Clinical Evaluation of a Universal Adhesive in Noncarious Cervical Lesions

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Evaluation of a Universal Adhesive in Noncarious Cervical Lesions

Conditions
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Cervical Lesions

Intervention / Treatment
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* Procedure: Self etch enamel etching
* Procedure: selective etch protocol
* Device: Adhese Universal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.1. Inclusion criteria Willing to provide written consent and authorization for participation. Be between 20 and 75 years of age at the time of recruitment Have at least two non-carious cervical lesions present in canine or premolar teeth; Anticipates availability for recalls (roughly 6 month, 12 month, and 24 month) through the two-year study period 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 Severe medical complications (organ transplants, cancer, immunocompromised, long term antibiotic or steroid therapy); Active caries on study teeth; Bleeding on probing of study teeth; Generalized severe periodontitis; 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; Patients determined to be at a high risk of caries as determined by a Caries Risk Assessment

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adhese Universal with self etch enamel etching<br>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 | Procedure: Self etch enamel etching<br>* 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.<br>* Other names: Ivoclar Vivadent;Procedure: selective etch protocol<br>* 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.<br>Device: Adhese Universal<br>* the universal adhesive, Adhese Universal , will be applied to the selected tooth following manufacturer instructions<br>|
| Experimental: selective etch protocol followed by Adhese Universal<br>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) | Procedure: Self etch enamel etching<br>* 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.<br>* Other names: Ivoclar Vivadent;Procedure: selective etch protocol<br>* 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.<br>Device: Adhese Universal<br>* the universal adhesive, Adhese Universal , will be applied to the selected tooth following manufacturer instructions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention of Restorations | The primary outcome measure will be restoration retention. In these non-retentive dental lesions, the adhesive will be the only mode of retention. Failure of the adhesive would result in loss of the restoration. | 6, 12, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Restoration Margins Marked as Stained or Discolored | The secondary outcome measure was the presence of discoloration of restoration margins as determined by blinded evaluators. | 6, 12, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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noncarious cervical lesions, dental adhesive, retention, enamel margin discoloration, self etch, selective etch procedures