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| ID | Type | Description | Link |
|---|---|---|---|
| CNPq?PIBIC?UFPB_2005 |
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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento Científico e Tecnológico | OTHER_GOV |
| Coordination for the Improvement of Higher Education Personnel | OTHER |
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The aim of this study was to investigate the buffering effect of a calcium glycerophosphate-fluoride (CaGP-F) dentifrice on in vivo dental biofilm after a cariogenic challenge and evaluate its probable 12-hour protective effect. Twelve young adults took part in this randomized, double blind, 14-day 4-phase crossover study. Between each phase, the volunteers had a 1-week wash-out period. Coded dentifrices were randomly assigned to the volunteers: A) no F and no CaGP; B) CaGP-only (0.13%); C) F-only (1500 ppm (ppm= parts per million of fluoride which is equivalent to mg/kg)); D) CaGP-F (0.13%, 1500 ppm, respectively). The pH measurements were taken from a single-site using a microelectrode, with salt bridge established by a 1M KCl (one molar potassium chloride) solution with a reference electrode. pH measurements were taken at 0 (baseline), 1, 7, 14 and 21 min (minutes) after a cariogenic challenge (10% w/v sucrose solution, %w/v = percent weight per volume). Four sets of measurements were carried out: (D0BS) before test dentifrice usage; (D01min) 1-min after test dentifrice usage; and (D712h) 7 days and (D1412h) 14 days using the test dentifrice, 12 hours (h)after brushing. Stephen curves and mean AUC (area under the curve) were obtained.
Although the mechanisms of action of fluoride are reasonably understood, the mechanism of calcium phosphate and calcium glycerophosphate (CaGP) are still a matter of debate. It has been suggested that CaGP increases the phosphorus content in the biofilm and, as a result, the buffering capacity of the biofilm is intensified. The pH levels of the biofilm are maintained above the 5.0-5.5 range. This is above the critical range for enamel demineralization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dentifrice intervention | Experimental | 4 types of dentifrices were used in 4 different periods in a crossover study design. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| calcium glycerophosphate | Drug | use of a dentifrice containing CaGP (0.13%) and no fluoride |
|
| Measure | Description | Time Frame |
|---|---|---|
| Minimum pH | 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. | at 1 minute (minimum fermenting pH) or at 7 minutes |
| Minimum pH After 14 Days of Use of Dentifrice | measurement of pH obtained as described before. However, this time the biofilm was exposed to the dentifrices for a longer period (14 days). | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabio C Sampaio, PhD | Federal University of Paraiba | Principal Investigator |
| Thiago S Carvalho, Master | Federal University of Paraiba | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Science Centre at the Federal University of Paraiba | João Pessoa | Paraíba | 58051900 | Brazil |
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.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo Dentifrice |
| |||||||||||||
| CaGP Only Dentifrice |
| |||||||||||||
| Fluoride Only Dentifrice |
| |||||||||||||
| CaGP and Fluoride Dentifrice |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Minimum pH | 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. | 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. | Posted | Mean | Standard Deviation | pH | at 1 minute (minimum fermenting pH) or at 7 minutes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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pH measurements of dental biofilms were difficult after continuous use of dentifrice because of reduced biofilm mass in contrast to baseline measurements.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fabio Correia Sampaio (research leader) | Federal University of Paraiba | +55 83 3216 7795 | fabios@ccs.ufpb.br |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D005994 | Glycerophosphates |
| D005459 | Fluorides |
| D012969 | Sodium Fluoride |
| ID | Term |
|---|---|
| D000073999 | Triose Sugar Alcohols |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| no active ingredient | Drug | dentifrice without calcium glycerophosphate and no fluoride |
|
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| fluoride | Drug | use of a dentifrice containing fluoride (1500ppm) only |
|
|
| CAGP + fluoride | Drug | calcium glycerophosphate and fluoride dentifrice |
|
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Calcium Glycerophosphate | intervention of using a dentifrice containing only calcium glycerophosphate (CaGP) |
| OG002 | Fluoride | intervention of using a dentifrice with 1,500 ppm of fluoride |
| OG003 | Calcium Glycerophosphate and Fluoride | intervention of using a dentifrice containing fluoride and calcium glycerophosphate |
|
|
|
| Primary | Minimum pH After 14 Days of Use of Dentifrice | measurement of pH obtained as described before. However, this time the biofilm was exposed to the dentifrices for a longer period (14 days). | The initial part of the work as a pilot study. | Posted | Mean | Standard Deviation | pH | 14 days |
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| 0 |
| 0 |
| 0 |
| 0 |
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| D002241 |
| Carbohydrates |
| D013403 | Sugar Phosphates |
| D010743 | Phospholipids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D017670 | Sodium Compounds |
| D002327 | Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |