Premedication on Post-endodontic Pain
ConditionPremedication
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age20-50
SponsorGulf Medical University
About this trial
The goal of this clinical trial is to compare the efficacy of preoperative administration of alpha-chemo-trypsin, ibuprofen, and acetaminophen in managing post-endodontic pain in patients with symptomatic irreversible pulpitis. The main question it aims to answer is:
What is the efficacy of preoperative administration of alpha-chemo-trypsin, ibuprofen, and acetaminophen in managing post-endodontic pain in patients with symptomatic irreversible pulpitis? Participants will undergo root canal treatment after premedication. Researchers will compare \[alpha-chemo-trypsin, ibuprofen, and acetaminophen\] to see the intensity of post-endodontic pain.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Eligibility for root canal treatment Patients diagnosed with symptomatic irreversible pulpitis with normal apical tissue in mandibular molars
Disqualifiers
• Patient under any medication or analgesic intake for pain management.
Patients with any systemic health issues
Patient allergies to trypsin-chymotrypsin, ibuprofen, and paracetamol
Pregnancy.
Trial design
Design model
Parallel
Treatments tested in this trial
Root canal treatment
Procedure/SurgeryHistory of presenting illness will be recorded and vitality testing will be done in addition to pre-operative radiograph. Patient will read and sign the consent form. Pre-operative pain score will be recorded using visual analogue scale. The patient will take the preoperative medication 1 hour prior to the procedure. The patient will receive 1 cartridge of LA with inferior alveolar nerve block (2% lidocaine 1:80000) and a rubber dam will be used for isolation. Access cavity will be prepared and working length will be determined. Cleaning and shaping of the root canal system will be performed followed by obturation using a standardized protocol followed by final coronal restoration. Postoperative pain score will be recorded at the 6, 12, 24, and 48 hours using visual analogue pain scale.
Treatment groups
48 Participants
are divided into 4 treatment groupsGroup A: trypsin-chymotrypsinExperimental treatment 1 intervention
Group B: IbuprofenActive comparator 1 intervention
Group C: paracetamolActive comparator 1 intervention
Group D: placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Post-endodontic pain score
Post operative pain score will be recorded using the visual analogue pain scale, where the patient will mark a point on a 10-cm line representing a continuum from 'no pain' to 'worst pain imaginable.
Time frame
6 hours2
Post-endodontic pain score
Post operative pain score will be recorded using the visual analogue pain scale, where the patient will mark a point on a 10-cm line representing a continuum from 'no pain' to 'worst pain imaginable.
Time frame
12 hours3
Post-endodontic pain score
Post operative pain score will be recorded using the visual analogue pain scale, where the patient will mark a point on a 10-cm line representing a continuum from 'no pain' to 'worst pain imaginable.
Time frame
24 hours4
Post-endodontic pain score
Post operative pain score will be recorded using the visual analogue pain scale, where the patient will mark a point on a 10-cm line representing a continuum from 'no pain' to 'worst pain imaginable.
Time frame
48 hoursSponsors and contacts
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Source ClinicalTrials.gov