Postoperative Pain After Activation of Irrigant
ConditionPain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorCleveland Dental Institute
About this trial
The purpose of this research is to analyze the levels of pain after cleaning and shaping in individuals who are receiving root canal therapy using the IVAC irrigation approach, and those who are treated with ultrasonic irrigation techniques, negative pressure irrigation technique and traditional irrigation techniques.
PICOTS Question:
Does the new Dent's iVac irrigation protocol has an effect on reduction of postoperative pain
By enlisting at least 84 suitable individuals who are undergoing the identical endodontic procedure.
pain will be measures by assessing pain levels through a standardized numerical rate scale (NRS) at certain time intervals after root canal treatment, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Conventional root canal treatment
DeviceRoot canals will be irrigated by only side perforated needle
Ultrasonic
DeviceRoot canals will finally receive activation of the irrigant by the ultrasonic part of the IVAC system
Apical negative pressure
DeviceRoot canals will finally receive activation of the irrigant by the negative pressure part of the IVAC system
Combined Ultrasonic and negative pressure
DeviceRoot canals will finally receive activation of the irrigant by the IVAC system which is a combination of ultrasonic and apical negative pressure procedures.
Treatment groups
84 Participants
are divided into 4 treatment groupsGroup A: Conventional root canal treatmentActive comparator 1 intervention
Group B: Irrigant activation with UltrasonicExperimental treatment 1 intervention
Group C: Irrigant activation with negative pressureExperimental treatment 1 intervention
Group D: Irrigant activation with both Ultrasonic and negative pressureExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Numerical Pain Scale (NRS)
Pain will be assessed during the numerical rate scale (NRS) which has a scale from 0 to 10, where 0 is no pain while 10 is most unbearable one.
Time frame
Preoperative, 6 hours, 12 hours, 24 hours, 48 hours and 72 hour post-procedure.Secondary outcomes
1
Analgesics intake
The patient will be advised to take analgesics in case of unbearable pain and record this. Number of tablets and the time will be recorded ● The satisfaction of patients regarding the pain management intervention at the follow-up
Time frame
6 hours, 12 hours, 24 hours,48 hours and 72 hour post-procedure.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov