Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06144034
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2023-11-13
Brief Title:
Air Polishing Effect on Biological Clinical and Patient-reported Experience Among Epileptic and Non-epileptic Children
Sponsor:
King Abdullah University Hospital
Organization:
King Abdullah University Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 13 vs 24 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 manufacturers 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
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 manufacturers 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None