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

University of Baghdad

Status: Not yet enrolling

Conditions: Periodontitis

Treatments: Device: Guided Biofilm Therapy; Procedure: Root surface debridement

Study type: Interventional

Funder types: Other

Identifiers

NCT07286916

1108625

Details and patient eligibility

About

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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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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. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 2 patient groups

Conventional non-surgical periodontal therapy (NSPT)

Active Comparator group

Description:

Control group

Treatment:

Procedure: Root surface debridement

Guided Biofilm Therapy (GBT)

Experimental group

Description:

Test group

Treatment:

Device: Guided Biofilm Therapy