Clinical Evaluation of 3M™ ESPE™ Adper™ Scotchbond™ SE Self-Etch Adhesive in Class I and Class II Restorations in Adults

NCT ID: NCT00658138

Last Updated: 2024-10-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-12-31

Brief Summary

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The purpose of this study is to evaluate the performance of a new dental adhesive system in the restoration of Class I and Class II cavities in adult teeth.

Detailed Description

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Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Adhesive A

Group Type EXPERIMENTAL

3M ESPE Adper Scotchbond SE

Intervention Type DEVICE

To be used per manufacturer's instructions.

Adhesive B

Group Type ACTIVE_COMPARATOR

3M ESPE Adper Scotchbond 1XT

Intervention Type DEVICE

To be used per manufacturer's instructions.

Interventions

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3M ESPE Adper Scotchbond SE

To be used per manufacturer's instructions.

Intervention Type DEVICE

3M ESPE Adper Scotchbond 1XT

To be used per manufacturer's instructions.

Intervention Type DEVICE

Other Intervention Names

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Dental adhesive used for bonding fillings Dental adhesive used for bonding fillings

Eligibility Criteria

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Inclusion Criteria

* Must be at least 18 years of age
* Must have 2 or 4 qualifying Class I or Class II cavities
* Must be willing to sign consent form
* Must be willing to return to University dental 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
* Known allergies to dental products
* Unacceptable level of oral hygiene
* Chronic periodontitis (gum disease)
* Rampant caries (cavities)
* Severe salivary gland problems
* Inability or unwillingness to attend study appointments
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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3M

INDUSTRY

Sponsor Role collaborator

Solventum US LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giovanni Dondi dall'Orologio, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Bologna

Locations

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University of Bologna, Clinica Odontoiatrica

Bologna, , Italy

Site Status

Countries

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Italy

Other Identifiers

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CR-07-020

Identifier Type: -

Identifier Source: org_study_id

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