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

NCT06144034 | Completed

• 1 other identifier: 635-2022
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Epilepsy; Gingivitis

Keywords

Air polishing; Airflow; Erythritol; Oral health of special healthcare needs children

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Biomarkers

  Before treatment began, and two weeks after treatment.

• Residual plaque area

  Before treatment began, immediately after, and two weeks after treatment.

Study Arms (2)

Epilepsy patients

EXPERIMENTAL

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; Device: Conventional treatment

Non-epileptic pateints

EXPERIMENTAL

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; Device: Conventional treatment

Interventions

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.

Also known as: Airflow

Epilepsy patients; Non-epileptic pateints

Conventional treatment DEVICE

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

Also known as: Rubber cup polishing

Epilepsy patients; Non-epileptic pateints

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• King Abdullah University Hospital: lead

Study Sites (2)

Jordan Univerity of Science and technology

Irbid, 21110, Jordan

Location

Jordan University of Science and Technology

Irbid, 21110, Jordan

Location

MeSH Terms

Conditions

Epilepsy; Gingivitis

Interventions

Pulmonary Ventilation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor was blinded to treatment intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Split-Mouth Design Clinical Trial

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 22, 2023
• Study Start: March 1, 2022
• Primary Completion: March 29, 2023
• Study Completion: June 28, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

JO (2)