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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Diana Ibrahim

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 3, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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