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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Chewing a Calcium Supplement Before Fluoride Rinse on Salivary Fluoride

NCT04620252

Dental Caries

COMPLETED EARLY_PHASE1

Evaluation of the Anti-cavity Efficacy of Three Dentifrices Using an Intra-oral Enamel Demineralization - Remineralization In-Situ Model

NCT06732518

Enamel Lesions Demineralization, Tooth Remineralization +1 more

COMPLETED PHASE3

Anti-caries Potential of a Sodium Monofluorophosphate and Calcium Sodium Phosphosilicate Dentifrice

NCT01657877

Caries

COMPLETED PHASE2

Caries-preventive Effect of a Dentifrice Containing 5,000 Ppm Fluoride in Orthodontic Patients

NCT01768390

Dental Caries

COMPLETED PHASE4

Dentifrice With Innovative Remineralizing Technology

NCT04730908

Initial Dental Caries

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dental Caries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

dentifrice intervention

4 types of dentifrices were used in 4 different periods in a crossover study design.

Group Type EXPERIMENTAL

calcium glycerophosphate

Intervention Type DRUG

use of a dentifrice containing CaGP (0.13%) and no fluoride

no active ingredient

Intervention Type DRUG

dentifrice without calcium glycerophosphate and no fluoride

fluoride

Intervention Type DRUG

use of a dentifrice containing fluoride (1500ppm) only

CAGP + fluoride

Intervention Type DRUG

calcium glycerophosphate and fluoride dentifrice

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

calcium glycerophosphate

use of a dentifrice containing CaGP (0.13%) and no fluoride

Intervention Type DRUG

no active ingredient

dentifrice without calcium glycerophosphate and no fluoride

Intervention Type DRUG

fluoride

use of a dentifrice containing fluoride (1500ppm) only

Intervention Type DRUG

CAGP + fluoride

calcium glycerophosphate and fluoride dentifrice

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CaGP dentifrice only (placebo) sodium fluoride Experimental dentifrice with CAGP + fluoride

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* to live in a non-fluoridated area
* to have at least 20 natural teeth
* signed a consent form agreeing to carefully follow the research instructions