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

Sponsor

University of Southern California (Other)

Overall Status

Unknown status

CT.gov ID

NCT03700788

Collaborator

(none)

Enrollment

Location

Arms

29.4

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Apical Periodontitis	Drug: Chlorhexidine Drug: Calcium Hydroxide	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Participant will be unaware as to which medication is used in the treatment procedure and will also be self-reporting outcomes.

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

May 30, 2019

Anticipated Primary Completion Date :

Oct 31, 2021

Anticipated Study Completion Date :

Nov 9, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Clorhexidine 2% Chlorhexidine	Drug: Chlorhexidine 2% Chorhexidine (intracranial; remains in canal until removal at next visit)
Active Comparator: Calcium Hydroxide Calcium Hydroxide	Drug: Calcium Hydroxide Calcium Hydroxide (intracranial; remains in canal until removal at next visit)

Arm

Intervention/Treatment

Experimental: Clorhexidine

2% Chlorhexidine

Drug: Chlorhexidine

2% Chorhexidine (intracranial; remains in canal until removal at next visit)

Active Comparator: Calcium Hydroxide

Calcium Hydroxide

Drug: Calcium Hydroxide

Calcium Hydroxide (intracranial; remains in canal until removal at next visit)

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Herman Ostrow USC School of Dentistry	Los Angeles	California	United States	90089

Sponsors and Collaborators

University of Southern California

Investigators

Study Director: Rafael Roges, D.D.S., Director, Advanced Endodontics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ramon Roges, Associate Professor, Director, University of Southern California

ClinicalTrials.gov Identifier:

NCT03700788

Other Study ID Numbers:

HS-17-00292

First Posted:

Oct 9, 2018

Last Update Posted:

Apr 8, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Periodontitis

Periapical Periodontitis

Chlorhexidine

Calcium

Study Results

No Results Posted as of Apr 8, 2019