Guided biofilm therapy's effect on gum tissue biomarkers in periodontitis

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

This trial will test whether guided biofilm therapy changes gingival crevicular fluid biomarkers in adults with generalized unstable periodontitis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Baghdad (Academic / other)
• Locations: 1 site (Baghdad)
• Trial ID: NCT07286916 on ClinicalTrials.gov

What this trial studies

All participants will receive the same toothpaste, toothbrush, interdental aids, and brushing instructions, and baseline full-mouth periodontal charting and radiographs will be obtained. Gingival crevicular fluid (GCF) samples will be collected at baseline and one hour later from sites allocated to either guided biofilm therapy (GBT) or control procedures. Control sites receive supragingival ultrasonic debridement initially and root surface debridement (RSD) after one week, while test sites receive the GBT protocol as the alternative non-surgical intervention. Clinical outcomes and epithelial–mesenchymal biomarkers in GCF will be compared between groups to see if GBT produces different biochemical and clinical changes than conventional care.

Who should consider this trial

Good fit: Adults over 18 with generalized unstable periodontitis (bilateral symmetric probing depths ≥4 mm and positive bleeding on probing) who are not on antibiotics or regular NSAIDs, not pregnant or breastfeeding, and able to undergo GCF sampling are the ideal candidates.

Not a fit: People without periodontitis, those currently taking antibiotics or regular NSAIDs, pregnant or breastfeeding women, patients with heavy calculus that prevents sampling, those with pulmonary disease, or anyone with an erythritol allergy are unlikely to benefit or will be excluded.

Why it matters

Potential benefit: If GBT reduces biomarkers linked to tissue breakdown it could enable less invasive or more targeted non-surgical periodontal care and improve gum health.

How similar studies have performed: Previous studies have shown GBT and erythritol air-polishing can reduce plaque and bleeding, but its specific effects on epithelial–mesenchymal biomarkers in GCF are not well established.

Eligibility criteria

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. -

Where this trial is running

Baghdad

• College of Dentistry, University of Baghdad — Baghdad, Iraq (Recruiting)

Study contacts

• Study coordinator: Ibrahim Haider Sadeq, B.D.S

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