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Effectiveness of Toothpaste Tablets on Plaque, Gingival Health and Caries Experiences

ConditionsGingival InflammationDental Caries
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorLoma Linda University

About this trial

Objectives: To evaluate the effectiveness of toothpaste tablets when compared to conventional dentifrices in removing plaque.

Methods: 50 participants are randomized into two groups: Denttabs toothpaste tablets (T) and Colgate's Cavity Protection toothpaste (P). Both groups utilize their assigned dentifrice for 6 weeks. A pre and post-assessment measures the Gingival Index (GI) and Plaque Index (PI) and Decayed, Missing and Filled Teeth (DMFT). A questionnaire on the use of the product is distributed at the end of the study.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Subjects are 18 years or older;

Subjects who will comply with study protocol;

Subjects who can read and understand the consent form;

Subjects available during the study period;

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Toothpaste Tablet

    Drug

    Denttabs toothpaste tablets

  • Conventional Toothpaste

    Drug

    Colgate Cavity Protection toothpaste

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Toothpaste TabletExperimental treatment 1 intervention
Group B: Conventional ToothpasteActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Plaque Index Score at Baseline

The quantity of plaque build-up is measured visually using the Quigley-Hein Plaque Index. The Plaque index can range from 0 to 5, with higher numbers indicating more plaque build-up.

Time frame
Change between baseline at visit 1 and visit 2, six weeks post baseline
2

Gingival Index Score at Baseline

The severity of gingival inflammation is measured visually using the Loe-Silness Gingival Index. Gingival index can range from 0 to 3, with higher numbers indicating more gingival inflammation.

Time frame
Change between baseline at visit 1 and visit 2, six weeks post baseline

Secondary outcomes

1

DMFT Score at Baseline

Caries experiences is measured visually using the DMFT index. DMFT score can range from 0 to 28, with higher numbers indicating higher caries experiences.

Time frame
Change between baseline at visit 1 and visit 2, six weeks post baseline
2

Subject Perception of Product Use

The perception on the product usage is measured using a survey containing questions on feel, texture, flavor, ease of use, eco-friendliness, cost and overall satisfaction. Response is on a 4 point Likert scale ranging from strongly agree (1) to strongly disagree (4).

Time frame
Visit 2 six weeks post study enrollment

Other outcomes

Sponsors and contacts

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

Loma Linda University

Lead sponsor

Source ClinicalTrials.gov

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