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

ConditionPeriodontitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Baghdad

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Root surface debridement

    Procedure/Surgery

    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.

Treatment groups

18 Participants
are divided into 2 treatment groups
Group A: Conventional non-surgical periodontal therapy (NSPT)Active comparator 1 intervention
Group B: Guided Biofilm Therapy (GBT)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in probing pocket depth (PPD)

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

Time frame
3 months

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

Other outcomes

Sponsors and contacts

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