Dental CariesPhase 3NCT00066950
Prevention Management Model for Early Childhood Caries (MAYA Project)
A Phase 3 study testing Chlorhexidine gluconate and Fluoride Varnish in people with Dental Caries, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to determine whether dental disease patterns and transmissable bacteria that are known to cause a severe form of dental decay in young children can be reduced or eliminated by treating mothers and their young infants early on with Chlorhexidine and fluoride varnish applications… Read more about this study
- Who is it for?
- Ages 18 to 33 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Chlorhexidine gluconate and Fluoride Varnish
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 361 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Aug 2005
- 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 33 years
- All sexes
- Healthy volunteers accepted
- Adult
"Inclusion Criteria"
- Some evidence of geographic stability in South San Diego Bay Area
- Planning on remaining in area approximately 3 years after birth of child
- Must be able to provide consent in English or Spanish
- Must be registered patients at San Ysidro Health Center in the prenatal program
- Must be experiencing a normal pregnancy
"Exclusion Criteria"
- Diabetes, anemia, placenta previa, seizure disorders, GDM, evidence of chromosomal disorders, Polyhydramnios, Thrombophlebitis, or RH-negative status
- Vaginal bleeding, premature uterine contractions, viral or bacterial infections, diabetes, pregnant with twins or multiple births expected
- Previous pregnancy complications where hospitalization was required
Trial locations and contacts
1 site in 1 country.
United States1 site
San Ysidro Health Center
San Ysidro, California, 92173
About this study
Official title: Prevention Management Model for Early Childhood Caries
The purpose of this study is to determine whether dental disease patterns and transmissable bacteria that are known to cause a severe form of dental decay in young children can be reduced or eliminated by treating mothers and their young infants early on with Chlorhexidine and fluoride varnish applications, respectively as part of a comprehensive Prevention Management Model.
Read the detailed description
The primary aim is to evaluate two programs, a minimal intervention program and a moderate intensity program, for preventing Early Childhood Caries. A four-year randomized clinical trial will be conducted specifically to: 1) Assess demographic and behavioral factors as predictors of ECC and the relationship between three-year post-intervention behavioral changes from baseline measures with disease outcomes; 2) Compare the efficacy for the prevention of ECC in two groups - the minimal intervention group (Group 1) receiving counseling alone, with the moderate intensity group (Group 2) receiving a) counseling and a therapeutic four-month regimen of Chlorhexidine rinse for new mothers and b) fluoride varnish applications for their infants and toddlers starting at twelve months of age and continuing to age 30 months; 3) Assess baseline salivary microbiological markers as predictors of ECC in the infants of women in both groups and the relationship between three-year post-intervention salivary markers and changes from baseline measures with disease outcomes; 4) Assess the impact of a caries-preventive model in lowering the salivary mutans streptococci level in post-partum women, and subsequently, in inhibiting the growth of these bacteria in their young children, delaying the infectious process.
The long term objectives are to build upon our understanding of caries risk factors, to assess the effectiveness of a prevention management model, to improve access to preventive oral health services and information for low-income pregnant women and their young children, and to reduce oral health disparities in a border population (U.S. - Mexico Border near San Diego Bay Area) at high risk for dental disease.
- Conditions
- Dental Caries
- Being tested
- Chlorhexidine gluconate, Fluoride Varnish
- Keywords
- Early childhood caries
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine gluconateDrug
Also called Peridex® OMNII Oral Pharmaceuticals
0.5oz chlorhexidine gluconate 0.12% solution mouth rinse twice daily for 14 days then no rinse for 14 days, repeated for 3 months
Fluoride VarnishDevice
Also called CavityShield® OMNII Oral Pharmaceuticals
0.25ml FV every 6 months from age 12 to 30 months
| Study group | Role | What they receive |
|---|---|---|
| Counseling Only | No intervention | Oral Health Counseling Only |
| CHX+Counseling (caregiver) + FV (child) | Experimental | Oral Health Counseling plus Chlorhexidine for caregiver plus fluoride varnish every 6 months from 12mo to 30mo of age for child Receives: Drug: Chlorhexidine gluconate; Device: Fluoride Varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries Incidence and Caries Index
Caries Incidence (number of participants who developed caries during the study) and the number of decayed or filled tooth surfaces (dfs) index.
Measured: 4 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2003 (estimated)
- Study startMar 2003
- Primary completionJul 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- San Ysidro Health Center, University of California, San Diego, San Diego State University
- Responsible party
- Sponsor
- Investigators
- Francisco J Ramos-Gomez, DDS,MS, MPH, Principal investigator, University of California, Los AngelesStuart A Gansky, DrPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00066950
- Sponsor's protocol ID
- NIDCR-14251
- Status last verified
- Mar 2022
- First submitted
- 7 Aug 2003
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ramos-Gomez F, Chung LH, Gonzalez Beristain R, Santo W, Jue B, Weintraub J, Gansky S. Recruiting and retaining pregnant women from a community health center at the US-Mexico border for the Mothers and Youth Access clinical trial. Clin Trials. 2008;5(4):336-46. doi: 10.1177/1740774508093980.
PubMed 18697848Ramos-Gomez FJ, Gansky SA, Featherstone JD, Jue B, Gonzalez-Beristain R, Santo W, Martinez E, Weintraub JA. Mother and youth access (MAYA) maternal chlorhexidine, counselling and paediatric fluoride varnish randomized clinical trial to prevent early childhood caries. Int J Paediatr Dent. 2012 May;22(3):169-79. doi: 10.1111/j.1365-263X.2011.01188.x. Epub 2011 Oct 17.
PubMed 21999806Chaffee BW, Gansky SA, Weintraub JA, Featherstone JD, Ramos-Gomez FJ. Maternal oral bacterial levels predict early childhood caries development. J Dent Res. 2014 Mar;93(3):238-44. doi: 10.1177/0022034513517713. Epub 2013 Dec 19.
PubMed 24356441
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention Management Model for Early Childhood Caries
- ClinicalTrials.gov ID
- NCT00066950
- Acronym / sponsor ID
- NIDCR-14251
- Conditions
- Dental Caries
- Keywords
- Early childhood caries
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- San Ysidro Health Center, University of California, San Diego, San Diego State University
- Study start
- Mar 2003
- Primary completion
- Jul 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 8 Aug 2003 (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 determine whether dental disease patterns and transmissable bacteria that are known to cause a severe form of dental decay in young children can be reduced or eliminated by treating mothers and their young infants early on with Chlorhexidine and fluoride varnish applications, respectively as part of a comprehensive Prevention Management Model.
Detailed description
The primary aim is to evaluate two programs, a minimal intervention program and a moderate intensity program, for preventing Early Childhood Caries. A four-year randomized clinical trial will be conducted specifically to: 1) Assess demographic and behavioral factors as predictors of ECC and the relationship between three-year post-intervention behavioral changes from baseline measures with disease outcomes; 2) Compare the efficacy for the prevention of ECC in two groups - the minimal intervention group (Group 1) receiving counseling alone, with the moderate intensity group (Group 2) receiving a) counseling and a therapeutic four-month regimen of Chlorhexidine rinse for new mothers and b) fluoride varnish applications for their infants and toddlers starting at twelve months of age and continuing to age 30 months; 3) Assess baseline salivary microbiological markers as predictors of ECC in the infants of women in both groups and the relationship between three-year post-intervention salivary markers and changes from baseline measures with disease outcomes; 4) Assess the impact of a caries-preventive model in lowering the salivary mutans streptococci level in post-partum women, and subsequently, in inhibiting the growth of these bacteria in their young children, delaying the infectious process.
The long term objectives are to build upon our understanding of caries risk factors, to assess the effectiveness of a prevention management model, to improve access to preventive oral health services and information for low-income pregnant women and their young children, and to reduce oral health disparities in a border population (U.S. - Mexico Border near San Diego Bay Area) at high risk for dental disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Counseling Only | No intervention | –Oral Health Counseling Only |
| CHX+Counseling (caregiver) + FV (child) | Experimental | Drug: Chlorhexidine gluconate, Device: Fluoride VarnishOral Health Counseling plus Chlorhexidine for caregiver plus fluoride varnish every 6 months from 12mo to 30mo of age for child |
Who may qualify
- Ages
- 18 to 33 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Chlorhexidine gluconateAlso: Peridex® OMNII Oral Pharmaceuticals0.5oz chlorhexidine gluconate 0.12% solution mouth rinse twice daily for 14 days then no rinse for 14 days, repeated for 3 months | Drug | CHX+Counseling (caregiver) + FV (child) |
| Fluoride VarnishAlso: CavityShield® OMNII Oral Pharmaceuticals0.25ml FV every 6 months from age 12 to 30 months | Device | CHX+Counseling (caregiver) + FV (child) |
Primary outcome
Caries Incidence and Caries Index
Time frame: 4 year
Caries Incidence (number of participants who developed caries during the study) and the number of decayed or filled tooth surfaces (dfs) index.
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 21 Mar 2022.
- Results publication: PubMed 18697848Ramos-Gomez F, Chung LH, Gonzalez Beristain R, Santo W, Jue B, Weintraub J, Gansky S. Recruiting and retaining pregnant women from a community health center at the US-Mexico border for the Mothers and Youth Access clinical trial. Clin Trials. 2008;5(4):336-46. doi: 10.1177/1740774508093980.
- Results publication: PubMed 21999806Ramos-Gomez FJ, Gansky SA, Featherstone JD, Jue B, Gonzalez-Beristain R, Santo W, Martinez E, Weintraub JA. Mother and youth access (MAYA) maternal chlorhexidine, counselling and paediatric fluoride varnish randomized clinical trial to prevent early childhood caries. Int J Paediatr Dent. 2012 May;22(3):169-79. doi: 10.1111/j.1365-263X.2011.01188.x. Epub 2011 Oct 17.
- Results publication: PubMed 24356441Chaffee BW, Gansky SA, Weintraub JA, Featherstone JD, Ramos-Gomez FJ. Maternal oral bacterial levels predict early childhood caries development. J Dent Res. 2014 Mar;93(3):238-44. doi: 10.1177/0022034513517713. Epub 2013 Dec 19.
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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.
Francisco J Ramos-Gomez, DDS,MS, MPH principal investigator
University of California, Los Angeles
Stuart A Gansky, DrPH principal investigator
University of California, San Francisco
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 gluconate and Fluoride Varnish in people with Dental Caries, run by University of California, San Francisco 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?
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 21 Mar 2022. 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?
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?
Caries Incidence and Caries Index (time frame: 4 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00066950, which also lists 3 linked publications.
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 21 Mar 2022.