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

NCT07272980 | Completed

• 1 other identifier: 2012-DİŞ-006
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis (Stage 3); Periodontitis Stage III

Keywords

non-surgical periodontal therapy; scaling and root planning; periodontitis

Outcome Measures

Primary Outcomes (1)

• Change in Full-Mouth Mean Probing Depth (PD)

  Mean change in probing depth (in millimeters) measured at six sites per tooth from baseline to 6 months.

  Baseline to 6 months

Secondary Outcomes (5)

• Change in Clinical Attachment Level (CAL)

  Baseline, 1 month, 3 months, and 6 months after treatment

• Change in Bleeding on Probing (BOP)

  Baseline, 1 month, 3 months, 6 months

• Change in Plaque Index (PI)

  Baseline, 1 month, 3 months, 6 months

• Change in Gingival Crevicular Fluid Biomarker Levels (Clusterin, Cystatin C, IL-1β, IL-6, and Osteocalcin)

  Baseline, 1 month, 3 months, and 6 months after treatment

• Change in Subgingival Microbiota Composition

  Baseline, 1 month, 3 months, and 6 months after treatment

Study Arms (3)

Single-session non-surgical periodontal therapy

EXPERIMENTAL

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

Procedure: Scaling and Root Planing (SRP)

Three-session non-surgical periodontal therapy

EXPERIMENTAL

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

Procedure: Scaling and Root Planing (SRP)

Healthy control group

NO INTERVENTION

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

Interventions

Scaling and Root Planing (SRP) 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.

Single-session non-surgical periodontal therapy; Three-session non-surgical periodontal therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University Scientific Research Projects Coordination Unit: collaborator
• Gülnur Emingil: lead

Study Sites (1)

Istinye University, School of Dentistry

Istanbul, Turkey, 34408, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blinded design: Outcome assessors were blinded to treatment allocation, while participants and care providers were aware of the assigned intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants with Stage III/IV Grade C periodontitis were randomly assigned to one of two treatment groups: a single-session scaling and root planing (SRP) protocol or a three-session SRP protocol. Both groups received the allocated intervention in parallel and were followed for 6 months. A healthy control group was also included for comparison.

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: December 9, 2025
• Study Start: November 21, 2010
• Primary Completion: May 22, 2011
• Study Completion: May 22, 2011
• Last Updated: December 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)