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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: June 30, 2025

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Clorhexidine
    • 2% Chlorhexidine
  • Active Comparator: Calcium Hydroxide
    • Calcium Hydroxide

Clinical Trial Outcome Measures

Primary Measures

  • 2% Chlorhexidine (CHX) vs CaOH2 (CH) Calcium Hydroxide Paste as an Intracanal Medicament.
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Southern California
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ramon Roges, Associate Professor, Director – University of Southern California
  • Overall Official(s)
    • Rafael Roges, D.D.S., Study Director, Director, Advanced Endodontics
  • Overall Contact(s)
    • Ramon Roges, D.D.S., 213-740-1576, roges@usc.edu

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