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

NCT ID: NCT03700788

Last Updated: 2023-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-30

Study Completion Date

2025-08-31

Brief Summary

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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

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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

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Apical Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

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

Study Groups

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Clorhexidine

2% Chlorhexidine

Group Type EXPERIMENTAL

Chlorhexidine

Intervention Type DRUG

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

Calcium Hydroxide

Calcium Hydroxide

Group Type ACTIVE_COMPARATOR

Calcium Hydroxide

Intervention Type DRUG

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

Interventions

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Chlorhexidine

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

Intervention Type DRUG

Calcium Hydroxide

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Ramon Roges

Associate Professor, Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rafael Roges, D.D.S.

Role: STUDY_DIRECTOR

Director, Advanced Endodontics

Locations

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Herman Ostrow USC School of Dentistry

Los Angeles, California, United States

Site Status

Countries

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United States

Central Contacts

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Ramon Roges, D.D.S.

Role: CONTACT

213-740-1576

C L Fath, D.D.S.

Role: CONTACT

702-371-8000

Other Identifiers

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HS-17-00292

Identifier Type: -

Identifier Source: org_study_id

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