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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.
Select...
I speak English or Spanish.
Select...
I have pain in my tooth when I bite down.
Select...
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
905 Previous Clinical Trials
1,596,238 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are seniors eligible to participate in the current trials for this treatment option?

"This trial has an age range of 18 to 80 years old, meaning the lower and upper limit are respectively set at the legal age of consent and octogenarian status."

Answered by AI

What adverse effects have been noted with Clorhexidine use?

"Our risk assessment team gave Clorhexidine a rating of 3 due to the evidence provided by Phase 3 clinical trials demonstrating its efficacy and safety."

Answered by AI

Who meets the criteria to participate in this experimental research?

"To meet the qualifications for this trial, patients need to be diagnosed with apical periodontitis and between 18-80 years of age. Approximately 40 individuals will receive admission into the study."

Answered by AI

What are the most common ailments that Clorhexidine is employed to address?

"Clorhexidine is a common and effective remedy for antisepsis, as well as disinfection of the throat area, minor cuts and scrapes, and pressure ulcers."

Answered by AI

How many participants are currently involved in this research project?

"This experiment is currently not seeking participants, as per its last update on March 6th 2023. If you are in search of alternate studies, there are 88 trials recruiting individuals with apical periodontitis and 23 clinical tests that need volunteers for Clorhexidine research."

Answered by AI

Has Clorhexidine been tested before in a clinical setting?

"As of now, 23 experiments related to the efficacy of Clorhexidine are being conducted. Six trials have reached Phase 3 and 96 clinical sites across the country are taking part in its research. The major concentration is in Los Angeles, California."

Answered by AI

Are there any vacancies left in this research program?

"According to the details listed on clinicaltrials.gov, this research is no longer seeking patients; it was initially posted on May 30th 2023 and last updated in March 6th 2023. Nonetheless, there are 111 other trials currently recruiting participants at the moment."

Answered by AI
~22 spots leftby Jun 2025