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Clinical trial

The Effect of Trypsin-Chymotrypsin On Postoperative Pain After Single Visit Endodontic Treatment A Randomized Controlled Trial

ID
Name
FDASU-Rec IM012110
Description
Achieving effective pain control after endodontic treatment is still a disruptive event to all the clinicians. There is a knowledge gap regarding the effect of protease on postoperative pain following root canal treatment, therefore, the efficacy of Trypsin-Chymotrypsin on post endodontic pain was evaluated clinically in a randomized triple-blind trial.
Trial arms
Trial start
2021-06-01
Estimated PCD
2021-12-31
Trial end
2021-12-31
Status
Completed
Phase
Early phase I
Treatment
post operative analgesics
post-operative pain killer
Arms:
Ibuprofen (Brufen), Ibuprofen (Brufen) + Trypsin 5 mg Chymotrypsin 5 mg (Ambezim G), Placebo pills (Sugar pills), Trypsin 5 mg Chymotrypsin 5 mg (Ambezim G)
Other names:
pain control drug
Size
60
Primary endpoint
Effect of Trypsin-Chymotrypsin on Post-operative Pain After Single Endodontic Treatment in Teeth With Symptomatic Irreversible Pulpitis
from 6 hours following drug intake after obturation to 72 hours (start with 6 hours first interval then at 12 hours intervals)
Eligibility criteria
Inclusion criteria: * Egyptian healthy symptomatic both gender patients * aged (18- 40) years old * with no physical disability, facial paresthesia or psychological problems * had mandibular first molars with symptomatic irreversible pulpitis and with normal appearance radiographically. Exclusion criteria: * The vulnerable group * participants who un abled to read and fill the questionnaire, * those who took preoperative analgesics 24 h prior to treatment * those with known sensitivity to the drugs used in this study
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2024-03-01

1 organization

1 product

1 indication

Organization
Ain Shams University
Product
Post Operative Analgesics
Indication
Drug Effect