In-situ Evaluation of Anti-caries Technology

NCT01650493 | Completed

• 1 other identifier: CR-11-012
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Three toothpastes will be compared, two toothpastes in each subject, to establish whether changes in the depth or area of an artificially created area of tooth decay is the same for each toothpaste.

Conditions

Caries

Keywords

remineralization; demineralzation; in situ; dentrifice

Outcome Measures

Primary Outcomes (2)

• Change in depth of artificial lesion over 3 months

  Comparison of two 950 ppm fluoride containing dentrifices, Clinpro Toothcreme and MI Paste Plus, with fluoride-free dentrifice (Toms of Maine)for any change in artificial lesion depth due to demineralization or remineralization over the time period of the study

  3 months

• Change in area of artificial lesion over 3 months

  Comparison of two 950 ppm fluoride containing dentrifices, Clinpro 5000 and MI Paste Plus, with fluoride-free dentrifice (Toms of Maine) for any change in artificial lesion area due to demineralization or remineralization over time period of study

  3 months

Study Arms (3)

Group A

Clinpro 5000

Device: Clinpro 5000

Group B

MI Paste Plus

Device: MI Paste Plus

Group C

Toms of Maine

Device: Tom's of Maine

Interventions

Clinpro 5000 DEVICE

Dentrifice containing 950ppm fluoride

Group A

MI Paste Plus DEVICE

Dentrifice containing 950ppm fluoride

Group B

Tom's of Maine DEVICE

Dentrifice that is fluoride free

Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Generally healthy subjects in need of a full-coverage crown on a mandibular first or second molar

You may qualify if:

• generally good physical health
• at least 18 years old
• needs a full crown on a mandibular first or second molar tooth
• tooth brushing frequency of twice daily or more
• agrees not to participate in other clinical study for duration of this study
• agrees to delay any elective dentistry, including dental prophylaxis, until study complete

You may not qualify if:

• any condition requiring antibiotic premedication before a dental procedure
• active treatment for cancer or seizure disorder
• diseases or conditions that could interfere with subject safely completing the study
• currently taking antibiotics or anti-cholinergic medications
• currently using extensive daily fluoride therapy
• gross, visible caries
• chronic use of chlorhexidine within 3 months of baseline
• use of systemic antibiotics within 7 days of baseline
• severe periodontal disease
• use of any fluoride rinses or gels one month prior to study initiation
• pregnancy, the intention to become pregnant
• presence of orthodontic bands or removable retainers

Sponsors & Collaborators

• Solventum US LLC: lead
• University of Iowa: collaborator
• 3M: collaborator

Study Sites (1)

Dows Institute for Dental Research

Iowa City, Iowa, 52242, United States

Location

Study Officials

• Clark Stanford, PhD

  Dows Institute for Dental Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2012
• First Posted: July 26, 2012
• Study Start: June 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 2, 2024

Record last verified: 2024-09

Locations

US (1)