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

NCT06726902 | Enrolling By Invitation

• 1 other identifier: IORG 0008839-0854-01/2024
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Keywords

GBT; Periodontitis; SI

Outcome Measures

Primary Outcomes (9)

• Bleeding on probing

  up to six months

• Pain Assessment

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

  up to six months

• Probing depth

  up to six months

• Plaque accumulation

  up to six months

• Clinical attachment level

  up to six months

• Microbiological Assessment of Aggregatibacter actinomycetemcomitans (Aa)

  one month

• Microbiological Assessment of Porphyromonas gingivalis (Pg)

  one month

• Microbiological Assessment of Tannerella forsythia (Tf)

  one month

• Microbiological Assessment of Treponema denticola (Td)

  one month

Study Arms (4)

Test Group I (GBT and SI + erythritol powder)

EXPERIMENTAL

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

Device: GBT and SI with erythritol powder

Test Group II (GBT and SI + glycine powder)

EXPERIMENTAL

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

Other: GBT and SI with glycine powder

Test Group III (GBT and SI + Trehalose powder)

EXPERIMENTAL

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

Other: GBT and SI with trehalose powder

Control Group VI (SRP and SI)

EXPERIMENTAL

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

Other: SRP and SI

Interventions

GBT and SI with erythritol powder 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.

Also known as: guided biofilm therapy

Test Group I (GBT and SI + erythritol powder)

GBT and SI with glycine powder 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 II (GBT and SI + glycine powder)

GBT and SI with trehalose powder 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

Test Group III (GBT and SI + Trehalose powder)

SRP and SI OTHER

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

Control Group VI (SRP and SI)

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Diana Ibrahim: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21923, Egypt

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Rania Abdelaziz Fahmy, PhD

  Alexandria University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Periodontology MSc. Candidate

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 10, 2024
• Study Start: March 3, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: six month

Locations

EG (1)