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Clinical Study to Evaluate Remineralization Using an in Situ Model.

ConditionsRemineralizationEnamel LesionsEnamel Subsurface Lesion
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorColgate Palmolive

About this trial

This is a phase III clinical trial that aims to evaluate the enamel remineralization efficacy of three dentifrices on artificial caries lesions using an in situ model. The study involves 30 healthy volunteers, aged 18 to 70, who will participate in a randomized, triple-blind, three-period crossover design. Researchers will compare a 750 ppm MFP dentifrice against a 1450 ppm MFP positive control and a fluoride-free negative control to measure variations in mineral gain. Participants will wear a removable intraoral appliance containing human enamel blocks for three 14-day experimental phases. A 7-day washout period using will be implemented before and between each treatment phase.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Males and females, between 18-70 years of age (inclusive);

Informed Consent Form signed and availability for the duration of the study;

Good general health (absence of any condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study. Examples include heart problems, valve/hip replacements, etc);

Willingness to provide information related to their medical history;

Disqualifiers

Oral pathology, chronic disease, or a history of allergy to testing products;

Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study;

Subject participating in any other clinical study;

Subject pregnant or breastfeeding;

Trial design

Design model

Crossover

Treatments tested in this trial

  • Fluoride toothpaste containing 750 ppm MFP in a Dical base

    Drug

    Subjects will brush using a fluoride toothpaste containing 750 ppm MFP in a Dical base and a soft bristle toothbrush for 14 days

  • Fluoride toothpaste containing 1450 ppm MFP in a Dical base

    Drug

    Subjects will brush using a fluoride toothpaste containing 1450 ppm MFP in a Dical base and a soft bristle toothbrush for 14 days

  • Fluoride-free toothpaste in a Dical base

    Drug

    Subjects will brush using a fluoride-free toothpaste in a Dical base and a soft bristle toothbrush for 14 days

  • Toothbrush

    Device

    A commercially available adult soft bristle toothbrush

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Test GroupExperimental treatment 2 interventions
Group B: Positive Control GroupActive comparator 2 interventions
Group C: Negative Control GroupSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in integrated mineral loss (Δz)

Integrated mineral loss (Δz) will be assessed by transverse microradiography (TMR). This outcome will evaluate the change from the baseline demineralized state (Δz0) to the post-treatment state (Δz1) to quantify the net mineral gain or loss.

Time frame
9 weeks

Secondary outcomes

1

Change in lesion depth

Post-treatments lesion depth (LD) will be assessed by TMR. For each experimental phase, post-treatment values will be compared with corresponding baseline measurements to determine the extent of remineralization.

Time frame
9 weeks
2

Change from Baseline in Fluorescence Loss

Fluorescence loss ΔF, will be assessed by quantitative light-induced fluorescence (QLF) to measure the percentage loss of fluorescence intensity. The change will be calculated by comparing post-treatment values at 9 weeks with baseline measurements.

Time frame
9 weeks
3

Change from Baseline in Maximum Fluorescence Loss ΔFmax at 9 Weeks

Maximum fluorescence loss ΔFmax at the deepest point of the lesion will be assessed by quantitative light-induced fluorescence (QLF). The change will be calculated by comparing post-treatment values at 9 weeks with baseline measurements.

Time frame
9 weeks
4

Change from Baseline in Fluorescence Loss Volume (ΔQ) at 9 Weeks

Fluorescence loss volume (ΔQ) will be assessed by quantitative light-induced fluorescence (QLF). The change will be calculated by comparing post-treatment values at 9 weeks with baseline measurements.

Time frame
9 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Colgate Palmolive

Lead sponsor

Federal University of Paraíba

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: