Periodontitis (Stage 3), Periodontitis Stage III
Conditions
Keywords
non-surgical periodontal therapy, scaling and root planning, periodontitis
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.
Interventions
PROCEDUREScaling 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.
Sponsors
Ege University Scientific Research Projects Coordination Unit
Gülnur Emingil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Single-blinded design: Outcome assessors were blinded to treatment allocation, while participants and care providers were aware of the assigned intervention.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Full-Mouth Mean Probing Depth (PD) | Baseline to 6 months | Mean change in probing depth (in millimeters) measured at six sites per tooth from baseline to 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Attachment Level (CAL) | 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). |
| Change in Bleeding on Probing (BOP) | 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. |
| Change in Plaque Index (PI) | 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. |
| 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 | 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. |
| Change in Subgingival Microbiota Composition | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed