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

Sponsor
King Abdullah University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT06144034
Collaborator
(none)
20
2
2
15.9
10
0.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Air polishing with erythritol powder
  • Device: Conventional treatment
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Split-Mouth Design Clinical TrialSplit-Mouth Design Clinical Trial
Masking:
Single (Outcomes Assessor)
Masking Description:
Outcomes Assessor was blinded to treatment intervention
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 1, 2022
Actual Primary Completion Date :
Mar 29, 2023
Actual Study Completion Date :
Jun 28, 2023

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Gingival inflammation [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 [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 [immediately after treatments of each quadrant.]

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

    4. Treatment duration [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 [immediately after treatments of each quadrant.]

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

    6. patient satisfaction [immediately after treatments of each quadrant.]

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

    Secondary Outcome Measures

    1. Biomarkers [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 [Before treatment began, immediately after, and two weeks after treatment.]

      Rustogi modified Navy plaque index

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 15 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jordan Univerity of Science and technology Irbid Jordan 21110
    2 Jordan University of Science and Technology Irbid Jordan 21110

    Sponsors and Collaborators

    • King Abdullah University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    King Abdullah University Hospital
    ClinicalTrials.gov Identifier:
    NCT06144034
    Other Study ID Numbers:
    • 635-2022
    First Posted:
    Nov 22, 2023
    Last Update Posted:
    Nov 22, 2023
    Last Verified:
    Nov 1, 2023
    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
    Keywords provided by King Abdullah University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 22, 2023