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Alkali

Chlorhexidine vs Calcium Hydroxide for Tooth Pain

Phase 3
Waitlist Available
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
must be English or Spanish speaker
Restorable tooth
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days (+/- 2 days) post treatment
Awards & highlights

Study Summary

This trial will compare two treatments for tooth pain to find which is better at reducing pain between dentist visits.

Who is the study for?
This trial is for adults over 18 with symptomatic apical periodontitis who need root canal therapy and can consent to treatment. Participants must speak English or Spanish, have a restorable tooth, and not have taken pain medication or antibiotics in the past 3 days.Check my eligibility
What is being tested?
The study compares two treatments for gum disease-related pain: Chlorhexidine (CHX) versus Calcium Hydroxide (CH). It aims to determine if CHX is better at reducing pain between dental appointments than CH.See study design
What are the potential side effects?
Possible side effects may include teeth sensitivity, allergic reactions, or irritation around the treated area. Both medications are generally well-tolerated when used as intracanal medicaments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I speak English or Spanish.
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I have a tooth that can be fixed.
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I feel pain in my tooth when I bite down.
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I have a tooth that can be fixed.
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I need a root canal treatment.
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I speak English or Spanish.
Select...
I have pain in my tooth when I bite down.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days (+/- 2 days) post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days (+/- 2 days) post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
2% Chlorhexidine (CHX) vs CaOH2 (CH) Calcium Hydroxide Paste as an Intracanal Medicament.
Secondary outcome measures
Is 2% Chlorhexidine (CHX) better than Calcium Hydroxide in terms of producing fewer adverse events?

Side effects data

From 2020 Phase 2 trial • 44 Patients • NCT02252588
8%
Other oral side effects
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chlorhexidine
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ClorhexidineExperimental Treatment1 Intervention
2% Chlorhexidine
Group II: Calcium HydroxideActive Control1 Intervention
Calcium Hydroxide
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chlorhexidine
FDA approved

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
916 Previous Clinical Trials
1,604,784 Total Patients Enrolled
Rafael Roges, D.D.S.Study DirectorDirector, Advanced Endodontics

Media Library

Calcium Hydroxide (Alkali) Clinical Trial Eligibility Overview. Trial Name: NCT03700788 — Phase 3
Apical Periodontitis Research Study Groups: Clorhexidine, Calcium Hydroxide
Apical Periodontitis Clinical Trial 2023: Calcium Hydroxide Highlights & Side Effects. Trial Name: NCT03700788 — Phase 3
Calcium Hydroxide (Alkali) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03700788 — Phase 3
~19 spots leftby Jun 2025
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