Ignite Creation Date:
2024-05-06 @ 3:59 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02424097
Status:
COMPLETED
Last Update Posted:
2020-04-22
First Post:
2015-04-15
Brief Title:
MI Varnish and MI Paste Plus in a Caries Prevention and Remineralization Study
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
MI Varnish and MI Paste Plus in a Caries Prevention and Remineralization Study
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GC-WS
Brief Summary:
The objective of this clinical study is to evaluate the efficacy of multiple applications of MI Varnish in combination with MI Paste Plus in caries protection and remineralization in comparison to the use of a control Crest 1100ppm Fluoride tooth paste Fluoride rinse recommendation in orthodontic patients in a randomized single blind prospective controlled clinical trial over 12 months
The effect will be measured by white spot lesion regression and prevention as lesion count Lesions will be scored using the Enamel Decalcification Index EDI area evaluation scheme primary outcome International Caries Detection and Assessment System ICDAS the caries lesion activity criteria Nyvad criteria Bente Nyvad Scandinavian Researcher and Quantitative Light Fluorescence QLF Inspektor Pro NetherlandsSOPROLIFE SOPROLIFE fluorescence camera system Acteon France evaluation in maxillary and mandibular anterior teeth with orthodontic brackets in treatment and control groups
The effect will be measured by white spot lesion regression and prevention as lesion count Lesions will be scored using the Enamel Decalcification Index EDI area evaluation scheme primary outcome International Caries Detection and Assessment System ICDAS the caries lesion activity criteria Nyvad criteria Bente Nyvad Scandinavian Researcher and Quantitative Light Fluorescence QLF Inspektor Pro NetherlandsSOPROLIFE SOPROLIFE fluorescence camera system Acteon France evaluation in maxillary and mandibular anterior teeth with orthodontic brackets in treatment and control groups
Detailed Description:
The study is designed as randomized single blind prospective clinical trial over 12 months The subjects for this study will be recruited from the University of California at San Francisco UCSF School of Dentistry Orthodontic Clinic
Participants in the study will be patients who are in orthodontic treatment or will start orthodontic treatment subjects must have full fixed appliances with brackets bonded to the buccal surfaces of the maxillary and mandibular incisors canines and first bicuspids Subjects will be of moderate or high caries risk according to Caries Risk Assessment and ATP Adenosine triphosphate bacteria testing Subjects will present with at least two active white spot lesions on hisher anterior teeth at the start of the study The age limitation is 11 years
The subjects will be randomly assigned to 1 Experimental group MI Varnish and MI Paste Plus or 2 Control standard of care group 1100 ppm Fluoride tooth paste and recommendation to use OTC Over-the-counter Fluoride-rinse in the evening at home
The clinical study investigator will evaluate the labialbuccal surfaces of upper and lower anterior teeth first bicuspid to first bicuspid for white spot lesions WSL at baseline and at the end of 3 6 and 12 months Newly formed lesions and changes in existing white spot lesions will be documented using Enamel Decalcification Index EDI ICDAS II light digital photographs and blue fluorescence photography SOPROLIFE and QLF- Quantitative Light Fluorescence
All subjects will receive one professional tooth cleaning at baseline and at each other evaluation office visit to allow WSL evaluation cleaning with ultrasonic device and prophylaxis brush and treatment application
Participants in the study will be patients who are in orthodontic treatment or will start orthodontic treatment subjects must have full fixed appliances with brackets bonded to the buccal surfaces of the maxillary and mandibular incisors canines and first bicuspids Subjects will be of moderate or high caries risk according to Caries Risk Assessment and ATP Adenosine triphosphate bacteria testing Subjects will present with at least two active white spot lesions on hisher anterior teeth at the start of the study The age limitation is 11 years
The subjects will be randomly assigned to 1 Experimental group MI Varnish and MI Paste Plus or 2 Control standard of care group 1100 ppm Fluoride tooth paste and recommendation to use OTC Over-the-counter Fluoride-rinse in the evening at home
The clinical study investigator will evaluate the labialbuccal surfaces of upper and lower anterior teeth first bicuspid to first bicuspid for white spot lesions WSL at baseline and at the end of 3 6 and 12 months Newly formed lesions and changes in existing white spot lesions will be documented using Enamel Decalcification Index EDI ICDAS II light digital photographs and blue fluorescence photography SOPROLIFE and QLF- Quantitative Light Fluorescence
All subjects will receive one professional tooth cleaning at baseline and at each other evaluation office visit to allow WSL evaluation cleaning with ultrasonic device and prophylaxis brush and treatment application
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None