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

Not Applicable

Recruiting

• Conditions: Periodontal Pocket; Periodontitis; Gingival Diseases; Gingival Bleeding
• Interventions: Procedure: Hand and ultrasonic scalers and curettes; Device: Electro Medical Systems AIRFLOW® Prophylaxis Master Device

• Registration Number: NCT06490679
• Lead Sponsor: Cairo University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-03-01
• Study First Submitted: 2024-06-29
• Study First Submitted QC: 2024-06-29
• Study First Posted: 2024-07-08
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09
• Primary Completion: 2025-06-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hand and ultrasonic scalers and curettes	Hand and ultrasonic scalers and curettes	Hand and ultrasonic scalers and curettes will be used for supra- and subgingival instrumentation.
Electro Medical Systems AIRFLOW® Prophylaxis Master Device With Erythritol Powder	Electro Medical Systems AIRFLOW® Prophylaxis Master Device	Prophylaxis Master Device With Erythritol Powder An erythritol powder will be used by Electro Medical Systems AIRFLOW® Prophylaxis Master Device.

Primary Outcome Measures

Name	Time	Method
Change in probing pocket depth	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.	The PPD will be clinically measured by using UNC 15 periodontal probe from the gingival margin to the depth of the pocket.

Secondary Outcome Measures

Name	Time	Method
Patient pain/discomfort	Postoperative Pain will be measured after the surgical procedure and 1 month, 3 months and 6 months after the intervention	Postoperative Pain will be measured by using Visual Analogue Score (VAS Score), Minimum 0 = No pain, Maximum 10 = Worst Pain possible
Patient satisfaction	Patient satisfaction will be measured after the surgical procedure and 1 month, 3 months and 6 months after the intervention	Patient satisfaction will be measured using a survey.
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	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.
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.	0 =absence of calculus; 1. =supragingival calculus extending only slightly below the free gingival margin (not more than 1 mm.); 2. = moderate amount of supra and subgingival calculus or subgingival calculus alone; 3. = an abundance of supra and subgingival calculus
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.	The CAL will be clinically measured using UNC 15 periodontal probe from the cemento-enamel junction (CEJ) to the depth of defect.
Cost effectiveness	At Baseline and 6 months post-op	Ratio of cost of treatment and time of procedure against the gained clinical benefit
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.	The BoP will be clinically measured by using UNC 15 periodontal probe from the CEJ to the gingival margin.
Treatment time	Up to 6 months	Time from picking-up the handpiece from the instrument holder to put the handpiece back.
Number of healed pockets	6 months post-op	Pocket depth of \<3.5 mm clinically measured by using UNC 15 periodontal probe from the gingival margin to the depth of the pocket.

Trial Locations

Locations (1)

Faculty of Dentistry, Cairo University; 🇪🇬 Cairo, Egypt