About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Root surface debridement
Procedure/SurgeryControl 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
DeviceTest 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.
Treatment groups
Trial outcomes
Primary outcomes
Change in probing pocket depth (PPD)
After treatment completion PPD ≤4mm with no BOP at 4mm pockets
Secondary outcomes
Clinical attachment level (CAL)
Bleeding on probing (BOP)
Plaque index (PI)
Levels of gingival crevicular fluid (GCF) biomarkers
Sponsors and contacts
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