Gulf Medical University
Ajman, 4184, United Arab Emirates
Location status: Recruiting
Recruiting
NCT Number: NCT06671743
Premedication on Post-endodontic Pain
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
20 year–50 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Eligibility for root canal treatment Patients diagnosed with symptomatic irreversible pulpitis with normal apical tissue in mandibular molars
Exclusion criteria
- • 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.
- Non-restorable teeth.
- Immature roots.
- Calcifications.
- Resorptions.
Treatment and study plan
Root canal treatment
ProcedureHistory 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.
Primary outcomes
-
Post-endodontic pain score
Time frame: 6 hours
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.
-
Post-endodontic pain score
Time frame: 12 hours
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.
-
Post-endodontic pain score
Time frame: 24 hours
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.
-
Post-endodontic pain score
Time frame: 48 hours
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Gulf Medical University
Other
Registry information
Official study title
Effect of Premedication on Post-endodontic Pain in Patients With Symptomatic Irreversible Pulpitis, a Triple-blinded Randomized Control Trial
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Nov 4, 2024
- Registry last updated
- Nov 4, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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