Caries,Dental Clinical Trial
— BTCFOfficial title:
Birth to Three - Cavity Free: Effectiveness of a Psychoeducational Intervention for ECC Prevention
NCT number | NCT05756413 |
Other study ID # | 202002391 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2023 |
Est. completion date | March 31, 2027 |
Early childhood caries (ECC) is a potentially painful and debilitating disease, which represents a significant public health problem among young children. There are profound disparities in ECC experiences such that children from minority and low-income families suffer a disproportionate share of the disease burden. The likelihood of parents of high-ECC risk young children seeking prevention in dental facilities is low; therefore, there is a need to increase preventive dental opportunities where these children already seek health care services. In particular, there is an urgent need to develop and evaluate ECC behavioral interventions for use in public health settings attended by high-risk children. Many authors recommend early implementation of oral health education as one means of preventing ECC. However, major issues discussed in the oral health promotion literature involve a lack of effectiveness among programs based on education alone, as well as a lack of high quality preventive interventions using evidence-based psychological and behavioral strategies. Our research team has been the first to introduce to the ECC prevention arena the self-determination theory (SDT) of motivation, internalization, and healthy functioning, proven effective in promoting positive behavioral changes in several other fields, including oral health care. The investigators have demonstrated that SDT has great promise as a motivational approach by providing evidence, based on results from our R21 (R21-DE016483) study, of the effectiveness of SDT in changing several desirable oral health behaviors for ECC prevention. Building upon the rigor of our previous experience and formative research work in the past several years, the investigators propose a Stage II NIH Model research project that will compare the efficacy of autonomy-supportive videotaped oral health messages framed by SDT to more traditional neutral videotaped messages. The investigators intend to recruit 634 pregnant mothers enrolled in Iowa Women, Infants and Children (WIC) Supplemental Nutrition Programs and follow them until their future child is 36 months old. The primary outcome of interest will be children's caries status. Secondary outcomes will be changes in children's oral health behaviors conducive to better oral hygiene and dietary habits, as well as lower levels of dental plaque and mutans streptococci.
Status | Recruiting |
Enrollment | 634 |
Est. completion date | March 31, 2027 |
Est. primary completion date | March 31, 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - WIC-participating pregnant women who are 18 to 45 years old - Between 12 and 36 weeks of the gestational period - Able to speak, understand and read English or Spanish - No intention to move away in the next 4 years Exclusion Criteria: - Mothers who deliver their child prior to their first study intervention visit |
Country | Name | City | State |
---|---|---|---|
United States | Anamosa WIC Clinic | Anamosa | Iowa |
United States | Belle Plaine WIC Clinic | Belle Plaine | Iowa |
United States | LCPH WIC Clinic | Cedar Rapids | Iowa |
United States | Urban WIC Clinic | Cedar Rapids | Iowa |
United States | Clinton WIC Clinic | Clinton | Iowa |
United States | Columbus Junction WIC Clinic | Columbus Junction | Iowa |
United States | CHC Edgerton Clinic | Davenport | Iowa |
United States | Davenport WIC Clinic | Davenport | Iowa |
United States | Dewitt WIC Clinic | De Witt | Iowa |
United States | Johnson County WIC | Iowa City | Iowa |
United States | Maquoketa WIC Clinic | Maquoketa | Iowa |
United States | Marion WIC Clinic | Marion | Iowa |
United States | Monticello WIC Clinic | Monticello | Iowa |
United States | Muscatine WIC Clinic | Muscatine | Iowa |
United States | Tipton WIC Clinic | Tipton | Iowa |
United States | Vinton WIC Clinic | Vinton | Iowa |
Lead Sponsor | Collaborator |
---|---|
University of Iowa |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Caries Status | The primary outcome of interest is children's caries status, as measured by the number of decayed, missing or filled surfaces using the d1d2-3 mfs scoring method. Both d2-3 and d1 levels, derived from the d1d2-3mfs caries criteria, will be considered, reflecting numbers of affected (cavitated, missing due to caries or filled) surfaces with and without inclusion of non-cavitated (d1 "white spot") lesions. | Visits 2 when children are 12 months of age | |
Primary | Caries Status | The primary outcome of interest is children's caries status, as measured by the number of decayed, missing or filled surfaces using the d1d2-3 mfs scoring method. Both d2-3 and d1 levels, derived from the d1d2-3mfs caries criteria, will be considered, reflecting numbers of affected (cavitated, missing due to caries or filled) surfaces with and without inclusion of non-cavitated (d1 "white spot") lesions. | Visits 3 when children are 24 months of age | |
Primary | Caries Status | The primary outcome of interest is children's caries status, as measured by the number of decayed, missing or filled surfaces using the d1d2-3 mfs scoring method. Both d2-3 and d1 levels, derived from the d1d2-3mfs caries criteria, will be considered, reflecting numbers of affected (cavitated, missing due to caries or filled) surfaces with and without inclusion of non-cavitated (d1 "white spot") lesions. | Visits 4 when children are 36 months of age | |
Secondary | Maternal knowledge questionnaire | Secondary outcomes will be changes in maternal knowledge on oral health care | Visit 1-4, including activities at 1- and 9-month between site visits | |
Secondary | Children's oral health behavior questionnaire | Secondary outcomes will be changes in maternal oral health behaviors towards their children | Visit 1-4, including activities at 1- and 9-month between site visits | |
Secondary | Levels of dental plaque | Secondary outcomes will be changes in levels of children's dental plaque. Visible plaque will be assessed first and recorded as present or absent for the maxillary and mandibular incisors and molars. The number of maxillary and mandibular incisors and molars with plaque will also be recorded. | Visits 2, 3 and 4 when children are 12-, 24- and 36-months of age, respectively | |
Secondary | Levels of mutans streptococci (MS) | Secondary outcomes will be changes in levels of children's mutans streptococci (MS) | Visits 2, 3 and 4 when children are 12-, 24- and 36-months of age, respectively |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05792215 -
KAP of Dental Practitioners Regarding CRA
|
||
Not yet recruiting |
NCT05792800 -
Dental Practitioners KAP Regarding Caries Preventive Measures in Cairo and Riyadah
|
||
Withdrawn |
NCT04104789 -
Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - General
|
Phase 2 | |
Active, not recruiting |
NCT06211582 -
Clinical Performances of 3-different Tooth-colored Restorative Materials in Class-II Cavities
|
N/A | |
Active, not recruiting |
NCT04342858 -
Prospective Randomized Controlled Trial for Prevention of Demineralization During Fixed Orthodontic Treatment
|
Phase 2 | |
Recruiting |
NCT05362461 -
Diagnostic Ability of Near Infrared Transillumination Detecting Interproximal Caries as Compared to Conventional Bitewing Radiographs
|
||
Not yet recruiting |
NCT04422860 -
Remineralization Efficacy of Gum Arabic Varnish.
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT06063239 -
Probiotics in Special Needs Patients at High Risk for Tooth Decay: a Randomized Controlled Trial.
|
N/A | |
Completed |
NCT04286256 -
Using Motivational Interviewing To Reduce Parental Risk-Related Behaviors For Early Childhood Caries
|
N/A | |
Completed |
NCT06182267 -
Maximal Use Study to Determine the Pharmacokinetics of L-arginine After Exaggerated Oral Use of COL101
|
Phase 1 | |
Not yet recruiting |
NCT03671200 -
Correlation Between Caries Experience in Primary Molars and First Permanent Molars
|
||
Not yet recruiting |
NCT06365281 -
Caries Prevalence, Experience and Risk Related Factors Among Early Middle-aged Patients Attending Cairo University
|
||
Completed |
NCT06242184 -
Post-operative Sensitivity in Resin Composites
|
N/A | |
Completed |
NCT04003493 -
LifE Style, Nutrition and Oral Health in Care Givers (LENTO)
|
N/A | |
Enrolling by invitation |
NCT04251858 -
Evaluation of Oral Condition and the Effect of Dental Treatment on Physical Parameters of Athletes
|
N/A | |
Terminated |
NCT01796106 -
Clinical Trial Proximal Caries Infiltration and Detection
|
N/A | |
Not yet recruiting |
NCT05943782 -
Evaluation of CAD/CAM Onlays Fabricated by Subtractive Versus Additive Digital Manufacturing Techniques.
|
N/A | |
Recruiting |
NCT06114030 -
Clinical and Radiographical Evaluation of CAD-CAM Crowns With and Without Deep Margin Elevation
|
N/A | |
Completed |
NCT05231330 -
Clinical Evaluation of Silver Nanoparticles in Comparison to Silver Diamine Fluoride in Management of Deep Carious Lesions
|
N/A | |
Not yet recruiting |
NCT04303767 -
The Effect of Casein Phosphopeptide Amorphous Calcium Phosphate on Affected Dentine
|
Phase 2 |