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

Primary Purpose

Apical Periodontitis

Status
Not yet recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Chlorhexidine
Calcium Hydroxide
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apical Periodontitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Herman Ostrow USC School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Clorhexidine

Calcium Hydroxide

Arm Description

2% Chlorhexidine

Calcium Hydroxide

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 5, 2018
Last Updated
March 6, 2023
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT03700788
Brief Title
2% Chlorhexidine (CHX) vs CaOH2 (CH) Calcium Hydroxide Paste as an Intracanal Medicament
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 30, 2023 (Anticipated)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apical Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Participant will be unaware as to which medication is used in the treatment procedure and will also be self-reporting outcomes.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clorhexidine
Arm Type
Experimental
Arm Description
2% Chlorhexidine
Arm Title
Calcium Hydroxide
Arm Type
Active Comparator
Arm Description
Calcium Hydroxide
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine
Intervention Description
2% Chorhexidine (intracranial; remains in canal until removal at next visit)
Intervention Type
Drug
Intervention Name(s)
Calcium Hydroxide
Intervention Description
Calcium Hydroxide (intracranial; remains in canal until removal at next visit)
Primary Outcome Measure Information:
Title
2% Chlorhexidine (CHX) vs CaOH2 (CH) Calcium Hydroxide Paste as an Intracanal Medicament.
Description
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.
Time Frame
7 days (+/- 2 days) post treatment
Secondary Outcome Measure Information:
Title
Is 2% Chlorhexidine (CHX) better than Calcium Hydroxide in terms of producing fewer adverse events?
Description
Secondarily, we will evaluate descriptively the proportion of adverse events in the two treatment groups.
Time Frame
7 days (+/- 2 days) post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ramon Roges, D.D.S.
Phone
213-740-1576
Email
roges@usc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
C L Fath, D.D.S.
Phone
702-371-8000
Email
fath@usc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafael Roges, D.D.S.
Organizational Affiliation
Director, Advanced Endodontics
Official's Role
Study Director
Facility Information:
Facility Name
Herman Ostrow USC School of Dentistry
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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