Clinical Evaluation of a Universal Adhesive in Noncarious Cervical Lesions

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.

Study Overview

• Status: Completed
• Conditions: Cervical Lesions
• Intervention / Treatment: Procedure: Self etch enamel etching; Procedure: selective etch protocol; Device: Adhese Universal

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Procedure: 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.; Other Names: Adhese Universal; Ivoclar Vivadent; 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.; Device: Adhese Universal; the universal adhesive, Adhese Universal , will be applied to the selected tooth following manufacturer instructions
Experimental: 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)	Procedure: 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.; Other Names: Adhese Universal; Ivoclar Vivadent; 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.; Device: Adhese Universal; the universal adhesive, Adhese Universal , will be applied to the selected tooth following manufacturer instructions

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Ivoclar Vivadent AG
• Investigators: Principal Investigator: Jeffrey A Platt, DDS, Indiana University

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: June 16, 2014
• First Submitted That Met QC Criteria: June 20, 2014
• First Posted (Estimate): June 24, 2014

Study Record Updates

• Last Update Posted (Actual): May 28, 2019
• Last Update Submitted That Met QC Criteria: May 23, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: retention; noncarious cervical lesions; dental adhesive; enamel margin discoloration; self etch; selective etch procedures
• Additional Relevant MeSH Terms: Uterine Diseases; Uterine Cervical Diseases
• Other Study ID Numbers: IVOC2014