Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:23 PM
Study NCT ID:
NCT03488056
Status:
UNKNOWN
Last Update Posted:
2018-04-04
First Post:
2018-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of ICCMS in Reducing the Incidence of Dental Caries in Children
Sponsor:
University of Sao Paulo
Organization:
Study Overview
Official Title:
Effectiveness of the International Caries Classification and Management System (ICCMS) in Reducing the Incidence of Dental Caries in Children Attending to the CURUMIM Social Project, Sesc/São Paulo(SP)
Status:
UNKNOWN
Status Verified Date:
2018-04
Last Known Status:
RECRUITING
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:
None
Brief Summary:
The aim of the present study is to evaluate the effectiveness of using the ICCMS (International Caries Classification And Management System)in reducing caries lesions incidence compared to a control group that use different criteria as a not systematic and standardized prevention strategy. The study will be performed among children attending to the social project of Social Service of Commerce (SESC), Sao Paulo. The sample will be composed of 460 children aging between 7 to 12 years old registered in CURUMIM Program from eight dental centers of SESC. A randomized controlled study with parallel group will be conducted. The centers will be randomized between the 2 strategies, defining 2 groups with 4 centers each. The experimental group that will follow the criteria defined by the ICCMS will evaluate clinical and behavioral variables, it will define: evaluation of the caries risk of the patient, evaluation of the intraoral risk, diagnosis of the caries lesion and its respective activity, plan decision individualized treatment for the patient and indication of recall interval according to the risk of caries. In the control group, children need will be solved according to rthe routinely dental practices in the center, but the determination of the child's general and intraoral risk of developing new caries lesions will not be performed nor the scheduling of specific recall intervals according to the risk.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: