Clinical Evaluation of a Universal Adhesive in Noncarious Cervical Lesions

Indiana University

Status: Completed

Conditions: Cervical Lesions

Treatments: Procedure: selective etch protocol; Procedure: Self etch enamel etching; Device: Adhese Universal

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02172664

IVOC2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 1.1. 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:

1.2. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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33 participants in 2 patient groups

Adhese Universal with self etch enamel etching

Active Comparator group

Description:

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

Treatment:

Procedure: selective etch protocol

Procedure: Self etch enamel etching

Device: Adhese Universal

selective etch protocol followed by Adhese Universal

Experimental group

Description:

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)

Treatment:

Procedure: selective etch protocol

Procedure: Self etch enamel etching

Device: Adhese Universal