Dental Pulp NecrosisPhase 2NCT00624572
Efficacy of Chlorexidine as Intracanal Medicament in Primary Teeth
A Phase 2 study testing chlorexidine in people with Dental Pulp Necrosis, run by Universidade Federal do Ceara at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the action of the chlorexidine as intracanal medicament in the reduction of the levels of bacteria inside root canals of primary molar teeth with pulpal necrosis. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Dental Pulp Necrosis
- What is being tested?
- chlorexidine
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2007to Feb 2009
- Phase
- Phase 2
- 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy children of both gender;
- Without history of reactions or alergical diseases;
- With situated age between 04 and 08 years of age
- With normal standard of growth and development
- Patients with necessity of radical endodontic treatment (pulpectomy) in, at least, two primary molar teeth in different hemi-arches.
Who cannot join
- Patients with history of alergical diseases
- Patients with allergy to any type of medicine and/or foods
- Patients with comprometimento of its general state of health
- Healthy patients with risk to develop bacterial endocardite or patients that their general state of health can be aggravated had the transitory bacteremies, as for example children with congenital cardiac illnesses
- Patients who are making use of sistemis antibiotics, or that they have made use of sistemic antibiotic in the period of 3 (three) months before the beginning of the endodontic treatment
- With periapical x-ray evidencing less than 2/3 of remaining root of the primary tooth to be treated
- Patients whose tooth with endodontic necessity to meet in advanced state of root pathological reabsortion
- Patients whose legal responsible or parents to refuse to sign the term of free and clarified assent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of 1% Chlorexidine Gel as Intracanal Medicament in Primary Molar Teeth - a Clinical and Microbiological Study
The purpose of this study is to evaluate the action of the chlorexidine as intracanal medicament in the reduction of the levels of bacteria inside root canals of primary molar teeth with pulpal necrosis.
- Conditions
- Dental Pulp Necrosis
- Being tested
- chlorexidine
- Keywords
- primary teeth, chlorexidine, root canal therapy, Pulpectomy
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chlorexidineDrug
Chlorexidine gel 1% during 7 days inside root canals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2008 (estimated)
- Study startOct 2007
- Primary completionNov 2008 (estimated)
- Study completionFeb 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Pulp NecrosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Ceara
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624572
- Sponsor's protocol ID
- CHX0784
- Status last verified
- Feb 2008
- First submitted
- 15 Feb 2008
- Last updated
- 27 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of 1% Chlorexidine Gel as Intracanal Medicament in Primary Molar Teeth - a Clinical and Microbiological Study
- ClinicalTrials.gov ID
- NCT00624572
- Acronym / sponsor ID
- CHX0784
- Conditions
- Dental Pulp Necrosis
- Keywords
- primary teeth, chlorexidine, root canal therapy, Pulpectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidade Federal do CearaUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Nov 2008 (estimated)
- Study completion
- Feb 2009 (estimated)
- First posted
- 27 Feb 2008 (estimated)
- 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.
The purpose of this study is to evaluate the action of the chlorexidine as intracanal medicament in the reduction of the levels of bacteria inside root canals of primary molar teeth with pulpal necrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy children of both gender;
- Without history of reactions or alergical diseases;
- With situated age between 04 and 08 years of age
- With normal standard of growth and development
- Patients with necessity of radical endodontic treatment (pulpectomy) in, at least, two primary molar teeth in different hemi-arches.
Key exclusion criteria (8 listed)
- Patients with history of alergical diseases
- Patients with allergy to any type of medicine and/or foods
- Patients with comprometimento of its general state of health
- Healthy patients with risk to develop bacterial endocardite or patients that their general state of health can be aggravated had the transitory bacteremies, as for example children with congenital cardiac illnesses
- Patients who are making use of sistemis antibiotics, or that they have made use of sistemic antibiotic in the period of 3 (three) months before the beginning of the endodontic treatment
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 |
|---|---|---|
| chlorexidineChlorexidine gel 1% during 7 days inside root canals | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing chlorexidine in people with Dental Pulp Necrosis, run by Universidade Federal do Ceara at 1 site in Brazil.
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 5 inclusion and 8 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 27 Feb 2008. 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 Brazil. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 27 Feb 2008.