Evaluation Of Nonsurgical Treatment Of Deep Periodontal Pockets (7-10mm) Using AIRFLOW® Prophylaxis Master Device With Erythritol Powder vs Conventional Instrumentation

NCT06490679 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-08-09

No results posted yet for this study

Summary

Periodontitis is a chronic condition associated with the inflammatory destruction of the periodontal tissues ultimately leading to tooth loss. Clinically, it is identified by key features such as clinical attachment loss (CAL), bleeding upon probing (BOP), and an increase in probing pocket depth (PPD), and/or gingival recession. Periodontitis is mediated by polymicrobial dysbiosis with keystone pathogens affecting the virulence of the entire biofilm community. The removal of this biofilm and its retention factors is the ultimate goal of clinical treatment and oral measures applied. The elimination of the biofilm has traditionally been achieved with the use of either hand instruments or power driven devices. Promoting periodontal health or diminishing bacterial presence and calculus buildup on teeth can be accomplished with the same efficacy whether using manual scalers and curettes or ultrasonic scaling instruments. Both hand and ultrasonic instruments are characterized by being time- consuming and requiring technical skill, often causing patient discomfort and post-treatment pain, including hypersensitivity resulting from the loss of hard tissue when scaling the tooth surface. Ultrasonic instruments tend to leave a rougher surface behind compared to hand instruments. While effective the current techniques all have their disadvantages. The aim of this study is to evaluate changes in probing depth clinically, Bleeding on probing, Clinical attachment level, Plaque index, Calculus index, Patient pain/discomfort, Patient satisfaction, Cost effectiveness, Treatment time and Number of pockets closed after using AIRFLOW® Prophylaxis Master device with erythritol powder.

Conditions

  • Periodontal Pocket
  • Periodontitis
  • Gingival Diseases
  • Gingival Bleeding

Interventions

PROCEDURE

Hand and ultrasonic scalers and curettes

Combination of ultrasonic and hand instrumentation only. Pockets ≥7 mm will be subgingivally debrided using the piezo device according to manufacturer's instructions, and hand curettes will be used until the operator considers the surfaces to be sufficiently clean and free of deposits.

DEVICE

Electro Medical Systems AIRFLOW® Prophylaxis Master Device

(a) Disclosure of biofilm with erythrosine, (b) Removal of supragingival and subgingival (up to 10 mm) biofilm and stains with the use of AIRFLOW® Master Piezon® with AIRFLOW® PLUS powder (EMS-Dental, Nyon Switzerland). (c) Supra- and sub-gingival debridement by using the AIRFLOW® Master Piezon® device with Piezon NO PAIN® (EMS-Dental) technology.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Hani El-Nahas, Professor · Cairo University

  • Omnia Tawfik, Lecturer · Cairo University

  • Mohammad Aldawod, Bachelor · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2025-06-01
Completion
2026-01-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06490679 on ClinicalTrials.gov