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

NCT ID: NCT06144034

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-06-28

Brief Summary

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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

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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.

Conditions

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Epilepsy Gingivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Split-Mouth Design Clinical Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Outcomes Assessor was blinded to treatment intervention

Study Groups

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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.

Group Type EXPERIMENTAL

Air polishing with erythritol powder

Intervention Type DEVICE

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

Conventional treatment

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

Air polishing with erythritol powder

Intervention Type DEVICE

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

Conventional treatment

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Conventional treatment

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

Intervention Type DEVICE

Other Intervention Names

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Airflow Rubber cup polishing

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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King Abdullah University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Jordan Univerity of Science and technology

Irbid, , Jordan

Site Status

Jordan University of Science and Technology

Irbid, , Jordan

Site Status

Countries

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Jordan

Other Identifiers

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635-2022

Identifier Type: -

Identifier Source: org_study_id