N/A
N=66
Clinical Evaluation of a Universal Adhesive in Noncarious Cervical Lesions
Cervical Lesions
Bottom Line
View on ClinicalTrials.gov: NCT02172664 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Retention of Restorations — 38; 38; 37; 37 Non-carious cervical lesions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Self etch enamel etching (Procedure); selective etch protocol (Procedure); Adhese Universal (Device)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Retention of Restorations |
38; 38; 37; 37; 34; 31 | — |
| SECONDARY Number of Restoration Margins Marked as Stained or Discolored |
1; 1; 0; 0; 5; 1 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02172664). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.