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Enrolling by invitation NCT06726902

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

No phase Interventional Periodontitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GBT and SI with erythritol powder, GBT and SI with glycine powder, GBT and SI with trehalose powder, SRP and SI.
Who it may be relevant to
Registry conditions: Periodontitis. Basic parameters: 30 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparative Evaluation of the Effect of Different Adjunctive Air Polishing Powders in Nonsurgical Periodontal Therapy in Patients with Stage II and III Periodontitis: (A Randomized Controlled Clinical Trial)

Overview

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.

Interventions

  • Device 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 scalin
  • Other 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
  • Other 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 ro
  • Other SRP and SI
    conventional scaling and root planning (SRP) with subgingival instrumentation only will be performed

Primary outcome measures

  • Bleeding on probing [Time frame: up to six months]
  • Pain Assessment [Time frame: up to six months]
  • Probing depth [Time frame: up to six months]
  • Plaque accumulation [Time frame: up to six months]
  • Clinical attachment level [Time frame: up to six months]
  • Microbiological Assessment of Aggregatibacter actinomycetemcomitans (Aa) [Time frame: one month]
  • Microbiological Assessment of Porphyromonas gingivalis (Pg) [Time frame: one month]
  • Microbiological Assessment of Tannerella forsythia (Tf) [Time frame: one month]
  • Microbiological Assessment of Treponema denticola (Td) [Time frame: one month]

Eligibility criteria

Inclusion criteria

  • Individuals of both sexes with an age between 30 and 65 years, having at least 16 natural teeth in function,
  • Stage II and III (moderate to severe) periodontitis, having at least 16 teeth with the need for SI
  • Interproximal plaque index (API) ≤ 35%; patients with Good oral hygiene.
  • No history of systemic disease that may influence periodontal disease

Exclusion criteria

  • Pregnancy or breastfeeding,
  • Smokers with more than seven cigarettes per day
  • Patients that had a treatment with antibiotics within six months before the study
  • Need for periodontal surgery or adjunctive antibiotic treatment to the SI
  • Patients who had any periodontal treatment during the last year before the study.
  • Patients with known systemic or autoimmune disease.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Dentistry, Alexandria University — Alexandria

Identifiers

NCT: NCT06726902 · IORG 0008839-0854-01/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗