Clinical Evaluation of Three Dental Adhesive Systems in C... | NCT00643461

Studies
Clinical Evaluation of Three Dental Adhesive Systems in Class V Restorations

NCT00643461

Sponsor

Solventum US LLC

Status

Completed

Last Update Posted

Oct 2, 2024Actual

Enrollment

46Actual

Phase

Not provided

Conditions

Dental Caries

Interventions

Adhesive A
Adhesive B
Adhesive C

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

Apr 2008

Primary Completion Date

Feb 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Mar 20, 2008

First Submission Date that Met QC Criteria

Mar 25, 2008

First Posted Date

Mar 26, 2008Estimated

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
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

The purpose of this study is to compare the clinical performance of three dental adhesive systems used to bond Class V cavity fillings in adult teeth.

Detailed Description

Not provided

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

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adhesive A			Device: Adhesive A
Adhesive B			Device: Adhesive B
Adhesive C			Device: Adhesive C

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adhesive A	Device	Applied per manufacturer's instructions.	Adhesive A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retention of the restoration.		6, 12, 24, 36 months post-placement

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must be at least 19 years of age
Must have at least 3 qualifying noncarious Class V lesions of appropriate depth
Must be willing to sign consent form
Must be willing and able to return to UAB clinic for 4 study appointments
Must be in good medical health and able to tolerate dental procedures

Exclusion Criteria:

Current participation in other restorative product studies
Severe salivary gland dysfunction
Rampant caries (cavities)
Chronic periodontitis (gum disease)
Known allergies to the study materials
Unacceptable level of oral hygiene
Inability or unwillingness to attend study appointments

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Class V cavities

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John O Burgess, MS, DDS	University of Alabama at Birmingham (UAB) School of Dentistry	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham (UAB) School of Dentistry		Birmingham	Alabama	35294	United States

Condition Browse Module

MeSH Terms

ID	Term
D003731	Dental Caries

Ancestor Terms

ID	Term
D017001	Tooth Demineralization
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided