Clinical Evaluation of a Universal Adhesive in Noncarious Cervical Lesions

NCT ID: NCT02172664

Last Updated: 2019-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2018-05-31

Brief Summary

The purpose of this prospective clinical trial will be to evaluate the efficacy of an FDA approved and marketed universal dental adhesive formulation in adult noncarious cervical lesions using self-etch and selective etch approaches.

The hypothesis is that using a selective enamel etch with this universal adhesive will enhance the restoration margin performance.

Detailed Description

The purpose of this prospective clinical trial will be to evaluate the efficacy of a newly formulated universal dental adhesive formulation in adult noncarious cervical lesions using self-etch and selective etch approaches.

Thirty-three patients with at least two non-carious cervical lesions will receive one restoration utilizing the self-etch universal adhesive with no separate enamel etching and another restoration utilizing the universal adhesive and a a selective etch protocol in which in which enamel is etched with 37% phosphoric acid.

After a screening/baseline visit at which the restorative procedures listed above will conducted, the patient will be seen at recall visits after approximately 6, 12 and 24 months to observe sensitivity, retention, marginal discoloration and marginal adaptation.

Conditions

Cervical Lesions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Adhese Universal with self etch enamel etching

patients will receive one restoration on randomly selected study tooth utilizing the self-etch universal adhesive (Adhese Universal, Ivoclar Vivadent) with no separate enamel etching

Group Type: ACTIVE_COMPARATOR

Self etch enamel etching

Intervention Type: PROCEDURE

The adhesive will be applied according to manufacturer's instructions. If the lesion is greater than 2 mm in any dimension, incremental placement of Tetric EvoCeram composite (Ivoclar Vivadent) will occur with the first increment being placed against enamel.

selective etch protocol

Intervention Type: PROCEDURE

Total Etch (37% phosphoric acid; Ivoclar) will be placed on the enamel margin with no intentional placement on the dentin within the lesion. The adhesive will then be applied as instructed by the manufacturer. Tetric EvoCeram composite will be placed, light-cured, finished, and polished in the same manner as for the self-etch group.

Adhese Universal

Intervention Type: DEVICE

the universal adhesive, Adhese Universal , will be applied to the selected tooth following manufacturer instructions

selective etch protocol followed by Adhese Universal

patients will receive one restoration on randomly selected study tooth utilizing a 37% phosphoric acid solution followed by application of self-etch universal adhesive (Adhese Universal, Ivoclar Vivadent)

Group Type: EXPERIMENTAL

Self etch enamel etching

Intervention Type: PROCEDURE

The adhesive will be applied according to manufacturer's instructions. If the lesion is greater than 2 mm in any dimension, incremental placement of Tetric EvoCeram composite (Ivoclar Vivadent) will occur with the first increment being placed against enamel.

selective etch protocol

Intervention Type: PROCEDURE

Total Etch (37% phosphoric acid; Ivoclar) will be placed on the enamel margin with no intentional placement on the dentin within the lesion. The adhesive will then be applied as instructed by the manufacturer. Tetric EvoCeram composite will be placed, light-cured, finished, and polished in the same manner as for the self-etch group.

Adhese Universal

Intervention Type: DEVICE

the universal adhesive, Adhese Universal , will be applied to the selected tooth following manufacturer instructions

Interventions

Self etch enamel etching

The adhesive will be applied according to manufacturer's instructions. If the lesion is greater than 2 mm in any dimension, incremental placement of Tetric EvoCeram composite (Ivoclar Vivadent) will occur with the first increment being placed against enamel.

Intervention Type: PROCEDURE

selective etch protocol

Total Etch (37% phosphoric acid; Ivoclar) will be placed on the enamel margin with no intentional placement on the dentin within the lesion. The adhesive will then be applied as instructed by the manufacturer. Tetric EvoCeram composite will be placed, light-cured, finished, and polished in the same manner as for the self-etch group.

Intervention Type: PROCEDURE

Adhese Universal

the universal adhesive, Adhese Universal , will be applied to the selected tooth following manufacturer instructions

Intervention Type: DEVICE

Other Intervention Names

Adhese Universal; Ivoclar Vivadent

Eligibility Criteria

Inclusion Criteria

1. Willing to provide written consent and authorization for participation.

2. Be between 20 and 75 years of age at the time of recruitment

3. Have at least two non-carious cervical lesions present in canine or premolar teeth;

4. Anticipates availability for recalls (roughly 6 month, 12 month, and 24 month) through the two-year study period

5. The lesions selected will be at least 1 mm in depth (measured with a perio probe) and contain both enamel and dentin margins.

Exclusion Criteria

1. Severe medical complications (organ transplants, cancer, immunocompromised, long term antibiotic or steroid therapy);

2. Active caries on study teeth;

3. Bleeding on probing of study teeth;

4. Generalized severe periodontitis;

5. Patient reported symptoms (burning mouth, loss or diminished taste, saliva amount too little, needs liquids to eat dry foods) or clinical signs (erythematous tongue, chelitis, lack of pooled saliva) associated with dry mouth;

6. Patients determined to be at a high risk of caries as determined by a Caries Risk Assessment

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ivoclar Vivadent AG

INDUSTRY

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey A. Platt

Associate Professor of Dental Materials

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey A Platt, DDS

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University School of Dentistry

Indianapolis, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IVOC2014

Identifier Type: -

Identifier Source: org_study_id