2% Chlorhexidine (CHX) vs CaOH2 (CH) Calcium Hydroxide Paste as an Intracanal Medicament

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of 2% Chlorhexidine (CHX) as Intracanal Medicament in Endodontic Emergencies and to Compare Its Use and Effectiveness With CaOH2 (CH) Calcium Hydroxide Paste

Conditions
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Apical Periodontitis

Intervention / Treatment
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* Drug: Chlorhexidine
* Drug: Calcium Hydroxide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Cracked tooth non-restorable tooth no pain medication or antibiotic taken in the past 3 days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clorhexidine<br>2% Chlorhexidine | Drug: Chlorhexidine<br>* 2% Chorhexidine (intracranial; remains in canal until removal at next visit)<br>|
| Active Comparator: Calcium Hydroxide<br>Calcium Hydroxide | Drug: Calcium Hydroxide<br>* Calcium Hydroxide (intracranial; remains in canal until removal at next visit)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2% Chlorhexidine (CHX) vs CaOH2 (CH) Calcium Hydroxide Paste as an Intracanal Medicament. | 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. | 7 days (+/- 2 days) post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Is 2% Chlorhexidine (CHX) better than Calcium Hydroxide in terms of producing fewer adverse events? | Secondarily, we will evaluate descriptively the proportion of adverse events in the two treatment groups. | 7 days (+/- 2 days) post treatment |