Apical PeriodontitisPhase 3NCT03700788
2% Chlorhexidine (CHX) vs CaOH2 (CH) Calcium Hydroxide Paste as an Intracanal Medicament
A Phase 3 study testing Chlorhexidine and Calcium Hydroxide in people with Apical Periodontitis, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- Chlorhexidine and Calcium Hydroxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2023to 31 Aug 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cracked tooth
- non-restorable tooth
- no pain medication or antibiotic taken in the past 3 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Herman Ostrow USC School of Dentistry
Los Angeles, California, 90089
About this study
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
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.
Read the 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.
- Conditions
- Apical Periodontitis
- Being tested
- Chlorhexidine, Calcium Hydroxide
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChlorhexidineDrug
2% Chorhexidine (intracranial; remains in canal until removal at next visit)
Calcium HydroxideDrug
Calcium Hydroxide (intracranial; remains in canal until removal at next visit)
| Study group | Role | What they receive |
|---|---|---|
| Clorhexidine | Experimental | 2% Chlorhexidine Receives: Drug: Chlorhexidine |
| Calcium Hydroxide | Active comparator | Calcium Hydroxide Receives: Drug: Calcium Hydroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days (+/- 2 days) post treatment
Secondary outcomes (1)
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.
Measured: 7 days (+/- 2 days) post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start30 May 2023 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramon Roges, University of Southern California
- Investigators
- Rafael Roges, D.D.S., Study director, Director, Advanced Endodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700788
- Sponsor's protocol ID
- HS-17-00292
- Status last verified
- Mar 2023
- First submitted
- 5 Jun 2018
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03700788
- Acronym / sponsor ID
- HS-17-00292
- Conditions
- Apical Periodontitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 30 May 2023 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clorhexidine | Experimental | Drug: Chlorhexidine2% Chlorhexidine |
| Calcium Hydroxide | Active comparator | Drug: Calcium HydroxideCalcium Hydroxide |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years and older
- symptomatic apical periodontitis (positive to the bite test)
- restorable tooth
- requires root canal therapy
- able to undergo informed consent process
Key exclusion criteria (3 listed)
- Cracked tooth
- non-restorable tooth
- no pain medication or antibiotic taken in the past 3 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorhexidine2% Chorhexidine (intracranial; remains in canal until removal at next visit) | Drug | Clorhexidine |
| Calcium HydroxideCalcium Hydroxide (intracranial; remains in canal until removal at next visit) | Drug | Calcium Hydroxide |
Primary outcome
2% Chlorhexidine (CHX) vs CaOH2 (CH) Calcium Hydroxide Paste as an Intracanal Medicament.
Time frame: 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.
1 secondary outcome
Is 2% Chlorhexidine (CHX) better than Calcium Hydroxide in terms of producing fewer adverse events?
Time frame: 7 days (+/- 2 days) post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafael Roges, D.D.S. study director
Director, Advanced Endodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chlorhexidine and Calcium Hydroxide in people with Apical Periodontitis, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ramon Roges, D.D.S. (213-740-1576, roges@usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2% Chlorhexidine (CHX) vs CaOH2 (CH) Calcium Hydroxide Paste as an Intracanal Medicament. (time frame: 7 days (+/- 2 days) post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.