Clinical trial NCT01604109: Effect of CPP-ACP Paste on Dental Caries in Primary Teeth
Official title: Effect of CPP-ACP Paste on Dental Caries in Primary Teeth: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dental Caries
Keywords: Caries detection/diagnosis/prevention
Preventive Dentistry
Casien Phosphopeptide
Remineralization
Clinical trial
Lead sponsor: Thammasat University
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
First posted: 2012-05-23
Enrollment: 296
Sex: ALL
Minimum age (years): 30
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if adding daily application of CPP-ACP containing paste for one year is superior to regular fluoride tooth brushing in preventing dental caries in high caries risk Thai preschool children.

Detailed description: The 6th National Oral Health Survey in Thailand 2006-2007 reported that 3-year-old children who resided in central part have the highest dental caries prevalence of 69.8 percent with dmft affecting 3.63 teeth on average. Fluoride is widely accepted as the most effective tool to caries prevention for initial caries lesions. Current best practice recommends twice-daily tooth brushing with fluoride toothpaste for dentate children.

CPP-ACP can bolster the effects of fluoridated toothpaste alone to prevent caries.Currently, almost all clinical trials have investigated the effectiveness of CPP-ACP containing products in dental caries prevention and enhancing remineralization of initial carious lesion in the permanent dentition of young adolescents. There are no clinical studies of the effect of a CPP-ACP containing product to prevent dental caries in the primary dentition of young children.

Eligibility criteria: Inclusion Criteria:

* Healthy Thai boys and girl aged between 2 1/2 - 3 1/2
* Normal development of dentition
* Diagnosed as high caries risk by using the Caries-risk Assessment Tool(CAT)

Exclusion Criteria:

* Chronic use of medications or antibiotics.
* Lack of cooperation in oral examination
* Milk protein allergy and/or benzoate preservatives
* Presence at baseline oral soft tissue lesion and enamel hypoplasia.
* Receive fluoride supplement and professional topical fluoride application at least three months before the beginning of study or during study period

Primary outcomes:
measure: the Mean Number of Enamel Carious Lesion
timeFrame: one calender year
Secondary outcomes:
measure: Quantitative Light-induced Fluorescence (QLF) Parameters
timeFrame: one calender year
Other outcomes:
Locations:
city: Klongluang
country: Thailand
facility: Faculty of Dentistry, Thammasat University
state: Patumthani
Study officials:
affiliation: Faculty of Dentistry, Thammasat University
name: Thanya Sitthisettapong
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sitthisettapong T, Phantumvanit P, Huebner C, Derouen T. Effect of CPP-ACP paste on dental caries in primary teeth: a randomized trial. J Dent Res. 2012 Sep;91(9):847-52. doi: 10.1177/0022034512454296. Epub 2012 Jul 17.