Trial Outcomes & Findings for Effect of Calcium Glycerophosphate (CaGP) - Fluoride Dentifrice on Dental Biofilm pH (NCT NCT00875212)

Last Updated: 2009-10-15

Results Overview

The dental biofilm pH was measured in vivo with the microtouch method, using a palladium microelectrode + reference electrode. Data represents the mean values of the lowest pH observed each time after the use of sucrose.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

12 participants

Primary outcome timeframe

at 1 minute (minimum fermenting pH) or at 7 minutes

Results posted on

2009-10-15

Participant Flow

The subjects were dental students of the University. The recruitment locations were dental clinics of the faculty and laboratory facilities. The dates of recruitment included 2-3 months before starting the research in January 2006; and lasted for 2 months afterwards

As a pre-assignment procedure, all volunteers signed an informed consent. The the volunteers received a dental hygiene kit containing a toothbrush and a fluoride-free and calcium-free dentifrice as part of the 1-week wash-out period prior to group assignment.

Participant milestones

Participant milestones
Measure	Toothbrushing The study was based on the use of dentifrices for daily oral hygiene in a crossover design. The volunteers were asked to use the placebo and test dentifrices for one week. During the study, the volunteers were instructed to brush their teeth normally until 3 days before the measurements. During these 3 days, they were instructed to brush only the occlusal surfaces of their teeth until 12 hours before the pH measurements, when they should stop brushing altogether for dental plaque pH evaluation.
Placebo Dentifrice STARTED	12
Placebo Dentifrice COMPLETED	12
Placebo Dentifrice NOT COMPLETED	0
CaGP Only Dentifrice STARTED	12
CaGP Only Dentifrice COMPLETED	12
CaGP Only Dentifrice NOT COMPLETED	0
Fluoride Only Dentifrice STARTED	12
Fluoride Only Dentifrice COMPLETED	12
Fluoride Only Dentifrice NOT COMPLETED	0
CaGP and Fluoride Dentifrice STARTED	12
CaGP and Fluoride Dentifrice COMPLETED	12
CaGP and Fluoride Dentifrice NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Calcium Glycerophosphate (CaGP) - Fluoride Dentifrice on Dental Biofilm pH

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Toothbrushing n=12 Participants The study was based on the use of dentifrices for daily oral hygiene in a crossover design. The volunteers were asked to use the placebo and test dentifrices for one week. During the study, the volunteers were instructed to brush their teeth normally until 3 days before the measurements. During these 3 days, they were instructed to brush only the occlusal surfaces of their teeth until 12 hours before the pH measurements, when they should stop brushing altogether for dental plaque pH evaluation.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	26 years STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment Brazil	12 participants n=5 Participants

PRIMARY outcome

Timeframe: at 1 minute (minimum fermenting pH) or at 7 minutes

Population: The number of subjects were determined by a pilot study carried out in 3 volunteers. The study has a crossover design. Thus the 4 groups of dentifrices tested included the same subjects in a different time-measurement avoiding the influence of individual variables in the analysis.

Outcome measures

Outcome measures
Measure	Control n=12 Participants intervention of using a dentifrice of no active ingredient. The volunteers were asked to use the placebo dentifrices for one week. Throughout the study, the volunteers were instructed to brush their teeth normally up until 3 days before the measurements. During these 3 days, they were instructed to brush only the occlusal surfaces of their teeth until 12 hours before the pH measurements, when they should stop brushing altogether for dental plaque pH evaluation.	Calcium Glycerophosphate n=12 Participants intervention of using a dentifrice containing only calcium glycerophosphate (CaGP)	Fluoride n=12 Participants intervention of using a dentifrice with 1,500 ppm of fluoride	Calcium Glycerophosphate and Fluoride n=12 Participants intervention of using a dentifrice containing fluoride and calcium glycerophosphate
Minimum pH	5.40 pH Standard Deviation 0.60	5.48 pH Standard Deviation 0.65	5.25 pH Standard Deviation 0.77	5.70 pH Standard Deviation 0.43

PRIMARY outcome

Timeframe: 14 days

Population: The initial part of the work as a pilot study.

measurement of pH obtained as described before. However, this time the biofilm was exposed to the dentifrices for a longer period (14 days).

Outcome measures

Outcome measures
Measure	Control n=12 Participants intervention of using a dentifrice of no active ingredient. The volunteers were asked to use the placebo dentifrices for one week. Throughout the study, the volunteers were instructed to brush their teeth normally up until 3 days before the measurements. During these 3 days, they were instructed to brush only the occlusal surfaces of their teeth until 12 hours before the pH measurements, when they should stop brushing altogether for dental plaque pH evaluation.	Calcium Glycerophosphate n=12 Participants intervention of using a dentifrice containing only calcium glycerophosphate (CaGP)	Fluoride n=12 Participants intervention of using a dentifrice with 1,500 ppm of fluoride	Calcium Glycerophosphate and Fluoride n=12 Participants intervention of using a dentifrice containing fluoride and calcium glycerophosphate
Minimum pH After 14 Days of Use of Dentifrice	4.78 pH Standard Deviation 0.67	5.24 pH Standard Deviation 0.83	5.25 pH Standard Deviation 0.71	5.44 pH Standard Deviation 0.59

Adverse Events

Toothbrushing

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

Fabio Correia Sampaio (research leader)

Federal University of Paraiba

Phone: +55 83 3216 7795

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place