Clinical Evaluation of a Universal Adhesive in Noncarious Cervical Lesions

Cervical Lesions Clinical Trial

Official title:

Clinical Evaluation of a Universal Adhesive in Noncarious Cervical Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02172664
• Other study ID #: IVOC2014
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: May 2018

Study information

• Verified date: May 2019
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Lesions
• Uterine Cervical Diseases

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Indiana University School of Dentistry	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Ivoclar Vivadent AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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