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

Cairo University (CU)

Status: Enrolling

Conditions: Periodontitis; Gingival Bleeding; Periodontal Pocket; Gingival Diseases

Treatments: Device: Electro Medical Systems AIRFLOW® Prophylaxis Master Device; Procedure: Hand and ultrasonic scalers and curettes

Study type: Interventional

Funder types: Other

Identifiers

NCT06490679

201123 PER 3.3.2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 estimated patients

Sex: All

Ages: 16 to 80 years old

Volunteers: Accepts Healthy Volunteers

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 7 to 10 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups

Hand and ultrasonic scalers and curettes

Experimental group

Description:

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

Treatment:

Procedure: Hand and ultrasonic scalers and curettes

Electro Medical Systems AIRFLOW® Prophylaxis Master Device With Erythritol Powder

Active Comparator group

Description:

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

Treatment:

Device: Electro Medical Systems AIRFLOW® Prophylaxis Master Device