Evaluating the effectiveness of three types of toothpaste on tooth enamel health
Clinical Study to Evaluate the Anti-cavity Efficacy of Three Dentifrices Using an Intra-oral Enamel Demineralization - Remineralization In-Situ Model
This study is testing whether three different types of toothpaste can help improve tooth enamel health in adults aged 18 to 70.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Colgate Palmolive Industry-sponsored |
| Locations | 1 site (Maceió, AL) |
| Trial ID | NCT06732518 on ClinicalTrials.gov |
What this trial studies
This clinical study assesses the anti-cavity efficacy of three different dentifrices using an intra-oral enamel demineralization-remineralization model. It is a Phase III, randomized, triple-blind, crossover study involving 36 participants aged 18 to 70. Participants will use an intra-oral appliance with bovine enamel blocks and will be divided into three treatment groups, each using a different type of toothpaste over a 6-week period, with washout phases in between. The primary outcome measured will be the changes in enamel microhardness before and after treatment.
Who should consider this trial
Good fit: Ideal candidates are healthy males and females aged 18 to 70 with at least 20 uncrowned permanent natural teeth.
Not a fit: Patients with oral pathology, chronic diseases, or those allergic to the testing products may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dental care products that better protect against cavities and enhance tooth enamel health.
How similar studies have performed: Previous studies have shown varying degrees of success with similar approaches in evaluating dental products, but this specific combination of treatments is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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; * Minimum of 20 uncrowned permanent natural teeth (excluding third molars); Normal salivary flow; * Willingness to wear an intra-oral appliance all day as instructed except when eating and drinking. Exclusion Criteria: * 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; * Subject allergic to oral care products, personal care consumer products, or their ingredients; * Extended use of antibiotics or therapeutic mouthwash any time during the three months prior to entry into the study; * A medical history reporting that the subject has a current systemic or autoimmune disease, such as diabetes, lupus, etc.; * Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine); * Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone). Pocket depth equal or greater than 4 mm * Five or more decayed, untreated dental sites (cavities); * Current smokers and subjects with a history of alcohol or drug abuse; * Dental work prevents wearing of the appliance or a reported need to wear a night guard.
Where this trial is running
Maceió, AL
- Federal University of Alagoas — Maceió, Al, Brazil (Recruiting)
Study contacts
- Principal investigator: Natanael Silva, PhD — Federal University of Alagoas
- Study coordinator: Natanael Santos, PhD
- Email: natanael.santos@foufal.ufal.br
- Phone: +55 82 999191482
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.