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NCT Number: NCT07272980

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

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.

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Key information

Conditions

Periodontitis (Stage 3) Mouth Diseases Periodontal Diseases Periodontitis Periodontitis Stage III Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istinye University, School of Dentistry

Istanbul, Turkey, 34408, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Gülnur Emingil

Other

Collaborators

  • Ege University Scientific Research Projects Coordination Unit

Registry information

Acronym: TSTG

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 9, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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