Clinical trial NCT02172664: Clinical Evaluation of a Universal Adhesive in Noncarious Cervical Lesions
Official title: Clinical Evaluation of a Universal Adhesive in Noncarious Cervical Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Lesions
Keywords: noncarious cervical lesions
dental adhesive
retention
enamel margin discoloration
self etch
selective etch procedures
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Ivoclar Vivadent AG
First posted: 2014-06-24
Enrollment: 33
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Retention of Restorations
timeFrame: 6, 12, 24 months
Secondary outcomes:
measure: Number of Restoration Margins Marked as Stained or Discolored
timeFrame: 6, 12, 24 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Dentistry
state: Indiana
Study officials:
affiliation: Indiana University
name: Jeffrey A Platt, DDS
role: PRINCIPAL_INVESTIGATOR
References: