Clinical Trials Logo

Clinical Trial Summary

The objective of this study is to compare the effectiveness of 25% AgNO3 solution plus 5% NaF varnish and 25% AgNO3 solution plus 5% NaF varnish with fTCP when applied semi-annually over 30 months in arresting dentine caries of primary teeth among preschool children. Half of Participants will receive topical application of 25% AgNO3 solution and 5% NaF varnish, while the other half will receive topical application of 25% AgNO3 solution and 5% NaF varnish with fTCP.


Clinical Trial Description

Aim:The objective of this study is to compare the effectiveness of commercially available of 25% AgNO3 solution plus 5% NaF varnish and 25% AgNO3 solution plus 5% NaF varnish with fTCP when applied semi-annually over 30 months in arresting dentine caries of primary teeth among preschool children. Methods: The extension of the Consolidated Standards of Reporting Trials 2010 Statement will be followed for this 30-month, randomised, double-blinded, equivalence clinical trial. Approximately 2,000 kindergarten children will be screened and at least 376 children with caries will be recruited. This sample size is sufficient for an appropriate statistical analysis. The children will be randomly allocated into 2 groups to treat their caries over a 30-month period: Group A - biannual application of a 25% AgNO3 solution followed by a 5% NaF varnish, and Group B - biannual application of a 25% AgNO3 solution followed by a 5% NaF varnish with functionalized tricalcium phosphate (fTCP).Clinical examinations will be conducted at 6-month intervals to assess whether the caries are arrested (primary outcome). Confounding factors such as oral hygiene habits will be collected through a parental questionnaire. Possible results and implications: As the first of its kind, this study would help to determine whether AgNO3 followed by 5% NaF varnish with and without fTCP are equivalent in arresting dentine caries of primary teeth in preschool children when applied semi-annually. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03423797
Study type Interventional
Source The University of Hong Kong
Contact
Status Completed
Phase Phase 3
Start date September 1, 2017
Completion date August 30, 2020

See also
  Status Clinical Trial Phase
Completed NCT02019160 - Effectiveness of Dental Caries Arrest Treatment in Primary Teeth Using AgNO3 Followed by NaF Varnish Phase 3
Recruiting NCT05272254 - Povidone Iodine Efficacy Study Phase 2
Not yet recruiting NCT05370989 - Technology-Based Parent School Program N/A
Recruiting NCT04665219 - HBM for Empowering Parental Toothbrushing and Sugar Intake Control N/A
Not yet recruiting NCT04003129 - Knowledge, Practice and Attitude of Paediatricians Regarding Early Childhood Caries
Completed NCT03693443 - Knowledge and Behavior Toward Early Childhood Caries
Completed NCT04655430 - Effect of Application Time of 38% Silver Diamine Fluoride Solution on Arresting Dental Caries in Preschool Childre Phase 2/Phase 3
Completed NCT05515510 - Acceptance and Efficacy of a Digital Application Among Parents to Control Early Childhood Caries N/A
Completed NCT04054635 - A Clinical Trial of Silver Diamine Fluoride to Arrest Early Childhood Caries in Young Children N/A
Recruiting NCT05260216 - Clinical Analysis of a Risk-graded and Comprehensive Intervention for Early-childhood-caries N/A
Completed NCT03625310 - Effectiveness Fluoride Varnishes in Children With Early Childhood Caries N/A
Completed NCT05748054 - Early Childhood Caries in Jordanian Children N/A
Not yet recruiting NCT04737057 - Clinical Efficiency and Child's Behavior of Hall Versus SDF Techniques in the Management of Carious Primary Molar: N/A
Completed NCT03162822 - Caregiver-Child Interaction and Health Behaviors N/A
Completed NCT04456335 - Investigation of Supragingival Plaque Microbiome in Early Childhood Caries
Recruiting NCT05352841 - Leptin, Adiponectin, FRAP and Tac in Patients With Early Childhood Caries
Terminated NCT04556175 - Great Beginnings for Healthy Native Smiles: An Early Childhood Caries Prevention Project N/A
Completed NCT05761041 - Silver Diamine Fluoride Versus Sodium Fluoride Varnish With Parental Behavior Modification in Arresting Early Childhood Caries Phase 3
Completed NCT03360266 - Evaluation of Remineralizing Efficacy of Combination Varnishes on White Spot Lesions in ECC Children N/A
Not yet recruiting NCT05716867 - Salivary Cystatin S Levels in a Group of Egyptian Children