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

Dentsply

Status: Completed

Conditions: Dental Caries

Treatments: Device: Experimental adhesive w/out phosphoric acid in post. rest.; Device: Experimental adhesive with phosphoric acid in post. rest.

Study type: Interventional

Funder types: Industry

Identifiers

NCT02071953

765-550

815642 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 37 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

Adhesive without acid pretreatment

Experimental group

Description:

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

Treatment:

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

Adhesive with acid pretreatment

Active Comparator group

Description:

Experimental adhesive with phosphoric acid in post. rest.

Treatment:

Device: Experimental adhesive with phosphoric acid in post. rest.