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

December 9, 2024 updated by: Diana Ibrahim

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)

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21923
        • Faculty of Dentistry, Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Group I (GBT and SI + erythritol powder)
will receive GBT and SI with adjunctive air-polishing using Standard/ Subgingival nozzle + erythritol powder
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 scaling and root planning (SRP) only.
Other Names:
  • guided biofilm therapy
Experimental: Test Group II (GBT and SI + glycine powder)
will receive GBT and SI with adjunctive air-polishing using Standard/ Subgingival nozzle + glycine powder
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 planning (SRP) only
Experimental: Test Group III (GBT and SI + Trehalose powder)
will receive GBT and SI with adjunctive air-polishing using Standard/ Subgingival nozzle + Trehalose powder
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 root planning (SRP) only
Experimental: Control Group VI (SRP and SI)
will receive conventional Scaling and Root planning (SRP) and (SI) without adjunctive air polishing powder
Other: SRP and SI
conventional scaling and root planning (SRP) with subgingival instrumentation only will be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding on probing
Time Frame: up to six months
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)
up to six months
Probing depth
Time Frame: up to six months
up to six months
Plaque accumulation
Time Frame: up to six months
up to six months
Clinical attachment level
Time Frame: up to six months
up to six months
Microbiological Assessment of Aggregatibacter actinomycetemcomitans (Aa)
Time Frame: one month
one month
Microbiological Assessment of Porphyromonas gingivalis (Pg)
Time Frame: one month
one month
Microbiological Assessment of Tannerella forsythia (Tf)
Time Frame: one month
one month
Microbiological Assessment of Treponema denticola (Td)
Time Frame: one month
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diana Ibrahim

Investigators

  • Study Director: Rania Abdelaziz Fahmy, PhD, Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2024

Primary Completion (Actual)

November 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

December 6, 2024

First Submitted That Met QC Criteria

December 6, 2024

First Posted (Actual)

December 10, 2024

Study Record Updates

Last Update Posted (Estimated)

December 12, 2024

Last Update Submitted That Met QC Criteria

December 9, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IORG 0008839-0854-01/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

six month

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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