NCT03700788

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Apical Periodontitis

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2023-05-30
• Primary completion: 2025-06-30
• Completion: 2025-08-31
• First posted: 2018-10-09
• Last updated: 2023-03-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study