Effect of Guided Biofilm Therapy in Patients With Stage 3 Periodontitis

NCT07788937 | Completed

• 2 other identifiers: TDK-2023-12443ID: TDK-2023-12443
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontitis; Periodontitis (Stage 3)

Keywords

Guided Biofilm Therapy; Non-Surgical Periodontal Therapy; Diode Laser

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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.

  Baseline and 3 months

• Change in Gingival Index (GI)

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

  Baseline and 3 months

• Change in Plaque Index (PI)

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

  Baseline and 3 months

• Change in Bleeding on Probing (BOP)

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

  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).

  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).

  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).

  Baseline and 3 months

• Change in Radiographic Alveolar Bone Level

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

  Baseline and 3 months

Study Arms (3)

Conventional NSPT

ACTIVE COMPARATOR

Participants received conventional non-surgical periodontal therapy (NSPT), including full-mouth scaling and root planing using ultrasonic and hand instruments. No adjunctive treatment was administered in this group. Clinical and biochemical outcomes were evaluated during the follow-up period.

Procedure: Non-Surgical Periodontal Therapy

NSPT + Diode Laser

EXPERIMENTAL

Participants received conventional non-surgical periodontal therapy followed by adjunctive diode laser therapy according to the study protocol. Clinical periodontal parameters and inflammatory biomarkers were evaluated during follow-up.

Procedure: Non-Surgical Periodontal Therapy; Procedure: Diode Laser Therapy

NSPT + Guided Biofilm Therapy

EXPERIMENTAL

Participants received conventional non-surgical periodontal therapy combined with guided biofilm therapy (GBT) using an air-polishing system according to the study protocol. Clinical periodontal parameters and inflammatory biomarkers were evaluated during follow-up.

Procedure: Non-Surgical Periodontal Therapy; Procedure: Guided Biofilm Therapy

Interventions

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.

Conventional NSPT; NSPT + Diode Laser; NSPT + Guided Biofilm Therapy

Diode Laser Therapy PROCEDURE

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

NSPT + Diode Laser

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.

NSPT + Guided Biofilm Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Department of Periodontology, Faculty of Dentistry, Ataturk University

Erzurum, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Didem Özkal Eminoğlu

  Ataturk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants were randomly assigned to one of three parallel treatment groups: conventional non-surgical periodontal therapy (NSPT) alone, NSPT combined with adjunctive diode laser therapy, or NSPT combined with guided biofilm therapy (GBT). Each participant received only one assigned intervention throughout the study, and outcomes were compared between the three parallel groups.

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start: August 31, 2023
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: De-identified individual participant data and the supporting documents will be available beginning 6 months after publication of the primary study results and will remain available for 5 years.
• Access Criteria: Access will be provided to qualified researchers whose proposed use of the data has been approved by the study investigators. Requests must include a methodologically sound research proposal. De-identified individual participant data, the study protocol, and the statistical analysis plan will be made available upon reasonable request. Requests should be directed to the corresponding author. A data use agreement may be required before data are shared.

Locations

TU (1)