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Clinical Trials/NCT06726902
NCT06726902
Enrolling By Invitation
Not Applicable

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)

Diana Ibrahim1 site in 1 country56 target enrollmentMarch 3, 2024
ConditionsPeriodontitis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Periodontitis
Sponsor
Diana Ibrahim
Enrollment
56
Locations
1
Primary Endpoint
Bleeding on probing
Status
Enrolling By Invitation
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
March 3, 2024
End Date
December 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Diana Ibrahim
Responsible Party
Sponsor Investigator
Principal Investigator

Diana Ibrahim

Periodontology MSc. Candidate

Alexandria University

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.

Outcomes

Primary Outcomes

Bleeding on probing

Time Frame: up to six months

Plaque accumulation

Time Frame: up to six months

Pain Assessment

Time Frame: up to six months

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

Probing depth

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

Study Sites (1)

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