Comparative Evaluation of the Effect of Different Adjunctive Air Polishing Powders in Nonsurgical Periodontal Therapy in Patients with Stage II and III Periodontitis

NCT06726902 · tracked via the Priya Life Science Egypt tracker

Sponsor

Diana Ibrahim

Phase

Not applicable

Started

2024-03-03

Last updated

2024-12-12

Condition(s) studied

Periodontitis

Investigational drug(s) / intervention(s)

GBT and SI with erythritol powderGBT and SI with glycine powderGBT and SI with trehalose powderSRP and SI

GBT and SI with erythritol powder: Non-Surgical Periodontal treatment: 1. Guided Biofilm Therapy * Guided supragingival and shallow subgingival (PD ≥ 4 mm) removal of biofilm and stains from all quadrants using the air-polishing device using a standard nozzle system. * Subgingival removal of biofilm from deeper periodontal pockets (PD ≥ 6 mm) using an Air-polishing device subgingival nozzle system with erythritol powder . 2. Scaling and root planing Scaling and root planing (SRP) For the control group, conventional scaling and root planning (SRP) only.

GBT and SI with glycine powder: Non-Surgical Periodontal treatment: 1. Guided Biofilm Therapy • Guided supragingival and shallow subgingival (PD ≥ 4 mm) removal of biofilm and stains from all quadrants using the air-polishing device using a standard nozzle system. • Subgingival removal of biofilm from deeper periodontal pockets (PD ≥ 6 mm) using an Air-polishing device subgingival nozzle system with glycine powder. 2. Scaling and root planing Scaling and root planing (SRP) For the control group, conventional scaling and root planning (SRP) only

GBT and SI with trehalose powder: Non-Surgical Periodontal treatment: 1. Guided Biofilm Therapy • Guided supragingival and shallow subgingival (PD ≥ 4 mm) removal of biofilm and stains from all quadrants using the air-polishing device using a standard nozzle system. • Subgingival removal of biofilm from deeper periodontal pockets (PD ≥ 6 mm) using an Air-polishing device subgingival nozzle system with trehalose powder . 2. Scaling and root planing Scaling and root planing (SRP) For the control group, conventional scaling and root planning (SRP) only

SRP and SI: conventional scaling and root planning (SRP) with subgingival instrumentation only will be performed

Study summary

The aim of this clinical trial is to evaluate and compare the effect of a newly designed air-polishing device (APD) using Erythritol, Glycine, and Trehalose air-polishing powders in nonsurgical periodontal therapy with control (conventional scaling and root planning) following the concept of guided biofilm therapy (GBT) as an adjunctive to subgingival instrumentation (SI) in nonsurgical periodontal therapy for Stage II and III periodontitis patients both clinically and microbiologically.

Eligibility

Sex

ALL

Min age

30 Years

Max age

65 Years

Healthy volunteers

Inclusion Criteria: 1. Individuals of both sexes with an age between 30 and 65 years, having at least 16 natural teeth in function, 2. Stage II and III (moderate to severe) periodontitis, having at least 16 teeth with the need for SI 3. Interproximal plaque index (API) ≤ 35%; patients with Good oral hygiene. 4. No history of systemic disease that may influence periodontal disease Exclusion Criteria: 1. Pregnancy or breastfeeding, 2. Smokers with more than seven cigarettes per day 3. Patients that had a treatment with antibiotics within six months before the study 4. Need for periodontal surgery or adjunctive antibiotic treatment to the SI 5. Patients who had any periodontal treatment during the last year before the study. 6. Patients with known systemic or autoimmune disease.

Primary outcome measure(s)

Bleeding on probing — up to six months
Pain Assessment — up to six months
Pain level will be assed using Visual Analogue Scale (VAS) from 1 (minimum) to 10 (maximum)
Probing depth — up to six months
Plaque accumulation — up to six months
Clinical attachment level — up to six months
Microbiological Assessment of Aggregatibacter actinomycetemcomitans (Aa) — one month
Microbiological Assessment of Porphyromonas gingivalis (Pg) — one month
Microbiological Assessment of Tannerella forsythia (Tf) — one month
Microbiological Assessment of Treponema denticola (Td) — one month

Trial sites (1)

Facility	City	Region	Status
Faculty of Dentistry, Alexandria University	Alexandria	Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06726902 on ClinicalTrials.gov ↗ ← All trials in Egypt