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NCT Number: NCT06144034

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

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Gingival Diseases Gingivitis Infections Mouth Diseases Nervous System Diseases Periodontal Diseases Stomatognathic Diseases

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordan Univerity of Science and technology, Irbid, Jordan

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Air polishing with erythritol powder

Device

Air polishing with erythritol powder utilized for biofilm disclosing and, followed by an ultrasonic scaler to remove calculus if present.

Other names: Airflow

Conventional treatment

Device

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

Other names: Rubber cup polishing

Primary outcomes

  1. Gingival inflammation

    Time frame: Before treatment began, and two weeks after treatment.

    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

  2. Mean Marginal Plaque

    Time frame: Before treatment began, immediately after, and two weeks after treatment.

    O'Leary Plaque Index on 6 sites per tooth, 0= absence of plaque or 1= presence of plaque

  3. patient satisfaction

    Time frame: immediately after treatments of each quadrant.

    Likert Faces 5-points satisfaction scale, 0-4, 0 = Very dissatisfied. 4= Very satisficed

  4. Treatment duration

    Time frame: from the time procedure begins until removing all dental biofilm and calculus

    for each quadrant, time was measured from beginning of treatment till biofilm and calculus are fully removed per seconds

  5. Pain measure

    Time frame: immediately after treatments of each quadrant.

    Faces pain scale-Revised 0-10, 0 no pain, 10 maximum pain

  6. patient satisfaction

    Time frame: immediately after treatments of each quadrant.

    two questions, Which treatment method was less painful, Which treatment would you do again?

Secondary outcomes

  1. Biomarkers

    Time frame: Before treatment began, and two weeks after treatment.

    Gingival crevicular fluid samples IL-1B and MMP-8 two samples per patient, one for each treatment method

  2. Residual plaque area

    Time frame: Before treatment began, immediately after, and two weeks after treatment.

    Rustogi modified Navy plaque index

Sponsors and collaborators

Lead sponsor

King Abdullah University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 22, 2023
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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