2% Chlorhexidine (CHX) vs CaOH2 (CH) Calcium Hydroxide Paste as an Intracanal Medicament
- Conditions
- Apical Periodontitis
- Interventions
- Registration Number
- NCT03700788
- Lead Sponsor
- University of Southern California
- Brief Summary
This is a Pilot Phase III single-blind randomized controlled clinical trial in patients, aged 18 years and older, presenting with symptoms of apical periodontitis. The overall goal is to assess whether 2% Chlorhexidine (CHX) is superior to Calcium Hydroxide in reducing interappointment pain.
- Detailed Description
This is a Pilot Phase III single-blind randomized controlled clinical trial in patients, aged 18 years and older, presenting with symptoms of apical periodontitis. Patients will be treated with one of two current clinically-used medications, 2% chlorohexidine (intervention) vs. calcium hydroxide (standard-of-care). One week following treatment (+/- 2 days), patients will return for reevaltuion of apical periodontitis symptoms, via patient's pain perception after a bite test.
The primary objective of the proposed study is to determine if there is a difference in 7-day (+/- 2) post-procedure apical periodontitis following randomization to either 2% chlorohexidine vs. calcium hydroxide paste among patients presenting with symptoms of apical periodontitis. Additionally, the investigators will assess the number of adverse events that occur in each treatment group to determine if there appears to be a difference across groups, descriptively.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 18 years and older
- symptomatic apical periodontitis (positive to the bite test)
- restorable tooth
- requires root canal therapy
- able to undergo informed consent process
- must be English or Spanish speaker
- Cracked tooth
- non-restorable tooth
- no pain medication or antibiotic taken in the past 3 days
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Calcium Hydroxide Calcium Hydroxide Calcium Hydroxide Clorhexidine Chlorhexidine 2% Chlorhexidine
- Primary Outcome Measures
Name Time Method 2% Chlorhexidine (CHX) vs CaOH2 (CH) Calcium Hydroxide Paste as an Intracanal Medicament. 7 days (+/- 2 days) post treatment The endpoint for the proposed study will be self-reported pain post-bite test, as recorded on the visual analog scale (VAS) 7 (+/- 2) days post treatment. We will be using the Visual Analog Scale (range 1-100) and plan to analyze this as a continuous variable to maintain maximum statistical power.
- Secondary Outcome Measures
Name Time Method Is 2% Chlorhexidine (CHX) better than Calcium Hydroxide in terms of producing fewer adverse events? 7 days (+/- 2 days) post treatment Secondarily, we will evaluate descriptively the proportion of adverse events in the two treatment groups.
Trial Locations
- Locations (1)
Herman Ostrow USC School of Dentistry
🇺🇸Los Angeles, California, United States