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NCT Number: NCT07788937

Effect of Guided Biofilm Therapy in Patients With Stage 3 Periodontitis

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Periodontology, Faculty of Dentistry, Ataturk University

Erzurum, 25240, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults aged 18 to 65 years.
  • Diagnosis of Stage III periodontitis with clinical attachment loss (CAL) ≥5 mm, probing pocket depth (PPD) ≥6 mm, and radiographic bone loss extending to the middle or apical third of the root.
  • Systemically healthy individuals.
  • Non-smokers and non-alcohol users.
  • No periodontal treatment within the previous 6 months.
  • No history of destructive periodontal disease.
  • Not pregnant or breastfeeding.
  • Written informed consent provided.

Exclusion criteria

  • Age <18 years or >65 years.
  • Periodontitis other than Stage III.
  • Presence of systemic diseases affecting periodontal health.
  • Current smokers or alcohol users.
  • Periodontal treatment within the previous 6 months.
  • History of destructive periodontal disease.
  • Pregnancy or breastfeeding.
  • Inability or unwillingness to provide written informed consent.

Treatment and study plan

Non-surgical periodontal therapy

Procedure

Conventional non-surgical periodontal therapy consisting of full-mouth scaling and root planing performed using ultrasonic and hand instruments according to the study protocol.

Diode Laser Therapy

Procedure

Adjunctive diode laser therapy administered following conventional non-surgical periodontal therapy according to the study protocol.

Guided Biofilm Therapy

Procedure

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.

Primary outcomes

  1. Change in Clinical Attachment Level (CAL)

    Time frame: Baseline and 3 months

    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.

  2. Change in IL-1β Levels in Gingival Crevicular Fluid

    Time frame: Baseline and 3 months

    Change in gingival crevicular fluid IL-1β concentrations measured by ELISA from baseline to 3 months.

  3. Change in Probing Pocket Depth (PPD)

    Time frame: Baseline and 3 months

    Change in probing pocket depth (PPD, mm) measured using a periodontal probe at six sites per tooth.

  4. Change in Gingival Index (GI)

    Time frame: Baseline and 3 months

    Change in gingival inflammation assessed using the Gingival Index (GI).

  5. Change in Plaque Index (PI)

    Time frame: Baseline and 3 months

    Change in dental plaque accumulation assessed using the Plaque Index (PI).

  6. Change in Bleeding on Probing (BOP)

    Time frame: Baseline and 3 months

    Change in bleeding on probing (BOP) assessed during periodontal examination.

  7. Change in Gingival Crevicular Fluid IL-1 Receptor Antagonist (IL-1RA) Levels

    Time frame: Baseline and 3 months

    Change in gingival crevicular fluid IL-1 receptor antagonist (IL-1RA) concentrations measured using enzyme-linked immunosorbent assay (ELISA).

  8. Change in Gingival Crevicular Fluid Sclerostin Levels

    Time frame: Baseline and 3 months

    Change in gingival crevicular fluid sclerostin concentrations measured using enzyme-linked immunosorbent assay (ELISA).

  9. Change in Gingival Crevicular Fluid Transforming Growth Factor-β1 (TGF-β1) Levels

    Time frame: Baseline and 3 months

    Change in gingival crevicular fluid transforming growth factor-beta 1 (TGF-β1) concentrations measured using enzyme-linked immunosorbent assay (ELISA).

  10. Change in Radiographic Alveolar Bone Level

    Time frame: Baseline and 3 months

    Change in radiographic alveolar bone level assessed using standardized periapical radiographs.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

The Effect of Guided Biofilm Therapy and Adjunctive Diode Laser on Periodontal Inflammation and Alveolar Bone Destruction in Patients With Stage 3 Periodontitis

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 27, 2026
Registry last updated
Aug 27, 2026

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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