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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06144034
• Other study ID #: 635-2022
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: June 28, 2023

Study information

• Verified date: November 2023
• Source: King Abdullah University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 28, 2023
• Est. primary completion date: March 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Gingivitis

Intervention

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.
• Conventional treatment
Rubber cup polishing with prophy paste after biofilm disclosing, followed by ultrasonic scaling of calculus if present.

Locations

Country	Name	City	State
Jordan	Jordan Univerity of Science and technology	Irbid
Jordan	Jordan University of Science and Technology	Irbid

Sponsors (1)

Lead Sponsor	Collaborator
King Abdullah University Hospital

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	patient satisfaction	Likert Faces 5-points satisfaction scale, 0-4, 0 = Very dissatisfied. 4= Very satisficed	immediately after treatments of each quadrant.
Primary	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
Primary	Pain measure	Faces pain scale-Revised 0-10, 0 no pain, 10 maximum pain	immediately after treatments of each quadrant.
Primary	patient satisfaction	two questions, Which treatment method was less painful, Which treatment would you do again?	immediately after treatments of each quadrant.
Secondary	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.
Secondary	Residual plaque area	Rustogi modified Navy plaque index	Before treatment began, immediately after, and two weeks after treatment.