Clinical trial NCT02071953: Comparative Study of Experimental Dental Adhesive With and Without Phosphoric Acid Pretreatment
Official title: Clinical Evaluation of an Experimental Universal Adhesive Used With and Without Phosphoric Acid Pretreatment in Posterior Composite Resin Restorations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Lead sponsor: Dentsply Sirona Inc.
Sponsor class: INDUSTRY
First posted: 2014-02-26
Enrollment: 37
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The intent of this study is to evaluate the clinical performance of an experimental dental bonding agent (adhesive) 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

Primary outcomes:
measure: Color Match
timeFrame: Baseline, 6 months, 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.
measure: Marginal Discoloration
timeFrame: Baseline, 6 months, 18 months. Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.
measure: Marginal Integrity
timeFrame: Baseline, 6 months, 18 months. Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.
measure: Presence of Secondary Dental Caries (Cavities)
timeFrame: Baseline, 6 months, 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.
measure: Presence of Restoration Fractures (Localized or Bulk)
timeFrame: Baseline, 6 months, 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.
measure: Post-operative Sensitivity
timeFrame: Baseline, 6 months, 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.
measure: Surface Condition of Restoration
timeFrame: Baseline, 6 months, 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.
measure: Gingival Inflammation Index
timeFrame: 18 months; Note: The 36 month evaluation was an option in the protocol at the time of investigation initiation. The study was concluded at 18 months. Thus 36 month data does not exist.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Pennsylvania
name: Ricardo Walter, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Academy House of Professional Offices
name: Alan M. Atlas, DMD
role: PRINCIPAL_INVESTIGATOR
References: