An interventional study of SureSmile® VPro™ and ortho technology, sports advantage, thermal forming soft EVA 3mm in Pain, sponsored by University of Baghdad. Status unknown at 1 site in Iraq. Open to participants aged 15 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-15.
Sponsored by University of Baghdad · Not applicable, Interventional, and Prevention
The goal of this clinical trial is to evaluate the effectiveness of four different methods (including the control group) in reducing pain during debonding of fixed orthodontic appliances in participants requiring the removal of their fixed orthodontic appliance.
The main question it aims to answer is which method (biting on a cotton roll, biting on a soft thermoplastic elastomeric sheet, and the use of low-level vibration in reducing pain during the debonding procedure) is most effective in reducing the patients' pain during debonding of conventional orthodontic fixed appliances.
Participants will be asked to give their pain score on a scale of 0 to 100 VAS (visual analogue scale) for every region of the dentition.
the researcher then will compare different scores of different methods to find the most effective method in reducing pain.
After signing the consent form, the patient will be tested using General Anxiety Disorder 7 (GAD-7) to reduce the effect of general anxiety on pain scores. GAD consists of 7 statements designed to measure anxiety. This will aid in identifying individuals who have severe anxiety disorder and exclude them from the study to ensure more accurate results.
Four debonding methods will be used in this study; Routine mechanical debonding with debonding plier with an open mouth, which will be used as control, and three other interventions to manage pain including biting on a cotton roll, biting on an elastomeric wafer, and using vibration. All of the procedures will be done with the archwire in situ and with minimal torsional force on the bracket.
For the control group, the debonding will be done with an open-mouth technique without any support applied to the teeth. The cotton roll method will be done by asking the patient to bite on the cotton roll firmly but not excessively during the debonding procedure.
As for the elastomeric wafer group the patient will bite on the wafer firmly during the debonding procedure, in a similar fashion the patient will bite on the mouthpiece of the VPro vibration device.
Pain will be estimated by using 100mm VAS and recording the results for each sextant, accompanied by the GAD-7 results and the patient's age and gender.
2,450 studies on the registry are indexed under Pain; 945 are open to participants now.
This study's planned enrollment of 128 is above the median of 70 across 2,101 interventional studies indexed under Pain.
Browse Pain studies →University of Baghdad is the lead sponsor of 166 studies on the registry; 65 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
debonding of the bracket is done while the mouth of the patient is open and without any support to the teeth during the debonding procedure
debonding of the bracket is done while the patient is biting on the preshaped soft elastomeric wafer (cut into a horseshoe shape) during the debonding procedure
Other: ortho technology, sports advantage, thermal forming soft EVA 3mm
debonding of the bracket is done while the patient is biting on a cotton roll during the debonding procedure
Other: cotton roll
debonding of the bracket is done while the patient is biting on the mouthpiece of the vibrational device (SureSmile® VPro™) delivering vibrations to the dentition during the debonding procedure
Device: SureSmile® VPro™
the pain is recorded when the patient is biting on the mouthpiece of the device during the debonding procedure
the pain is recorded when the patient is biting on the EVA sheet during the debonding procedure
the pain is recorded when the patient is biting on the cotton roll during the debonding procedure
pain during debonding of conventional fixed orthodontic appliance
pain will be estimated using 0-100 VAS (visual analogue scale) of each segment of the dentition during the debonding procedure
Time frame: Intraprocedural
the dentition segment with the highest pain scores
will be measured statistically
Time frame: Intraprocedural
Plan to share: Yes — Data obtained through this study may be provided to qualified researchers with an academic interest in pain and debonding of conventional fixed orthodontic appliances. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
Access criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA)
Started Mar 2023 (actual). Primary completion is estimated for Oct 2023, 6 months after the start.
Of 1,253 non-industry interventional studies with no phase under Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 29. This study's planned 6 months is below that.
Counting every sponsor, half of 1,276 studies reached it within 11 months; a quarter within 5 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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