ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of CPP-ACP Paste on Dental Caries in Primary Teeth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01604109
Recruitment Status : Completed
First Posted : May 23, 2012
Results First Posted : August 15, 2013
Last Update Posted : August 15, 2013
Sponsor:
Collaborator:
John E. Fogarty International Center (FIC)
Information provided by (Responsible Party):
Thanya Sitthisettapong, Thammasat University

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Dental Caries
Interventions: Drug: 10 % w/v CPP-ACP paste
Drug: the paste without CPP-ACP

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study took place in the central part of Thailand, where water [F]<0.1 ppm. The recruitment began in June 2010. There were 304 healthy Thai boys and girls from ten public nursery schools enrolled in the study. The baseline examination was performed at school in July-August, 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Six children were excluded from the study because they did not complete the inclusion criteria: autism (1), milk protein allergy (1), taking fluoride table (1), and no high caries risk (3).

Reporting Groups
  Description
Tooth Mousse

10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste

10 % w/v CPP-ACP paste : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch

Placebo Control Paste

the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate

the paste without CPP-ACP : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch.


Participant Flow:   Overall Study
    Tooth Mousse   Placebo Control Paste
STARTED   150   146 
COMPLETED   117   112 
NOT COMPLETED   33   34 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Tooth Mousse

10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste

10 % w/v CPP-ACP paste : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch

Placebo Control Paste

the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate

the paste without CPP-ACP : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch.

Total Total of all reporting groups

Baseline Measures
   Tooth Mousse   Placebo Control Paste   Total 
Overall Participants Analyzed 
[Units: Participants]
 150   146   296 
Age 
[Units: Participants]
     
<=18 years   150   146   296 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 3.08  (0.24)   3.10  (0.25)   3.09  (0.24) 
Gender 
[Units: Participants]
     
Female   78   75   153 
Male   72   71   143 
Region of Enrollment 
[Units: Participants]
     
Thailand   150   146   296 


  Outcome Measures

1.  Primary:   the Mean Number of Enamel Carious Lesion   [ Time Frame: one calender year ]

2.  Secondary:   Quantitative Light-induced Fluorescence (QLF) Parameters   [ Time Frame: one calender year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This one year study was performed on high caries risk pre-school children who enrolled in government nursery schools in central part of Thailand.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Thanya Sitthisettapong
Organization: ThammasatU
phone: 6629869213 ext 7150
e-mail: thanyasang@yahoo.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Thanya Sitthisettapong, Thammasat University
ClinicalTrials.gov Identifier: NCT01604109     History of Changes
Other Study ID Numbers: TU-Dent-01
D43TW007768 ( U.S. NIH Grant/Contract )
First Submitted: May 19, 2012
First Posted: May 23, 2012
Results First Submitted: June 10, 2013
Results First Posted: August 15, 2013
Last Update Posted: August 15, 2013