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

NCT ID: NCT06726902

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-03

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Periodontitis

Keywords

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GBT Periodontitis SI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Test Group I (GBT and SI + erythritol powder)

will receive GBT and SI with adjunctive air-polishing using Standard/ Subgingival nozzle + erythritol powder

Group Type EXPERIMENTAL

GBT and SI with erythritol powder

Intervention Type DEVICE

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.

Test Group II (GBT and SI + glycine powder)

will receive GBT and SI with adjunctive air-polishing using Standard/ Subgingival nozzle + glycine powder

Group Type EXPERIMENTAL

GBT and SI with glycine powder

Intervention Type OTHER

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

Test Group III (GBT and SI + Trehalose powder)

will receive GBT and SI with adjunctive air-polishing using Standard/ Subgingival nozzle + Trehalose powder

Group Type EXPERIMENTAL

GBT and SI with trehalose powder

Intervention Type OTHER

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

Control Group VI (SRP and SI)

will receive conventional Scaling and Root planning (SRP) and (SI) without adjunctive air polishing powder

Group Type EXPERIMENTAL

SRP and SI

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DEVICE

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

Intervention Type 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

Intervention Type OTHER

SRP and SI

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

Intervention Type OTHER

Other Intervention Names

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guided biofilm therapy

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diana Ibrahim

OTHER

Sponsor Role lead

Responsible Party

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Diana Ibrahim

Periodontology MSc. Candidate

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Rania Abdelaziz Fahmy, PhD

Role: STUDY_DIRECTOR

Alexandria University

Locations

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Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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IORG 0008839-0854-01/2024

Identifier Type: -

Identifier Source: org_study_id