Air Polishing Effect on Biological, Clinical and Patient-reported Experience Among Epileptic and Non-epileptic Children

Effect of Air Polishing for Biofilm Removal on Clinical, Biological, and Patient-Reported Experience Among Epileptic and Non-Epileptic Children: A Split-Mouth Randomised Clinical Trial

In epileptic and non Epileptic children, the full dentition of each patient was split into four quadrants, starting from the upper right quadrant (1) and moving clockwise until the lower right quadrant (4). Bundled into two groups: quadrant (1+3) vs. (2+4). After randomization, each of these pairs of quadrants had the same treatment modality; test quadrants received treatment with airflow to remove soft biofilm, and ultrasonic scaler for areas with calculus deposits, and control quadrants were treated with conventional rubber cup polishing to remove soft biofilm and ultrasonic scaler for calculus deposits.

Study Overview

• Status: Completed
• Conditions: Epilepsy; Gingivitis
• Intervention / Treatment: Device: Air polishing with erythritol powder; Device: Conventional treatment

Detailed Description

The treatment of each quadrant was administered sequentially, beginning with the upper right quadrant. Treatment duration was measured in seconds from the start of treatment in each quadrant until the removal of all disclosed biofilm and calculus. This process was repeated for each quadrant individually. And intra-oral photographs were taken before, immediately after treatment, and at follow-up time.

Conventional treatment was conducted after biofilm disclosure by a rubber cup and prophylaxis paste spearmint (Kemdent Works, Purton. Swindon, Wiltshire. SN5 4HT, UK). The power setting was between 70% and 100%. The rubber cup was used until all biofilm was removed, then, if present, calculus was removed by Electro Medical Systems (EMS) ultrasonic scaler with a power setting between 3-6 on the Airflow control panel.

For Airflow, treatment was conducted after biofilm disclosure. The powder chamber of the air polishing device was filled with low-abrasive erythritol powder, according to the manufacturer's instructions. The tip of the handpiece was positioned at an angle of 70° to the surface of the tooth to be polished at 3 mm from the tooth surface. Once activated, a non-stop movement from mesial to distal and distal to mesial in a smiley face shape starting from the gingival sulcus and moving upwards coronally to the incisal to cover the entire clinical crown was performed, with a power setting ranging from 3-6 on the control panel of the airflow device. EMS ultrasonic scaler was used to remove calculus if present with a power ranging from 3-6.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jordan
  • Irbid, Jordan, 21110
    • Jordan University of Science and Technology
  • Irbid, Jordan, 21110
    • Jordan Univerity of Science and technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• children aged 5 to 15 years with epilepsy
• on anti-epileptic drugs (AED) for at least 3 months
• periodontal pockets depths not exceeding 3mm
• full-mouth plaque scores over 50%, and having 5 teeth per quadrant.
• The non-epileptic group included healthy non-epileptic children meeting similar criteria for age, periodontal health, and plaque scores

Exclusion Criteria:

• coexisting neurological illnesses other than epilepsy, medical conditions impacting oral health, periodontitis, asthma, swallowing difficulties, intellectual disabilities, and non-ambulatory status

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: Epilepsy patients; 1 and 3 quadrants got the same treatment and 2 and 4 got the same treatment. Air polishing with erythritol powder was used to remove biofilm and EMS ultrasonic scaler to remove calculus if present. also rubber cup and prophylaxis paste spearmint (Kemdent Works, Purton. Swindon, Wiltshire. SN5 4HT, UK). and EMS ultrasonic scaler to remove calculus if present.	Device: Air polishing with erythritol powder; Air polishing with erythritol powder utilized for biofilm disclosing and, followed by an ultrasonic scaler to remove calculus if present.; Other Names: Airflow; Device: Conventional treatment; Rubber cup polishing with prophy paste after biofilm disclosing, followed by ultrasonic scaling of calculus if present.; Other Names: Rubber cup polishing
Experimental: Non-epileptic pateints; 1 and 3 quadrants got the same treatment and 2 and 4 got the same treatment. Air polishing with erythritol powder was used to remove biofilm and EMS ultrasonic scaler to remove calculus if present. also rubber cup and prophylaxis paste spearmint (Kemdent Works, Purton. Swindon, Wiltshire. SN5 4HT, UK). and EMS ultrasonic scaler to remove calculus if present.	Device: Air polishing with erythritol powder; Air polishing with erythritol powder utilized for biofilm disclosing and, followed by an ultrasonic scaler to remove calculus if present.; Other Names: Airflow; Device: Conventional treatment; Rubber cup polishing with prophy paste after biofilm disclosing, followed by ultrasonic scaling of calculus if present.; Other Names: Rubber cup polishing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival inflammation	using Loe and Silness gingival index. Before biofilm disclosing, evaluated by assigning scores from 0-3 for gingival inflammation at four sites (mesial, distal, buccal, and lingual/palatal) per tooth, 0- normal gingiva and 3 - severely inflamed	Before treatment began, and two weeks after treatment.
Mean Marginal Plaque	O'Leary Plaque Index on 6 sites per tooth, 0= absence of plaque or 1= presence of plaque	Before treatment began, immediately after, and two weeks after treatment.
patient satisfaction	Likert Faces 5-points satisfaction scale, 0-4, 0 = Very dissatisfied. 4= Very satisficed	immediately after treatments of each quadrant.
Treatment duration	for each quadrant, time was measured from beginning of treatment till biofilm and calculus are fully removed per seconds	from the time procedure begins until removing all dental biofilm and calculus
Pain measure	Faces pain scale-Revised 0-10, 0 no pain, 10 maximum pain	immediately after treatments of each quadrant.
patient satisfaction	two questions, Which treatment method was less painful, Which treatment would you do again?	immediately after treatments of each quadrant.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarkers	Gingival crevicular fluid samples IL-1B and MMP-8 two samples per patient, one for each treatment method	Before treatment began, and two weeks after treatment.
Residual plaque area	Rustogi modified Navy plaque index	Before treatment began, immediately after, and two weeks after treatment.

Collaborators and Investigators

• Sponsor: King Abdullah University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): March 29, 2023
• Study Completion (Actual): June 28, 2023

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: November 20, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Erythritol; Air polishing; Airflow; Oral health of special healthcare needs children
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis; Vasodilator Agents; Erythritol
• Other Study ID Numbers: 635-2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No