This randomized interventional study aims to compare the clinical and biochemical effects of conventional non-surgical periodontal therapy (NSPT), adjunctive diode laser therapy, and guided biofilm therapy (GBT) in patients with Stage 3 periodontitis. Participants are allocated to one of three treatment groups: conventional NSPT alone, NSPT combined with diode laser therapy, or NSPT combined with guided biofilm therapy. Clinical periodontal parameters, including plaque index, gingival index, probing pocket depth, clinical attachment level, and bleeding on probing, are evaluated before treatment and during follow-up. In addition, serum and gingival crevicular fluid samples are collected to determine the levels of inflammatory biomarkers, including IL-1β, IL-1 receptor antagonist (IL-1RA), sclerostin, and transforming growth factor-beta 1 (TGF-β1). The study evaluates whether adjunctive treatment modalities provide additional clinical and biological benefits compared with conventional non-surgical periodontal therapy alone.
Periodontitis is a chronic inflammatory disease characterized by the destruction of periodontal supporting tissues. Conventional non-surgical periodontal therapy (NSPT) is considered the standard treatment; however, adjunctive treatment approaches have been introduced to improve clinical outcomes and reduce inflammation. Guided biofilm therapy (GBT) is a minimally invasive treatment protocol that combines biofilm visualization, air-polishing, and selective calculus removal. Diode laser therapy has also been proposed as an adjunctive treatment because of its antimicrobial, anti-inflammatory, and biostimulatory effects. The purpose of this randomized clinical study is to compare the effects of conventional NSPT alone, NSPT combined with diode laser therapy, and NSPT combined with GBT in patients diagnosed with Stage 3 periodontitis. Participants are randomly assigned to one of three parallel treatment groups. Clinical periodontal parameters are recorded at baseline and during follow-up. Gingival crevicular fluid and serum samples are collected for biochemical analysis. The concentrations of IL-1β, IL-1 receptor antagonist (IL-1RA), sclerostin, and transforming growth factor-beta 1 (TGF-β1) are measured using enzyme-linked immunosorbent assay (ELISA). The primary objective is to compare the effects of the three treatment protocols on periodontal inflammation and clinical periodontal outcomes. Secondary objectives include evaluating changes in inflammatory biomarker levels in serum and gingival crevicular fluid and investigating the potential biological mechanisms associated with each treatment modality. The findings of this study are expected to contribute to the evidence regarding adjunctive treatment approaches for Stage 3 periodontitis and improve understanding of the biological effects of guided biofilm therapy and diode laser therapy in periodontal treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Conventional non-surgical periodontal therapy consisting of full-mouth scaling and root planing performed using ultrasonic and hand instruments according to the study protocol.
Adjunctive diode laser therapy administered following conventional non-surgical periodontal therapy according to the study protocol.
Guided biofilm therapy performed using an erythritol powder air-polishing system as an adjunct to conventional non-surgical periodontal therapy according to the study protocol.
Department of Periodontology, Faculty of Dentistry, Ataturk University
Erzurum, Turkey (Türkiye)
Change in Clinical Attachment Level (CAL)
Change in clinical attachment level (CAL, mm) from baseline to 3 months after treatment. CAL was measured using a periodontal probe at six sites per tooth.
Time frame: Baseline and 3 months
Change in IL-1β Levels in Gingival Crevicular Fluid
Change in gingival crevicular fluid IL-1β concentrations measured by ELISA from baseline to 3 months.
Time frame: Baseline and 3 months
Change in Probing Pocket Depth (PPD)
Change in probing pocket depth (PPD, mm) measured using a periodontal probe at six sites per tooth.
Time frame: Baseline and 3 months
Change in Gingival Index (GI)
Change in gingival inflammation assessed using the Gingival Index (GI).
Time frame: Baseline and 3 months
Change in Plaque Index (PI)
Change in dental plaque accumulation assessed using the Plaque Index (PI).
Time frame: Baseline and 3 months
Change in Bleeding on Probing (BOP)
Change in bleeding on probing (BOP) assessed during periodontal examination.
Time frame: Baseline and 3 months
Change in Gingival Crevicular Fluid IL-1 Receptor Antagonist (IL-1RA) Levels
Change in gingival crevicular fluid IL-1 receptor antagonist (IL-1RA) concentrations measured using enzyme-linked immunosorbent assay (ELISA).
Time frame: Baseline and 3 months
Change in Gingival Crevicular Fluid Sclerostin Levels
Change in gingival crevicular fluid sclerostin concentrations measured using enzyme-linked immunosorbent assay (ELISA).
Time frame: Baseline and 3 months
Change in Gingival Crevicular Fluid Transforming Growth Factor-β1 (TGF-β1) Levels
Change in gingival crevicular fluid transforming growth factor-beta 1 (TGF-β1) concentrations measured using enzyme-linked immunosorbent assay (ELISA).
Time frame: Baseline and 3 months
Change in Radiographic Alveolar Bone Level
Change in radiographic alveolar bone level assessed using standardized periapical radiographs.
Time frame: Baseline and 3 months
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