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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontitis; Gingival Diseases; Periodontal Pocket; Gingival Bleeding
• Intervention / Treatment: Other: Hand and ultrasonic scalers and curettes; Device: Electro Medical Systems AIRFLOW® Prophylaxis Master Device

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.

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Asim Al Ammour, Bachelor; Phone Number: +201030593878; Email: asim.alammour@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Faculty of Dentistry, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hand and ultrasonic scalers and curettes; Hand and ultrasonic scalers and curettes will be used for supra- and subgingival instrumentation.	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.
Active Comparator: Electro Medical Systems AIRFLOW® 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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
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.
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
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
Cost effectiveness	Ratio of cost of treatment and time of procedure against the gained clinical benefit	At Baseline and 6 months post-op
Treatment time	Time from picking-up the handpiece from the instrument holder to put the handpiece back.	Up to 6 months
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Hani El-Nahas, Professor, Cairo University; Study Chair: Omnia Tawfik, Lecturer, Cairo University; Principal Investigator: Asim Al Ammour, Bachelor, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: March 20, 2024
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 8, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Erythritol; Air Abrasive
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Oral Hemorrhage; Periodontitis; Periodontal Pocket; Gingival Diseases; Gingival Hemorrhage
• Other Study ID Numbers: 211123PER3-3-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No