EpilepsyNCT06144034
Air Polishing Effect on Biological, Clinical and Patient-reported Experience Among Epileptic and Non-epileptic Children
A study testing Air polishing with erythritol powder and Conventional treatment in people with Epilepsy and Gingivitis, run by King Abdullah University Hospital at 2 sites in Jordan.
Trial 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). Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Gingivitis
- What is being tested?
- Air polishing with erythritol powder and Conventional treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesJordan
- Study dates
- 1 Mar 2022to 28 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- coexisting neurological illnesses other than epilepsy, medical conditions impacting oral health, periodontitis, asthma, swallowing difficulties, intellectual disabilities, and non-ambulatory status
Trial locations and contacts
2 sites in 1 country.
Jordan2 sites
Jordan Univerity of Science and technology
Irbid, 21110
Jordan University of Science and Technology
Irbid, 21110
About this study
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
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.
Read the 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.
- Conditions
- Epilepsy, Gingivitis
- Being tested
- Air polishing with erythritol powder, Conventional treatment
- Keywords
- Air polishing, Airflow, Erythritol, Oral health of special healthcare needs children
- Medical subject headings
- Epilepsy, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air polishing with erythritol powderDevice
Also called Airflow
Air polishing with erythritol powder utilized for biofilm disclosing and, followed by an ultrasonic scaler to remove calculus if present.
Conventional treatmentDevice
Also called Rubber cup polishing
Rubber cup polishing with prophy paste after biofilm disclosing, followed by ultrasonic scaling of calculus if present.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Air polishing with erythritol powder; Device: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: immediately after treatments of each quadrant.
patient satisfaction
two questions, Which treatment method was less painful, Which treatment would you do again?
Measured: immediately after treatments of each quadrant.
Secondary outcomes (2)
Biomarkers
Gingival crevicular fluid samples IL-1B and MMP-8 two samples per patient, one for each treatment method
Measured: Before treatment began, and two weeks after treatment.
Residual plaque area
Rustogi modified Navy plaque index
Measured: Before treatment began, immediately after, and two weeks after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start1 Mar 2022
- Primary completion29 Mar 2023
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split-Mouth Design Clinical Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144034
- Sponsor's protocol ID
- 635-2022
- Status last verified
- Nov 2023
- First submitted
- 13 Nov 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06144034
- Acronym / sponsor ID
- 635-2022
- Conditions
- Epilepsy, Gingivitis
- Keywords
- Air polishing, Airflow, Erythritol, Oral health of special healthcare needs children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 29 Mar 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Split-Mouth Design Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Epilepsy patients | Experimental | Device: Air polishing with erythritol powder, Device: Conventional treatment1 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. |
| Non-epileptic pateints | Experimental | Device: Air polishing with erythritol powder, Device: Conventional treatment1 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. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- coexisting neurological illnesses other than epilepsy, medical conditions impacting oral health, periodontitis, asthma, swallowing difficulties, intellectual disabilities, and non-ambulatory status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Air polishing with erythritol powderAlso: AirflowAir polishing with erythritol powder utilized for biofilm disclosing and, followed by an ultrasonic scaler to remove calculus if present. | Device | Epilepsy patients, Non-epileptic pateints |
| Conventional treatmentAlso: Rubber cup polishingRubber cup polishing with prophy paste after biofilm disclosing, followed by ultrasonic scaling of calculus if present. | Device | Epilepsy patients, Non-epileptic pateints |
Primary outcome
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
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
patient satisfaction
Time frame: immediately after treatments of each quadrant.
Likert Faces 5-points satisfaction scale, 0-4, 0 = Very dissatisfied. 4= Very satisficed
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
Pain measure
Time frame: immediately after treatments of each quadrant.
Faces pain scale-Revised 0-10, 0 no pain, 10 maximum pain
patient satisfaction
Time frame: immediately after treatments of each quadrant.
two questions, Which treatment method was less painful, Which treatment would you do again?
2 secondary outcomes
Biomarkers
Time frame: Before treatment began, and two weeks after treatment.
Residual plaque area
Time frame: Before treatment began, immediately after, and two weeks after treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air polishing with erythritol powder and Conventional treatment in people with Epilepsy and Gingivitis, run by King Abdullah University Hospital at 2 sites in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival inflammation (time frame: Before treatment began, and two weeks after treatment.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.