Clinical Evaluation of a Universal Adhesive in Noncarious Cervical Lesions

NCT02172664 | Completed Results

• 1 other identifier: IVOC2014
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Lesions

Keywords

noncarious cervical lesions; dental adhesive; retention; enamel margin discoloration; self etch; selective etch procedures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Restoration Margins Marked as Stained or Discolored

  6, 12, 24 months

Study Arms (2)

Adhese Universal with self etch enamel etching

ACTIVE COMPARATOR

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; Procedure: selective etch protocol; Device: Adhese Universal

selective etch protocol followed by Adhese Universal

EXPERIMENTAL

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; Procedure: selective etch protocol; Device: Adhese Universal

Interventions

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.

Also known as: Adhese Universal, Ivoclar Vivadent

Adhese Universal with self etch enamel etching; selective etch protocol followed by Adhese Universal

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 with self etch enamel etching; selective etch protocol followed by Adhese Universal

Adhese Universal DEVICE

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

Adhese Universal with self etch enamel etching; selective etch protocol followed by Adhese Universal

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Ivoclar Vivadent AG: collaborator

Study Sites (1)

Indiana University School of Dentistry

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Interventions

Ivoclar Universal Cement

Results Point of Contact

• Title: Dr. Jeffrey Platt
• Organization: Indiana University School of Dentistry

jplatt2@iu.edu

3172747229

Study Officials

• Jeffrey A Platt, DDS

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Dental Materials

Study Record Dates

• First Submitted: June 16, 2014
• First Posted: June 24, 2014
• Study Start: June 1, 2014
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 28, 2019
• Results First Posted: May 28, 2019

Record last verified: 2019-05

Locations

US (1)