Treatment Of Shallow Periodontal Pockets 4-6mm Using AIRFLOW Prophylaxis Master Device With Erythritol vs Manual Scalers

NCT ID: NCT06351982

Last Updated: 2024-04-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2026-01-01

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.

Detailed Description

Patients will be selected from the outpatient clinic of the Oral Medicine and Periodontology Department, Faculty of Dentistry-Cairo University

• Screening of patients will continue until the target sample is achieved. (Consecutive sampling)
• Identifying and recruiting potential subjects will be achieved through patient database.

Preoperative evaluation:

• Clinical examination

Each patient will be examined to confirm that he/she met the eligibility criteria.

Age, gender and smoking status will be collected at baseline, along with a complete periodontal charting including 6-point pocket probing depth (PPD), clinical attachment level (CAL), plaque index (PI) according to a modified O'Leary index (O'Leary et al. 1972) measured on 6 surfaces per tooth (distobuccal, buccal, mesiobuccal, distolingual, lingual and mesiolingual), Calculus index according to (Ramfjord SP. 1967).

Periapical x-rays will be taken to confirm the diagnosis of periodontitis.

• Clinical photographs Clinical photographs will be taken at baseline, immediately after treatment and 6 months after treatment.
• Radiographic examination Periapicals radiographs will be taken at the site of interest at baseline and after 3 and 6 months.
• Surgical procedure

Test sites:

1. Disclosure of biofilm with erythrosine,

2. Removal of supragingival and subgingival (up to 4 mm) biofilm and stains with the use of AIRFLOW® Master Piezon® with AIRFLOW® PLUS powder (EMS- Dental, Nyon Switzerland).

3. Supra- and sub- gingival debridement by using the AIRFLOW® Master Piezon® device with Piezon NO PAIN® (EMS-Dental) technology.

Controls will receive conventional treatment with the combination of ultrasonic and hand instrumentation only. Pockets ≥4 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.

• Postoperative: At the end of the session, the patients will receive oral hygiene instructions on manual toothbrushing and the use of interdental cleaning devices.

Conditions

Periodontal Pocket; Periodontitis; Gingival Diseases; Gingival Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Hand and ultrasonic scalers and curettes

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

Group Type: EXPERIMENTAL

Hand and ultrasonic scalers and curettes

Intervention Type: OTHER

Combination of ultrasonic and hand instrumentation only. Pockets ≥4 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.

Electro Medical Systems AIRFLOW® Prophylaxis Master Device With Erythritol Powder

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

Group Type: ACTIVE_COMPARATOR

Electro Medical Systems AIRFLOW® Prophylaxis Master Device

Intervention Type: DEVICE

1. Disclosure of biofilm with erythrosine,

2. Removal of supragingival and subgingival (up to 4 mm) biofilm and stains with the use of AIRFLOW® Master Piezon® with AIRFLOW® PLUS powder (EMS- Dental, Nyon Switzerland).

3. Supra- and sub- gingival debridement by using the AIRFLOW® Master Piezon® device with Piezon NO PAIN® (EMS-Dental) technology.

Interventions

Electro Medical Systems AIRFLOW® Prophylaxis Master Device

1. Disclosure of biofilm with erythrosine,

2. Removal of supragingival and subgingival (up to 4 mm) biofilm and stains with the use of AIRFLOW® Master Piezon® with AIRFLOW® PLUS powder (EMS- Dental, Nyon Switzerland).

3. Supra- and sub- gingival debridement by using the AIRFLOW® Master Piezon® device with Piezon NO PAIN® (EMS-Dental) technology.

Intervention Type: DEVICE

Hand and ultrasonic scalers and curettes

Combination of ultrasonic and hand instrumentation only. Pockets ≥4 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 4 to 6 mm.
• Cooperative patients able and willing to come for follow up appointments.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Asim Tariqu Al Ammour

Principal Investigator Asim Al Ammour

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hani El-Nahas, Professor

Role: STUDY_DIRECTOR

Cairo University

Omnia Tawfik, Lecturer

Role: STUDY_CHAIR

Cairo University

Asim Al Ammour, Bachelor

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Faculty of Dentistry, Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Asim Al Ammour, Bachelor

Role: CONTACT

asim.alammour@dentistry.cu.edu.eg

+201030593878

Other Identifiers

211123PER3-3-2

Identifier Type: -

Identifier Source: org_study_id