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

Apical Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03700788
• Other study ID #: HS-17-00292
• Status: Not yet recruiting
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Apical Periodontitis
• Periapical Periodontitis
• Periodontitis

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