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

April 4, 2019 updated by: Ramon Roges, University of Southern California

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90089
        • Herman Ostrow USC School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Clorhexidine
2% Chlorhexidine
Drug: Chlorhexidine
2% Chorhexidine (intracranial; remains in canal until removal at next visit)
ACTIVE_COMPARATOR: Calcium Hydroxide
Drug: Calcium Hydroxide
Calcium Hydroxide (intracranial; remains in canal until removal at next visit)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2% Chlorhexidine (CHX) vs CaOH2 (CH) Calcium Hydroxide Paste as an Intracanal Medicament.
Time Frame: 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.
7 days (+/- 2 days) post treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 30, 2019

Primary Completion (ANTICIPATED)

October 31, 2021

Study Completion (ANTICIPATED)

November 9, 2021

Study Registration Dates

First Submitted

June 5, 2018

First Submitted That Met QC Criteria

October 5, 2018

First Posted (ACTUAL)

October 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2019

Last Update Submitted That Met QC Criteria

April 4, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-17-00292

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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