A Randomized, Single-Blind, Cross-Over Clinical Study to Assess an Experimental Dentifrice in an in situ Model of Early Stage Caries (26428 )

A
Anderson Hara, DDS

Primary Investigator

Enrolling By Invitation
18 years - 85 years
All
Phase N/A
45 participants needed
1 Location

Brief description of study

What is the purpose of this study?

The purpose of this study is to investigate how well an experimental toothpaste will be in promoting tooth enamel remineralization (hardening), stopping tooth enamel softening and measuring the fluoride uptake into tooth enamel in comparison with a fluoride-free toothpaste and with a marketed fluoride-containing toothpaste.  

THIS STUDY IS ENROLLING BY INVITATION ONLY - All subjects participating in this study will have already been accepted into the partial denture panel (IRB 18515). They will be contacted directly by the study team about study participation. 

Detailed description of study

What will happen during the study?

Softened tooth specimens will be placed in the participant's lower partial denture that they will wear 24 hours a day for three separate two-week test periods..

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Healthy, Mandibular partial denture
  • Age: 18 years - 85 years
  • Gender: All

Inclusion Criteria:
An individual must meet all the following inclusion criteria to be eligible for enrollment into,
and continuance in the study:
1. Subject provision of a signed and dated informed consent document indicating that the
subject has been informed of all pertinent aspects of the study before any assessment is
performed.
2. Subject is of either sex and any gender who, at the time of screening, is between the ages
of 18-85 years, inclusive.
3. Subject is willing and able to comply with scheduled visits, and other study procedures
and restrictions.
4. Subject is in good general and mental health with, in the opinion of the investigator or
medically qualified designee, no clinically significant or relevant abnormalities in
medical history or upon oral examination, or condition, that would impact the subject’s
safety, wellbeing or the outcome of the study, if they were to participate in the study, or
affect the individual’s ability to understand and follow study procedures and
requirements.
5. Subject who demonstrates a salivary flow-rate in the range of normal values
(unstimulated whole saliva flow-rate ≥ 0.2 g/minute (min); gum base stimulated whole
saliva flow-Rate ≥ 0.8 g/min).
6. Subject with a RPD fulfilling:
a. Wears a removable mandibular partial denture that has good stability and support,
with sufficient room on one side in the posterior teeth/buccal flange area to
accommodate two enamel specimens (required dimensions approximately 5mm in
diameter and 2.5mm deep for each specimen site).
b. Willing to have their denture modified to accommodate the enamel test specimens.
c. Willing and capable of wearing their removable partial dentures 24 hours per day
during each 14-day treatment period.
d. Willing and capable of brushing their natural teeth with the lower partial denture in
place.
e. Willing to cease using all denture cleaners and fixatives on their mandibular RPD
during the study (with the exception of the supplied non-zinc fixative which may be
used on any maxillary denture if present and required).

Exclusion Criteria:
1. Subject who is an employee of the investigational site, either directly involved in the
conduct of the study or a member of their immediate family; or an employee of the
investigational site otherwise supervised by the investigator; or, a Haleon employee
directly involved in the conduct of the study or a member of their immediate family.
2. Subject who has participated in other studies (including non-medicinal studies) involving
investigational product(s) within 30 days prior to study entry and/or during study
participation.
3. Subject with, in the opinion of the investigator or medically qualified designee, an acute
or chronic medical or psychiatric condition or laboratory abnormality that may increase
the risk associated with study participation or investigational product administration or
may interfere with the interpretation of study results and, in the judgment of the
investigator or medically qualified designee, would make the subject inappropriate for
entry into this study.
4. Subject who is pregnant (self-reported) or intending to become pregnant over the duration
of the study or who is breastfeeding.
5. Subject with known or suspected intolerance or hypersensitivity to the study materials (or
closely related compounds) or any of their stated ingredients.
6. Subject who, in the opinion of the investigator or medically qualified designee, has a
condition or medical history that would impact on their safety or wellbeing or affect their
ability to understand and follow study procedures and requirements or who should not
participate in the study for other reasons.
7. Subject with a recent history (within the last year) of alcohol or other substance abuse.
8. Subject requiring the need for antibiotic premedication prior to a dental prophylaxis or
taking some blood thinning medications that prohibit the safe conduct of a dental
cleaning. Note: Medical consultation may need to be obtained from subject’s physician at
the examiner’s discretion.
9. Subject who is:-
a. Taking antibiotics or has taken antibiotics in the two weeks prior to the screening
visit.
b. Taking or has ever taken a bisphosphonate drug (i.e. Fosamax, Actonel Boniva,
Reclast, or Zometa).
c. Using or intending to use professionally recommended fluoride supplements or
fluoride mouth rinse, or has received a professional fluoride application in the 2
weeks prior to screening.
10. Subject who has:
a. Active caries or dental restorations in a poor state of repair (in the opinion of the
examiner) that could impact subject safety or efficacy evaluations.
b. Moderate or severe periodontal disease that may compromise the study or health of
the subjects. Subjects presenting at screening with minor caries may continue in the
study if their carious lesions are repaired prior to the start of the first treatment
period.
10. Subject who has previously been enrolled in this study. 

Updated on 08 Apr 2025. Study ID: OHRI-HALEON-ASTRO, 26428
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