In-situ Evaluation of Anti-caries Technology | NCT01650493

Studies
In-situ Evaluation of Anti-caries Technology

NCT01650493

Sponsor

Solventum US LLC

Status

Completed

Last Update Posted

Oct 2, 2024Actual

Enrollment

29Actual

Phase

Not provided

Conditions

Caries

Interventions

Clinpro 5000
MI Paste Plus
Tom's of Maine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

May 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Jun 14, 2012

First Submission Date that Met QC Criteria

Jul 25, 2012

First Posted Date

Jul 26, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2024

Last Update Posted Date

Oct 2, 2024Actual

Name	Class
University of Iowa	OTHER
3M	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Objective is to evaluate the demineralization and remineralization effects of two experimental fluoride containing dentrifices on enamel and root surface lesions compared with a control dentrifice.

Study is a partially randomized, 3-period cross over study involving 30 subjects who need a full-coverage crown on a posterior tooth. Each subject will use each of the study dentrifices over 3 months according to a randomization scheme. Subjects will brush daily with the assigned dentrifice unsupervised. Subjects will each have two provisonal crowns for use during the study. These crowns will contain three hard tooth tissue sections located at interproximal sites. The three tooth tissue slabs will consist of an artificial enamel caries lesion, an artificial root caries lesion, and a sound root. After removal, the tooth slabs will be evaluated using polarized light and photomicrographs for changes in area and depth of lesions.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Clinpro 5000	Device	Dentrifice containing 950ppm fluoride	Group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clark Stanford, PhD	Dows Institute for Dental Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dows Institute for Dental Research		Iowa City	Iowa	52242	United States