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

December 11, 2025 updated by: Gülnur Emingil
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Turkey
      • Istanbul, Turkey, Turkey (Türkiye), 34408
        • Istinye University, School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: 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.
Experimental: 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.
Procedure: 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.
No Intervention: Healthy control group
Periodontally healthy participants without clinical attachment loss or probing depths ≥4 mm were examined and sampled but received no periodontal treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Full-Mouth Mean Probing Depth (PD)
Time Frame: Baseline to 6 months
Mean change in probing depth (in millimeters) measured at six sites per tooth from baseline to 6 months.
Baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Clinical Attachment Level (CAL)
Time Frame: Baseline, 1 month, 3 months, and 6 months after treatment
Evaluation of changes in CAL (mm) at six sites per tooth to assess periodontal healing and inflammation following single-session versus three-session scaling and root planing (SRP).
Baseline, 1 month, 3 months, and 6 months after treatment
Change in Bleeding on Probing (BOP)
Time Frame: Baseline, 1 month, 3 months, 6 months
Change in BOP (%), measured as the percentage of sites exhibiting bleeding on gentle probing, to assess gingival inflammation.
Baseline, 1 month, 3 months, 6 months
Change in Plaque Index (PI)
Time Frame: Baseline, 1 month, 3 months, 6 months
Change in PI to evaluate supragingival plaque levels, assessed as the percentage of tooth surfaces with visible supragingival plaque, to evaluate the level of supragingival biofilm accumulation.
Baseline, 1 month, 3 months, 6 months
Change in Gingival Crevicular Fluid Biomarker Levels (Clusterin, Cystatin C, IL-1β, IL-6, and Osteocalcin)
Time Frame: Baseline, 1 month, 3 months, and 6 months after treatment
GCF samples collected from sites with PD ≥ 5 mm will be analyzed using multiplex immunoassay to determine changes in host-response biomarkers reflecting tissue inflammation and repair.
Baseline, 1 month, 3 months, and 6 months after treatment
Change in Subgingival Microbiota Composition
Time Frame: Baseline, 1 month, 3 months, and 6 months after treatment
Quantitative and qualitative assessment of periodontal pathogens (e.g., A. actinomycetemcomitans, P. gingivalis, T. denticola, T. forsythia, F. nucleatum) via DNA-DNA checkerboard hybridization to evaluate microbiological effects of SRP regimens.
Baseline, 1 month, 3 months, and 6 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gülnur Emingil

Collaborators

Ege University Scientific Research Projects Coordination Unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2010

Primary Completion (Actual)

May 22, 2011

Study Completion (Actual)

May 22, 2011

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

December 8, 2025

First Posted (Estimated)

December 9, 2025

Study Record Updates

Last Update Posted (Actual)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-DİŞ-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The individual participant data (IPD) underlying this article will not be shared because anonymized patient-level data were analyzed only in aggregate form, and no separate data repository was created for public access. Summary results are fully presented in the published article.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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