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

NCT06490679 | Recruiting DMC

• 1 other identifier: 201123 PER 3.3.2
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Air Abrasive; Erythritol

Outcome Measures

Primary Outcomes (1)

• Change in probing pocket depth

  The PPD will be clinically measured by using UNC 15 periodontal probe from the gingival margin to the depth of the pocket.

  PPD will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.

Secondary Outcomes (9)

• Bleeding On Probing

  BoP will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.

• Clinical Attachment Level

  CAL gain will be taken at baseline, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner.

• Plaque index

  PI will be measured baseline, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner

• Calculus index

  CI will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.

• Patient pain/discomfort

  Postoperative Pain will be measured after the surgical procedure and 1 month, 3 months and 6 months after the intervention

Study Arms (2)

Hand and ultrasonic scalers and curettes

EXPERIMENTAL

Hand and ultrasonic scalers and curettes will be used for supra- and subgingival instrumentation.

Procedure: Hand and ultrasonic scalers and curettes

Electro Medical Systems AIRFLOW® Prophylaxis Master Device With Erythritol Powder

ACTIVE COMPARATOR

Prophylaxis Master Device With Erythritol Powder An erythritol powder will be used by Electro Medical Systems AIRFLOW® Prophylaxis Master Device.

Device: Electro Medical Systems AIRFLOW® Prophylaxis Master Device

Interventions

Hand and ultrasonic scalers and curettes PROCEDURE

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.

Hand and ultrasonic scalers and curettes

Electro Medical Systems AIRFLOW® Prophylaxis Master Device 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.

Electro Medical Systems AIRFLOW® Prophylaxis Master Device With Erythritol Powder

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemically healthy patients.
• Patients with an age range between 16 to 80 years.
• Patients have a minimum of 20 teeth.
• Periodontitis patients with at least one residual pocket with a probing depth ranging from 7 to 10 mm.
• Cooperative patients able and willing to come for follow up appointments.

You may not qualify if:

• Pregnant and lactation females.
• Patients reporting systemic conditions (eg: diabetes).
• Patients with severe or unstable upper respiratory tract infections, chronic bronchitis/asthma.
• Patients with severe inflammation and/or osteonecrosis.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Periodontal Pocket; Periodontitis; Gingival Diseases; Gingival Hemorrhage

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Oral Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hani El-Nahas, Professor

  Cairo University

  STUDY DIRECTOR

• Omnia Tawfik, Lecturer

  Cairo University

  STUDY CHAIR

• Mohammad Aldawod, Bachelor

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad Aldawod, Bachelor

CONTACT

00201065747906; mohammad.alaa@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Mohammad Aldawod

Study Record Dates

• First Submitted: June 29, 2024
• First Posted: July 8, 2024
• Study Start: March 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: January 1, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

EG (1)