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NCT Number: NCT07286916

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

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

College of Dentistry, University of Baghdad

Baghdad, 10047, Iraq

Location status: Recruiting

Location contact

College of Dentistry, University of Baghdad

CONTACT

[email protected]

0096414169394

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

-

Exclusion criteria

  • 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. -

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in probing pocket depth (PPD)

    Time frame: 3 months

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

Secondary outcomes

  1. Clinical attachment level (CAL)

    Time frame: 3 months

  2. Bleeding on probing (BOP)

    Time frame: 3 months

  3. Plaque index (PI)

    Time frame: 3 months

  4. Levels of gingival crevicular fluid (GCF) biomarkers

    Time frame: 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Ibrahim Haider Sadeq, B.D.S

CONTACT

[email protected]

009647722247642

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2025
Registry last updated
Feb 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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