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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03700788
Other study ID # HS-17-00292
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date May 30, 2023
Est. completion date August 31, 2025

Study information

Verified date March 2023
Source University of Southern California
Contact Ramon Roges, D.D.S.
Phone 213-740-1576
Email roges@usc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date August 31, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Intervention

Drug:
Chlorhexidine
2% Chorhexidine (intracranial; remains in canal until removal at next visit)
Calcium Hydroxide
Calcium Hydroxide (intracranial; remains in canal until removal at next visit)

Locations

Country Name City State
United States Herman Ostrow USC School of Dentistry Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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