects Coordination Unit of Ege University.

Conditions

Periodontitis (Stage 3); Periodontitis Stage III

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Three-session non-surgical periodontal therapy

Participants received full-mouth scaling and root planing (SRP) over three consecutive weekly sessions under local anesthesia. Standard oral hygiene instructions were provided.

Group Type: EXPERIMENTAL

Scaling and Root Planing (SRP)

Intervention Type: PROCEDURE

Full-mouth scaling and root planing (SRP) performed under local anesthesia, either in a single session or divided into three weekly sessions depending on the study arm. Standard oral hygiene instructions were provided to all participants.

Healthy control group

Periodontally healthy participants without clinical attachment loss or probing depths ≥4 mm were examined and sampled but received no periodontal treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Single-session non-surgical periodontal therapy

Participants received full-mouth scaling and root planing (SRP) completed in a single session under local anesthesia. Standard oral hygiene instructions were provided.

Group Type: EXPERIMENTAL

Scaling and Root Planing (SRP)

Intervention Type: PROCEDURE

Full-mouth scaling and root planing (SRP) performed under local anesthesia, either in a single session or divided into three weekly sessions depending on the study arm. Standard oral hygiene instructions were provided to all participants.

Interventions

Scaling and Root Planing (SRP)

Full-mouth scaling and root planing (SRP) performed under local anesthesia, either in a single session or divided into three weekly sessions depending on the study arm. Standard oral hygiene instructions were provided to all participants.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Systemically healthy, non-smoking individuals aged 18-65 years
• Diagnosis of Stage III or IV Grade C periodontitis according to the 2018 classification of periodontal diseases
• Presence of at least 20 teeth
• No periodontal treatment within the previous 6 months
• Willingness to participate and provide written informed consent

Exclusion Criteria

• Presence of systemic diseases or conditions affecting the periodontium (e.g., diabetes mellitus, cardiovascular diseases, immunological disorders)
• Pregnancy or lactation
• Use of antibiotics, anti-inflammatory, or immunosuppressive drugs within the past 3 months
• History of periodontal therapy or surgery within the last 6 months
• Smoking or use of any tobacco products

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ege University Scientific Research Projects Coordination Unit

UNKNOWN

Sponsor Role: collaborator

Gülnur Emingil

OTHER

Sponsor Role: lead

Responsible Party

Gülnur Emingil

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Istinye University, School of Dentistry

Istanbul, Turkey, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2012-DİŞ-006

Identifier Type: -

Identifier Source: org_study_id