Impact of Guided Biofilm Therapy on Epithelial and Mesenchymal Biomarkers in Periodontitis Patients

NCT07286916 | Recruiting DMC

• 1 other identifier: 1108625
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate the clinical and biochemical effects of the guided biofilm therapy protocol as an alternative to the conventional non-surgical periodontal therapy in patients with periodontitis. The main question it aims to answer is: Does the guided biofilm therapy (GBT) protocol have an impact on gingival crevicular fluid (GCF) epithelial and mesenchymal biomarkers in patients with periodontitis? All patients will be instructed to brush their teeth twice daily and will be supplied with the same type of toothpaste and toothbrush, with suitable interdental aids. All patients will be instructed to attend again after 7 days. At baseline, full-mouth periodontal charting and radiographs will be obtained and after 1-hour, GCF samples will be collected from both test and control groups. Sites allocated to control group will undergo supragingival debridement by using ultrasonic device. After one week, the control group will receive RSD using area specific (Gracey) curettes (Medesy, Italy) according to the 24-hours protocol and will receive teeth polishing by using rubber polishing cups and tooth polishing paste, while the test group will receive a full GBT protocol which includes eight steps: (1) ASSESS, (2) DISCLOSE, (3) MOTIVATE, (4) AIRFLOW, (5) PERIOFLOW, (6) PIEZON PS\*, (7) CHECK, and (8) RECALL. After finishing the treatment session, the patients will be asked to attend for follow up, clinical evaluation of PI, BOP, PPD, and CAL, and GCF samples collection after 1 month and 3 months.

Conditions

Periodontitis

Keywords

Guided biofilm therapy; Gingival crevicular fluid; Epithelial Mesenchymal Transition; Periodontitis

Outcome Measures

Primary Outcomes (1)

• Change in probing pocket depth (PPD)

  After treatment completion PPD ≤4mm with no BOP at 4mm pockets

  3 months

Secondary Outcomes (4)

• Clinical attachment level (CAL)

  3 months

• Bleeding on probing (BOP)

  3 months

• Plaque index (PI)

  3 months

• Levels of gingival crevicular fluid (GCF) biomarkers

  3 months

Study Arms (2)

Conventional non-surgical periodontal therapy (NSPT)

ACTIVE COMPARATOR

Control group

Procedure: Root surface debridement

Guided Biofilm Therapy (GBT)

EXPERIMENTAL

Test group

Device: Guided Biofilm Therapy

Interventions

Root surface debridement PROCEDURE

Control group sites that will receive conventional NSPT will undergo supragingival debridement by using ultrasonic device at baseline. After one week, sites will receive root surface debridement (RSD) using area specific (Gracey) curettes (Medesy, Italy) according to the 24-hours protocol.

Conventional non-surgical periodontal therapy (NSPT)

Guided Biofilm Therapy DEVICE

Test group sites will receive guided biofilm therapy (GBT) protocol using the Airflow Prophylaxis Master device by EMS which includes EMS DISCLOSING AGENT making the biofilm visible, EMS AIRFLOW combined with PLUS erythritol powder for removing biofilm, discoloration, and early calculus, PERIOFLOW removing the biofilm in deep periodontal pockets gently and thoroughly, and finally PIEZON PS for removing the remaining calculus.

Guided Biofilm Therapy (GBT)

Eligibility Criteria

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

You may qualify if:

• Adult subjects (\>18 years).
• Subjects are not currently under active periodontal therapy or joining other trial in the last 3 months.
• Patients must be diagnosed with generalized unstable periodontitis with bilateral, symmetrical distribution of PPD ≥ 4mm and positive BOP.

You may not qualify if:

• Patients not diagnosed with periodontitis.
• Patients consuming antibiotics.
• Regular users of nonsteroidal anti-inflammatory drugs (NSAIDs).
• Patients receiving periodontal treatment 3-months prior to the study.
• Pregnant or mothers in a breastfeeding period.
• Third molars and teeth with furcation involvement.
• Patients taking antioxidant supplements.
• Patients with heavy calculus that would prevent PerioPaper strips entrance to the periodontal pocket.
• Patient with pulmonary diseases and with a history of allergy to erythritol.
• Patients not willing to participate. -

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

College of Dentistry, University of Baghdad

Baghdad, 10047, Iraq

RECRUITING

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Ibrahim Haider Sadeq, B.D.S

CONTACT

009647722247642; Ibrahim.Ata2405@codental.uobaghdad.edu.iq

Study Design

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

Model Details: The study is a 2 arm, split-mouth, double blinded, randomized clinical trial. The first group is control group will receive conventional NSPT (scaling \& root surface debridement (RSD)), while the second group is the test group will be treated according to the GBT protocol.

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 16, 2025
• Study Start: January 4, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

IR (1)