Dental CariesNCT00612469
The Use of Antimicrobial Agents in the Inhibition of Mutans Streptococci in Children With Dental Caries
A study testing Sodium Fluoride, vancomycin hydrochloride and chlorhexidine digluconate in people with Dental Caries, run by Universidade Federal do Ceara at 1 site in Brazil.
Trial summary
The aim of the present study was to compare salivary MS levels in four different groups of children with caries, that have been submitted to intraoral topical treatment with either 1,23% sodium fluoride, 1% chlorhexidine, 3% or 10% vancomycin, during 6 consecutive days. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Sodium Fluoride, vancomycin hydrochloride and chlorhexidine digluconate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2005to Oct 2006
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Generally healthy children
- Children with at least one carious cavitated or non-cavitated lesion
- Must be able to spit
- Must be able to collaborate during clinical intervention
Who cannot join
- Children with history of allergies or allergic diseases, e.g. asthma, urticaria, rhinitis, sinusitis, or intra-oral soft tissue lesions
- Children who underwent antibiotic treatment during the course of this clinical trial
- Children with developmental disabilities
- Children with no clinical signs dental caries
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Dentistry, Department of Clinical Dentistry, Federal University of Ceara
Fortaleza, Ceará, 60441-750
About this study
Official title: Sodium Fluoride, Chlorhexidine and Vancomycin Effect in the Inhibition of Mutans Streptococci in Children With Dental Caries: a Randomized, Double-Blind Clinical Trial
The aim of the present study was to compare salivary MS levels in four different groups of children with caries, that have been submitted to intraoral topical treatment with either 1,23% sodium fluoride, 1% chlorhexidine, 3% or 10% vancomycin, during 6 consecutive days. This clinical trial was designed to test two different hypotheses. First, that topical vancomycin would be more effective than chlorhexidine and sodium fluoride in salivary MS reduction. Secondly, a 6-day antimicrobial treatment with either one of these agents would produce a long lasting MS suppression, dispensing repeated antibacterial treatments.
Read the detailed description
The present study aimed to compare the effect of sodium fluoride, chlorhexidine and vancomycin on salivary mutans streptococci (MS) levels, on a double-blind, randomized clinical trial. Sixty-nine healthy volunteers, aged 4-8 years, with at least one active carious lesion and no previous history of allergies were selected to participate in the study. A gel formulation containing 1.23% sodium fluoride, 1% chlorhexidine, 3% or 10% vancomycin was topically administered to the dentition every 24 hours, during 6 consecutive days. Salivary MS levels were measured at baseline (D1), on the 6th (D6), 15th (D15) and 30th day (D30). For microbiological analysis, MSB agar medium was used.
- Conditions
- Dental Caries
- Being tested
- Sodium Fluoride, vancomycin hydrochloride, chlorhexidine digluconate
- Keywords
- dental caries, vancomycin, chlorhexidine, sodium fluoride, mutans streptococci
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium FluorideDrug
Topical application of 1.23% sodium fluoride to the dentition, every 24 hours, during 6 consecutive days
vancomycin hydrochlorideDrug
Also called Vanclomin, Laboratório Teuto Brasileiro S.A., Goiás, Brazil
Topical application of 3% vancomycin hydrochloride to the dentition, every 24 hours, during 6 consecutive days
vancomycin hydrochlorideDrug
Also called Vanclomin, Laboratório Teuto Brasileiro S.A., Goiás, Brazil
Topical application of 10% vancomycin hydrochloride to the primary dentition, every 24 hours, during 6 consecutive days
chlorhexidine digluconateDrug
Topical application of 1% chlorhexidine digluconate to the dentition, every 24 hours, during 6 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| NaF | Placebo comparator | Sodium fluoride application Receives: Drug: Sodium Fluoride |
| V3 | Experimental | Topical application of 3% vancomycin Receives: Drug: vancomycin hydrochloride |
| V10 | Experimental | Topical application of 10% vancomycin Receives: Drug: vancomycin hydrochloride |
| CHX | Active comparator | Topical application of 1% chlorhexidine Receives: Drug: chlorhexidine digluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary mutans streptococci levels prior to treatment, on the last day of treatment (day 6), two weeks after day 1 and 30 days after day 1.
Measured: 30-day observational period for each subject
Secondary outcomes (1)
Number of new carious lesions within the different study groups 12 months after treatment discontinuation.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startOct 2005
- Primary completionJul 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Ceara
- Sponsor type
- University, hospital or other
- Investigators
- Cristiane SR Fonteles, DDS, MS, PhD, Principal investigator, Federal University of Ceará
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00612469
- Sponsor's protocol ID
- 270/05
- Status last verified
- Dec 2007
- First submitted
- 29 Jan 2008
- Last updated
- 11 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Fluoride, Chlorhexidine and Vancomycin Effect in the Inhibition of Mutans Streptococci in Children With Dental Caries: a Randomized, Double-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT00612469
- Acronym / sponsor ID
- 270/05
- Conditions
- Dental Caries
- Keywords
- dental caries, vancomycin, chlorhexidine, sodium fluoride, mutans streptococci
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Universidade Federal do CearaUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 11 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 aim of the present study was to compare salivary MS levels in four different groups of children with caries, that have been submitted to intraoral topical treatment with either 1,23% sodium fluoride, 1% chlorhexidine, 3% or 10% vancomycin, during 6 consecutive days. This clinical trial was designed to test two different hypotheses. First, that topical vancomycin would be more effective than chlorhexidine and sodium fluoride in salivary MS reduction. Secondly, a 6-day antimicrobial treatment with either one of these agents would produce a long lasting MS suppression, dispensing repeated antibacterial treatments.
Detailed description
The present study aimed to compare the effect of sodium fluoride, chlorhexidine and vancomycin on salivary mutans streptococci (MS) levels, on a double-blind, randomized clinical trial. Sixty-nine healthy volunteers, aged 4-8 years, with at least one active carious lesion and no previous history of allergies were selected to participate in the study. A gel formulation containing 1.23% sodium fluoride, 1% chlorhexidine, 3% or 10% vancomycin was topically administered to the dentition every 24 hours, during 6 consecutive days. Salivary MS levels were measured at baseline (D1), on the 6th (D6), 15th (D15) and 30th day (D30). For microbiological analysis, MSB agar medium was used.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NaF | Placebo comparator | Drug: Sodium FluorideSodium fluoride application |
| V3 | Experimental | Drug: vancomycin hydrochlorideTopical application of 3% vancomycin |
| V10 | Experimental | Drug: vancomycin hydrochlorideTopical application of 10% vancomycin |
| CHX | Active comparator | Drug: chlorhexidine digluconateTopical application of 1% chlorhexidine |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Generally healthy children
- Children with at least one carious cavitated or non-cavitated lesion
- Must be able to spit
- Must be able to collaborate during clinical intervention
Key exclusion criteria (4 listed)
- Children with history of allergies or allergic diseases, e.g. asthma, urticaria, rhinitis, sinusitis, or intra-oral soft tissue lesions
- Children who underwent antibiotic treatment during the course of this clinical trial
- Children with developmental disabilities
- Children with no clinical signs dental caries
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 |
|---|---|---|
| Sodium FluorideTopical application of 1.23% sodium fluoride to the dentition, every 24 hours, during 6 consecutive days | Drug | NaF |
| vancomycin hydrochlorideAlso: Vanclomin, Laboratório Teuto Brasileiro S.A., Goiás, BrazilTopical application of 3% vancomycin hydrochloride to the dentition, every 24 hours, during 6 consecutive days | Drug | V3 |
| vancomycin hydrochlorideAlso: Vanclomin, Laboratório Teuto Brasileiro S.A., Goiás, BrazilTopical application of 10% vancomycin hydrochloride to the primary dentition, every 24 hours, during 6 consecutive days | Drug | V10 |
| chlorhexidine digluconateTopical application of 1% chlorhexidine digluconate to the dentition, every 24 hours, during 6 consecutive days | Drug | CHX |
Primary outcome
Salivary mutans streptococci levels prior to treatment, on the last day of treatment (day 6), two weeks after day 1 and 30 days after day 1.
Time frame: 30-day observational period for each subject
1 secondary outcome
Number of new carious lesions within the different study groups 12 months after treatment discontinuation.
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 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.
Cristiane SR Fonteles, DDS, MS, PhD principal investigator
Federal University of Ceará
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Fluoride, vancomycin hydrochloride and chlorhexidine digluconate in people with Dental Caries, 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 11 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Salivary mutans streptococci levels prior to treatment, on the last day of treatment (day 6), two weeks after day 1 and 30 days after day 1. (time frame: 30-day observational period for each subject). 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 11 Feb 2008.