Comparative Study of Experimental Dental Adhesive With and Without Phosphoric Acid Pretreatment

NCT ID: NCT02071953

Last Updated: 2022-11-28

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

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-09-30

Brief Summary

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The intent of this study is to evaluate the clinical performance of an experimental dental bonding agent for use with dental restorative composites with and without pretreatment of the tooth dentin and enamel using phosphoric acid etching.

Detailed Description

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The intent of this study is to evaluate the clinical performance of an experimental dental bonding agent (adhesive) for use with dental restorative composites with and without pretreatment of the tooth dentin and enamel using phosphoric acid etching.

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

NONE

Study Groups

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Adhesive without acid pretreatment

Experimental adhesive w/out phosphoric acid in post. rest.

Group Type EXPERIMENTAL

Experimental adhesive w/out phosphoric acid in post. rest.

Intervention Type DEVICE

Experimental adhesive without phosphoric acid in posterior restorations

Adhesive with acid pretreatment

Experimental adhesive with phosphoric acid in post. rest.

Group Type ACTIVE_COMPARATOR

Experimental adhesive with phosphoric acid in post. rest.

Intervention Type DEVICE

Experimental adhesive with phosphoric acid in posterior restorations

Interventions

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Experimental adhesive w/out phosphoric acid in post. rest.

Experimental adhesive without phosphoric acid in posterior restorations

Intervention Type DEVICE

Experimental adhesive with phosphoric acid in post. rest.

Experimental adhesive with phosphoric acid in posterior restorations

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients in need of Class I and Class II restorations in premolars and molars.

Exclusion Criteria

* Patients with fewer than 20 teeth
* Patients exhibiting poor oral hygiene or uncontrolled periodontal disease
* Pregnant women or lactating mothers
* Patients with known allergies to HEMA or resin-based materials
* Patients with medical conditions that would contraindicate dental treatment
* Patients with xerostomia
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dentsply International

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ricardo Walter, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Alan M. Atlas, DMD

Role: PRINCIPAL_INVESTIGATOR

Academy House of Professional Offices

Other Identifiers

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815642

Identifier Type: OTHER

Identifier Source: secondary_id

765-550

Identifier Type: -

Identifier Source: org_study_id

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