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

Periodontitis Clinical Trial

Official title:

Evaluation Of Nonsurgical Treatment Of Shallow Periodontal Pockets (4-6mm) Using AIRFLOW® Prophylaxis Master Device With Erythritol Powder vs Conventional Instrumentation: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06351982
• Other study ID #: 211123PER3-3-2
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: April 2024
• Source: Cairo University
• Contact: Asim Al Ammour, Bachelor
• Phone: +201030593878
• Email: asim.alammour[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: January 1, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Bleeding
• Gingival Diseases
• Gingival Hemorrhage
• Periodontal Pocket
• Periodontitis

Intervention

Device:
• Electro Medical Systems AIRFLOW® Prophylaxis Master Device
Disclosure of biofilm with erythrosine, 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). Supra- and sub- gingival debridement by using the AIRFLOW® Master Piezon® device with Piezon NO PAIN® (EMS-Dental) technology.

Other:
• 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.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Bleeding On Probing	The BoP will be clinically measured by using UNC 15 periodontal probe from the CEJ to the gingival margin.	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.
Secondary	Clinical Attachment Level	The CAL will be clinically measured using UNC 15 periodontal probe from the cemento-enamel junction (CEJ) to the depth of defect.	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.
Secondary	Plaque index	The PI will be evaluated by using modified O'Leary index teeth are stained with a disclosing solution, presence of plaque is scored on a dichotomous variable and the final score per individual is the sum of the plaque scores divided by the number of surfaces examined.	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
Secondary	Calculus index	0 =absence of calculus; =supragingival calculus extending only slightly below the free gingival margin (not more than 1 mm.); = moderate amount of supra and subgingival calculus or subgingival calculus alone; = an abundance of supra and subgingival calculus	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.
Secondary	Patient pain/discomfort	Postoperative Pain will be measured by using visual analogue score (0-10)	Postoperative Pain will be measured after the surgical procedure and 1 month, 3 months and 6 months after the intervention
Secondary	Patient satisfaction	Patient satisfaction will be measured using a survey.	Patient satisfaction will be measured after the surgical procedure and 1 month, 3 months and 6 months after the intervention
Secondary	Cost effectiveness	Ratio of cost of treatment and time of procedure against the gained clinical benefit	At Baseline and 6 months post-op
Secondary	Treatment time	Time from picking-up the handpiece from the instrument holder to put the handpiece back.	Up to 6 months
Secondary	Number of healed pockets	Pocket depth of <3.5 mm clinically measured by using UNC 15 periodontal probe from the gingival margin to the depth of the pocket.	6 months post-op