Evaluation of Efficacy of Calcium Hydroxide and Simvastatin as Intracanal Medicament Using ATP Bioluminescence Meter: A Randomized Clinical Trial.
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Evaluation of ATP levels(microbial load level) after root canal instrumentation and after removal of simvastatin and calcium hydroxide
Study Overview
Brief Summary
Primary purpose of the study: To evaluate the microbial levels(ATP levels) after root canal instrumentation and after removal of simvastatin and calcium hydroxide intracanal medicament.
Hypothesis: To evaluate the microbial levels after root canal instrumentation and after removal of simvastatin and calcium hydroxide intracanal medicament.
Null hypothesis:
There is no significant difference in ATP levels before and after calcium hydroxide intracanal medicament.There is no significant difference in ATP levels before and after simvastatin intracanal medicament.There is no significant difference in ATP levels betweencalcium hydroxide and simvastatin as intracanal medicament.
Alternative hypothesis:
There is significant difference in ATP levels before and after calcium hydroxide intracanal medicament.There is significant difference in ATP levels before and after simvastatin intracanal medicament.There is significant difference in ATP levels between calcium hydroxide and simvastatin as intracanal medicament.
Study design: 100 patients diagnosed with pulp necrosis with symptomatic apical periodontitis will be recruited from outpatient. After randomization, patients will be treated with either simvastatin and calcium hydroxide intracanal medicament. After removal of simvastatin and calcium hydroxide intracanal medicament, 100ul liquid collected in syringe will be used for testing ATP levels using Bioluminescence meter.
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients diagnosed with pulp necrosis and symptomatic apical periodontitis Patients diagnosed with pulp necrosis and chronic apical abscess Patients diagnosed with symptomatic irreversible pulpitis and symptomatic apical periodontitis Patients diagnosed with pulp necrosis and acute apical abscess.
Exclusion Criteria
- •patients diagnosed with absence of pain patients who are not willing to participate in the study patients diagnosed with root fractures.
Outcomes
Primary Outcomes
Evaluation of ATP levels(microbial load level) after root canal instrumentation and after removal of simvastatin and calcium hydroxide
Time Frame: Evaluation of ATP levels (indicative of microbial load) after root canal instrumentation at 45 minutes and following the removal of simvastatin and calcium hydroxide after one week.
Secondary Outcomes
- post operative pain evaluation after placement of simvastatin and calcium hydroxide and after their removal(post operative pain evaluation after placement of simvastatin and calcium hydroxide at 8hrs,24hrs,48hrs,72hrs and after their removal at 7 days)
Investigators
Sagala Tejaswini
Sibar institute of dental sciences