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Completed

NCT Number: NCT02172664

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.

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Key information

Conditions

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University School of Dentistry

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self etch enamel etching

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.

Other names: Adhese Universal, Ivoclar Vivadent

selective etch protocol

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

Device

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

Primary outcomes

  1. Retention of Restorations

    Time frame: 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 outcomes

  1. Number of Restoration Margins Marked as Stained or Discolored

    Time frame: 6, 12, 24 months

    The secondary outcome measure was the presence of discoloration of restoration margins as determined by blinded evaluators.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Ivoclar Vivadent AG

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jun 24, 2014
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.