An interventional study of Scaling and Root Planing (SRP) in Periodontitis (Stage 3) and Periodontitis Stage III, sponsored by Gülnur Emingil. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-15.
Sponsored by Gülnur Emingil · Not applicable, Interventional, and Treatment
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.
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.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
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Exclusion Criteria:
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)
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)
Periodontally healthy participants without clinical attachment loss or probing depths ≥4 mm were examined and sampled but received no periodontal treatment.
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.
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.
Time frame: Baseline to 6 months
Change in Clinical Attachment Level (CAL)
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).
Time frame: Baseline, 1 month, 3 months, and 6 months after treatment
Change in Bleeding on Probing (BOP)
Change in BOP (%), measured as the percentage of sites exhibiting bleeding on gentle probing, to assess gingival inflammation.
Time frame: Baseline, 1 month, 3 months, 6 months
Change in Plaque Index (PI)
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.
Time frame: Baseline, 1 month, 3 months, 6 months
Change in Gingival Crevicular Fluid Biomarker Levels (Clusterin, Cystatin C, IL-1β, IL-6, and Osteocalcin)
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.
Time frame: Baseline, 1 month, 3 months, and 6 months after treatment
Change in Subgingival Microbiota Composition
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.
Time frame: Baseline, 1 month, 3 months, and 6 months after treatment
Plan to share: No — 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.
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