2% Chlorhexidine (CHX) vs CaOH2 (CH) Calcium Hydroxide Paste as an Intracanal Medicament
Use of 2% Chlorhexidine (CHX) as Intracanal Medicament in Endodontic Emergencies and to Compare Its Use and Effectiveness With CaOH2 (CH) Calcium Hydroxide Paste
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2018
CompletedFirst Posted
Study publicly available on registry
October 9, 2018
CompletedStudy Start
First participant enrolled
May 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2025
CompletedMarch 8, 2023
March 1, 2023
2.1 years
June 5, 2018
March 6, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Is 2% Chlorhexidine (CHX) better than Calcium Hydroxide in terms of producing fewer adverse events?
7 days (+/- 2 days) post treatment
Study Arms (2)
Clorhexidine
EXPERIMENTAL2% Chlorhexidine
Calcium Hydroxide
ACTIVE COMPARATORCalcium Hydroxide
Interventions
2% Chorhexidine (intracranial; remains in canal until removal at next visit)
Calcium Hydroxide (intracranial; remains in canal until removal at next visit)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Cracked tooth
- non-restorable tooth
- no pain medication or antibiotic taken in the past 3 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Herman Ostrow USC School of Dentistry
Los Angeles, California, 90089, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rafael Roges, D.D.S.
Director, Advanced Endodontics
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Participant will be unaware as to which medication is used in the treatment procedure and will also be self-reporting outcomes.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Director
Study Record Dates
First Submitted
June 5, 2018
First Posted
October 9, 2018
Study Start
May 30, 2023
Primary Completion
June 30, 2025
Study Completion
August 31, 2025
Last Updated
March 8, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share