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

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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
Enrollment 296
Recruitment Details 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 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).
Arm/Group Title Tooth Mousse Placebo Control Paste
Hide Arm/Group Description

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

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.

Period Title: Overall Study
Started 150 146
Completed 117 112
Not Completed 33 34
Arm/Group Title Tooth Mousse Placebo Control Paste Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 150 146 296
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 146 participants 296 participants
<=18 years
150
 100.0%
146
 100.0%
296
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 150 participants 146 participants 296 participants
3.08  (0.24) 3.10  (0.25) 3.09  (0.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 146 participants 296 participants
Female
78
  52.0%
75
  51.4%
153
  51.7%
Male
72
  48.0%
71
  48.6%
143
  48.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Thailand Number Analyzed 150 participants 146 participants 296 participants
150 146 296
1.Primary Outcome
Title the Mean Number of Enamel Carious Lesion
Hide Description tooth surface that was classified as ICDAS code 1-3
Time Frame one calender year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tooth Mousse Placebo Control Paste
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 150 146
Mean (Standard Deviation)
Unit of Measure: Surfaces
13.69  (7.94) 14.55  (9.56)
2.Secondary Outcome
Title Quantitative Light-induced Fluorescence (QLF) Parameters
Hide Description percent fluorescence loss, lesion area, lesion volume
Time Frame one calender year
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tooth Mousse Placebo Control Paste
Hide Arm/Group Description

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

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.

All-Cause Mortality
Tooth Mousse Placebo Control Paste
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tooth Mousse Placebo Control Paste
Affected / at Risk (%) Affected / at Risk (%)
Total   0/150 (0.00%)   0/146 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tooth Mousse Placebo Control Paste
Affected / at Risk (%) Affected / at Risk (%)
Total   0/150 (0.00%)   0/146 (0.00%) 
This one year study was performed on high caries risk pre-school children who enrolled in government nursery schools in central part of Thailand.
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
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