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Trial record 12 of 32 for:    FLUORIDE ION AND NITRATE ION

The Caries-arresting Effect of Incorporating fTCP to NaF Varnish Applied Following AgNO3 in Preschool Children

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ClinicalTrials.gov Identifier: NCT03423797
Recruitment Status : Active, not recruiting
First Posted : February 6, 2018
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Chun-Hung Chu, The University of Hong Kong

Brief 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.

Condition or disease Intervention/treatment Phase
Early Childhood Caries Drug: 25% AgNO3 solution followed by 5% NaF Drug: 25% AgNO3 solution followed by 5% NaF with fTCP Phase 3

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 453 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Biannual Application of Silver Nitrate Solution Followed by Sodium Fluoride Varnish With or Without Functionalized Tricalcium Phosphate in Arresting Caries in Preschool Children
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Toddler Health

Arm Intervention/treatment
Active Comparator: NaF without fTCP
25% AgNO3 solution followed by 5% NaF.
Drug: 25% AgNO3 solution followed by 5% NaF
Dosage: 25% AgNO3 solution 7.9mg(Ag+)/0.05ml (max dose), 5% NaF: 11.6mg (F-)/0.5ml (max dose).
Other Name: 5% NaF without fTCP

Experimental: NaF with fTCP
25% AgNO3 solution followed by 5% NaF with fTCP.
Drug: 25% AgNO3 solution followed by 5% NaF with fTCP
Dosage: 25% AgNO3 solution 7.9mg(Ag+)/0.05ml (max dose), 5% NaF with fTCP: 11.6mg (F-)/0.5ml (max dose).
Other Name: 5% NaF with fTCP




Primary Outcome Measures :
  1. The hardness of cavity on tooth by probing [ Time Frame: The follow-up oral examinations will be conducted every 6 months for 30 months totally ]
    The effectiveness of adjunctive application of 25% AgNO3 solution and 5% NaF varnish with or without fTCP is expected to be equivalent in arresting dentine caries of primary teeth.



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Ages Eligible for Study:   3 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • have at least one tooth with cavitated dentine carious lesion

Exclusion Criteria:

  • Children have severe forms of dental hypoplasia, under dental treatment or wearing orthodontic devices, have major systemic illness, and are on long-term medication.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423797


Locations
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China
The University of Hong Kong
Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Chun Hung Chu, Ph.D The University of Hong Kong

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Chun-Hung Chu, Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03423797     History of Changes
Other Study ID Numbers: UW 17-176
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Chun-Hung Chu, The University of Hong Kong:
silver nitrate
sodium fluoride
dental caries
equivalence trial
Additional relevant MeSH terms:
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Silver Nitrate
Pharmaceutical Solutions
Fluorides
Sodium Fluoride
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents