Clinical Evaluation of a Universal Adhesive in Noncarious Cervical Lesions

Not Applicable

Completed

• Conditions: Cervical Lesions
• Interventions: Procedure: Self etch enamel etching; Procedure: selective etch protocol; Device: Adhese Universal

• Registration Number: NCT02172664
• Lead Sponsor: Indiana University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-16
• Study First Submitted QC: 2014-06-20
• Study First Posted: 2014-06-24
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2019-05
• Results First Submitted: 2019-05-23
• Results First Submitted QC: 2019-05-23
• Last Update Submitted: 2019-05-23
• Results First Posted: 2019-05-28
• Last Update Posted: 2019-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
selective etch protocol followed by Adhese Universal	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)
Adhese Universal with self etch enamel etching	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
Adhese Universal with self etch enamel etching	selective etch protocol	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
Adhese Universal with self etch enamel etching	Adhese Universal	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
selective etch protocol followed by Adhese Universal	Self etch enamel etching	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)
selective etch protocol followed by Adhese Universal	selective etch protocol	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)

Primary Outcome Measures

Name	Time	Method
Retention of Restorations	6, 12, 24 months	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.

Secondary Outcome Measures

Name	Time	Method
Number of Restoration Margins Marked as Stained or Discolored	6, 12, 24 months	The secondary outcome measure was the presence of discoloration of restoration margins as determined by blinded evaluators.

Trial Locations

Locations (1)

Indiana University School of Dentistry; 🇺🇸 Indianapolis, Indiana, United States