Clinical trial
Effect of Different Concentrations of Sodium Hypochlorite on Post Operative Pain Following Single Visit Root Canal Treatment
Name
Sodium Hypochlorite NaOCl
Description
This is a randomized, prospective, double-blind, clinical trial to assess the effect of 3% and 6% sodium hypochlorite (NaOCl) as irrigant on postendodontic pain and rescue medication intake following single visit root canal treatment
Trial arms
Trial start
2023-04-30
Estimated PCD
2023-10-30
Trial end
2023-10-31
Status
Recruiting
Phase
Early phase I
Treatment
Irrigation Solution
Different concentrations of NaOCl are being used as the endodontic irrigant.
Arms:
3% NaOCl concentration group, 6% NaOCl concentration group
Other names:
Root Canal Disinfection
Size
66
Primary endpoint
Post-operative pain after root canal treatment
1 week
Eligibility criteria
Inclusion Criteria:
* Healthy individuals between 18 to 55 years
* First and second mandibular molar diagnosed with irreversible pulpitis due to caries
* Patients with moderate pain will be selected, VAS score (4 - 6).
* Normal periapical radiographic appearance
* Mild tender to percussion
* No allergies to articaine
Exclusion Criteria:
* Patients who have taken analgesic or anti-inflammatory drugs within 6 hours before treatment visit
* Pregnant or lactating patients
* Teeth with severe periodontal disease
* Teeth that cannot be isolated with rubber dam
* Teeth undergone over-instrumentation or overfilling beyond apex
* Teeth with calcifications/ resorptive defects
* History of allergy to any materials used in the study
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 66, 'type': 'ESTIMATED'}}
Updated at
2023-05-03
1 organization
1 product
1 indication
Organization
Armed Forces Institute of DentistryProduct
Irrigation SolutionIndication
Postoperative Pain