Clinical trial NCT06144034: Air Polishing Effect on Biological, Clinical and Patient-reported Experience Among Epileptic and Non-epileptic Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Gingivitis
Keywords: Air polishing
Airflow
Erythritol
Oral health of special healthcare needs children
Lead sponsor: King Abdullah University Hospital
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split-Mouth Design Clinical Trial
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gingival inflammation
timeFrame: Before treatment began, and two weeks after treatment.
measure: Mean Marginal Plaque
timeFrame: Before treatment began, immediately after, and two weeks after treatment.
measure: patient satisfaction
timeFrame: immediately after treatments of each quadrant.
measure: Treatment duration
timeFrame: from the time procedure begins until removing all dental biofilm and calculus
measure: Pain measure
timeFrame: immediately after treatments of each quadrant.
measure: patient satisfaction
timeFrame: immediately after treatments of each quadrant.
Secondary outcomes:
measure: Biomarkers
timeFrame: Before treatment began, and two weeks after treatment.
measure: Residual plaque area
timeFrame: Before treatment began, immediately after, and two weeks after treatment.
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Jordan Univerity of Science and technology
city: Irbid
country: Jordan
facility: Jordan University of Science and Technology
Study officials:
References: