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

February 24, 2026 updated by: Ibrahim Haider Sadeq, University of Baghdad

Impact of Guided Biofilm Therapy on Gingival Crevicular Fluid Epithelial and Mesenchymal Biomarkers in Periodontitis Patients: A Randomized Controlled Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Iraq
      • Baghdad, Iraq, 10047
        • Recruiting
        • College of Dentistry, University of Baghdad
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adult subjects (>18 years).
  2. Subjects are not currently under active periodontal therapy or joining other trial in the last 3 months.

  3. Patients must be diagnosed with generalized unstable periodontitis with bilateral, symmetrical distribution of PPD ≥ 4mm and positive BOP.

    -

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional non-surgical periodontal therapy (NSPT)
Control group
Procedure: Root surface debridement
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.
Experimental: Guided Biofilm Therapy (GBT)
Test group
Device: Guided Biofilm Therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in probing pocket depth (PPD)
Time Frame: 3 months
After treatment completion PPD ≤4mm with no BOP at 4mm pockets
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical attachment level (CAL)
Time Frame: 3 months
3 months
Bleeding on probing (BOP)
Time Frame: 3 months
3 months
Plaque index (PI)
Time Frame: 3 months
3 months
Levels of gingival crevicular fluid (GCF) biomarkers
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Baghdad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

December 1, 2025

First Submitted That Met QC Criteria

December 13, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1108625

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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