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Clinical trial

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

ID
Name
HS-17-00292
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. The overall goal is to assess whether 2% Chlorhexidine (CHX) is superior to Calcium Hydroxide in reducing interappointment pain.
Trial arms
Trial start
2023-05-30
Estimated PCD
2025-06-30
Trial end
2025-08-31
Status
Not yet recruiting
Phase
Early phase I
Treatment
Chlorhexidine
2% Chorhexidine (intracranial; remains in canal until removal at next visit)
Arms:
Clorhexidine
Calcium Hydroxide
Calcium Hydroxide (intracranial; remains in canal until removal at next visit)
Arms:
Calcium Hydroxide
Size
40
Primary endpoint
2% Chlorhexidine (CHX) vs CaOH2 (CH) Calcium Hydroxide Paste as an Intracanal Medicament.
7 days (+/- 2 days) post treatment
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Participant will be unaware as to which medication is used in the treatment procedure and will also be self-reporting outcomes.', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2023-03-08

1 organization

2 products

1 indication

Organization
University of Southern California
Product
Chlorhexidine
Indication
Apical Periodontitis
Product
Calcium Hydroxide