CTRI/2020/10/028484Not yet recruitingPhase 4
Impact of passively placed sodium hypochlorite in a calcium hydroxide dressing on root canal disinfection and periapical tissue response: a randomized controlled trial
Manipal College of Dental Sciences1 site in 1 country110 target enrollmentStarted: October 25, 2020Last updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Microbial samples from root canal
Study Overview
Brief Summary
Two types of intracanal medicament will be used (NaOCl + calcium hydroxide and calcium hydroxide alone) and the microbial samples and periapical inflammatory markers will be assessed from the teeth with pulpal necrosis.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •pulpal diagnosis of necrosis and an apical diagnosis of symptomatic/asymptomatic apical periodontitis.
Exclusion Criteria
- •(i) a chronic condition requiring the intake of anti-inflammatory/antibiotic drugs, (ii) tooth which cannot be isolated by rubber dam properly, (iii) a non-restorable tooth, or (iv) root canals in which patency for periapical fluid sampling cannot not be achieved.
Outcomes
Primary Outcomes
Microbial samples from root canal
Time Frame: one week
Secondary Outcomes
- periapical markers(4 weeks)
Investigators
Study Sites (1)
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