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

D

Diana Ibrahim

Status

Invitation-only

Conditions

Periodontitis

Treatments

Other: SRP and SI
Other: GBT and SI with glycine powder
Other: GBT and SI with trehalose powder
Device: GBT and SI with erythritol powder

Study type

Interventional

Funder types

Other

Identifiers

NCT06726902
IORG 0008839-0854-01/2024

Details and patient eligibility

About

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.

Enrollment

56 estimated patients

Sex

All

Ages

30 to 65 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

56 participants in 4 patient groups

Test Group I (GBT and SI + erythritol powder)
Experimental group
Description:
will receive GBT and SI with adjunctive air-polishing using Standard/ Subgingival nozzle + erythritol powder
Treatment:
Device: GBT and SI with erythritol powder
Test Group II (GBT and SI + glycine powder)
Experimental group
Description:
will receive GBT and SI with adjunctive air-polishing using Standard/ Subgingival nozzle + glycine powder
Treatment:
Other: GBT and SI with glycine powder
Test Group III (GBT and SI + Trehalose powder)
Experimental group
Description:
will receive GBT and SI with adjunctive air-polishing using Standard/ Subgingival nozzle + Trehalose powder
Treatment:
Other: GBT and SI with trehalose powder
Control Group VI (SRP and SI)
Experimental group
Description:
will receive conventional Scaling and Root planning (SRP) and (SI) without adjunctive air polishing powder
Treatment:
Other: SRP and SI

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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