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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03700788

Enrollment

Registered

2018-10-09

Start date

2023-05-30

Completion date

2025-08-31

Last updated

2023-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apical Periodontitis

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.

Interventions

DRUGChlorhexidine

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

DRUGCalcium Hydroxide

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, 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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Contacts

Primary ContactRamon Roges, D.D.S.

roges@usc.edu213-740-1576

Backup ContactC L Fath, D.D.S.

fath@usc.edu702-371-8000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026