Trial Outcomes & Findings for Effect of CPP-ACP Paste on Dental Caries in Primary Teeth (NCT NCT01604109)

Results Overview

tooth surface that was classified as ICDAS code 1-3

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

296 participants

Primary outcome timeframe

one calender year

Results posted on

2013-08-15

Participant Flow

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.

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).

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	150	146
Overall Study COMPLETED	117	112
Overall Study NOT COMPLETED	33	34

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tooth Mousse n=150 Participants 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 n=146 Participants 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 n=296 Participants Total of all reporting groups
Age, Categorical <=18 years	150 Participants n=5 Participants	146 Participants n=7 Participants	296 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	3.08 years STANDARD_DEVIATION 0.24 • n=5 Participants	3.10 years STANDARD_DEVIATION 0.25 • n=7 Participants	3.09 years STANDARD_DEVIATION 0.24 • n=5 Participants
Sex: Female, Male Female	78 Participants n=5 Participants	75 Participants n=7 Participants	153 Participants n=5 Participants
Sex: Female, Male Male	72 Participants n=5 Participants	71 Participants n=7 Participants	143 Participants n=5 Participants
Region of Enrollment Thailand	150 participants n=5 Participants	146 participants n=7 Participants	296 participants n=5 Participants

PRIMARY outcome

Timeframe: one calender year

tooth surface that was classified as ICDAS code 1-3

Outcome measures

Outcome measures
Measure	Tooth Mousse n=150 Participants 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 n=146 Participants 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.
the Mean Number of Enamel Carious Lesion	13.69 Surfaces Standard Deviation 7.94	14.55 Surfaces Standard Deviation 9.56

SECONDARY outcome

Timeframe: one calender year

percent fluorescence loss, lesion area, lesion volume

Outcome measures

Outcome data not reported

Adverse Events

Tooth Mousse

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Control Paste

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Thanya Sitthisettapong

ThammasatU

Phone: 6629869213

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place