N/A
N=70
Comparative Study of Experimental Dental Adhesive With and Without Phosphoric Acid Pretreatment
Dental Caries
Bottom Line
View on ClinicalTrials.gov: NCT02071953 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: Color Match — 53; 54; 50; 52 teeth
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Experimental adhesive w/out phosphoric acid in post. rest. (Device); Experimental adhesive with phosphoric acid in post. rest. (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Dentsply International
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Color Match |
53; 54; 50; 52; 30; 34 | — |
| PRIMARY Marginal Discoloration |
53; 54; 50; 52; 27; 34 | — |
| PRIMARY Marginal Integrity |
53; 53; 49; 52; 26; 34 | — |
| PRIMARY Presence of Secondary Dental Caries (Cavities) |
53; 54; 50; 52; 30; 34 | — |
| PRIMARY Presence of Restoration Fractures (Localized or Bulk) |
52; 53; 47; 52; 27; 34 | — |
| PRIMARY Post-operative Sensitivity |
51; 53; 50; 52; 30; 34 | — |
| PRIMARY Surface Condition of Restoration |
53; 54; 47; 52; 29; 34 | — |
| PRIMARY Gingival Inflammation Index |
12; 9; 9; 11; 1; 0 | — |
Summary
The intent of this study is to evaluate the clinical performance of an experimental dental bonding agent for use with dental restorative composites with and without pretreatment of the tooth dentin and enamel using phosphoric acid etching.
Eligibility Criteria
Inclusion Criteria
- Patients in need of Class I and Class II restorations in premolars and molars.
Exclusion Criteria
- Patients with fewer than 20 teeth
- Patients exhibiting poor oral hygiene or uncontrolled periodontal disease
- Pregnant women or lactating mothers
- Patients with known allergies to HEMA or resin-based materials
- Patients with medical conditions that would contraindicate dental treatment
- Patients with xerostomia
Data sourced from ClinicalTrials.gov (NCT02071953). 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.