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Enrolling by Invitation

NCT Number: NCT06726902

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

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, 21923, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GBT and SI with erythritol powder

Device

Non-Surgical Periodontal treatment:

  • 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 .
  • Scaling and root planing Scaling and root planing (SRP) For the control group, conventional scaling and root planning (SRP) only.

Other names: guided biofilm therapy

GBT and SI with glycine powder

Other

Non-Surgical Periodontal treatment:

  • 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.
  • 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

Other

Non-Surgical Periodontal treatment:

  • 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 .
  • Scaling and root planing Scaling and root planing (SRP) For the control group, conventional scaling and root planning (SRP) only

SRP and SI

Other

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

Primary outcomes

  1. Bleeding on probing

    Time frame: up to six months

  2. Pain Assessment

    Time frame: up to six months

    Pain level will be assed using Visual Analogue Scale (VAS) from 1 (minimum) to 10 (maximum)

  3. Probing depth

    Time frame: up to six months

  4. Plaque accumulation

    Time frame: up to six months

  5. Clinical attachment level

    Time frame: up to six months

  6. Microbiological Assessment of Aggregatibacter actinomycetemcomitans (Aa)

    Time frame: one month

  7. Microbiological Assessment of Porphyromonas gingivalis (Pg)

    Time frame: one month

  8. Microbiological Assessment of Tannerella forsythia (Tf)

    Time frame: one month

  9. Microbiological Assessment of Treponema denticola (Td)

    Time frame: one month

Sponsors and collaborators

Lead sponsor

Diana Ibrahim

Other

Registry information

Official study 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)

Acronym: GBT

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 10, 2024
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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