Evaluate the Effectiveness of an Experimental Urethane Dimethacrylate Resin Based Dental Composite Material

NCT ID: NCT02018822

Last Updated: 2018-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2017-09-30

Brief Summary

This double blind randomized controlled prospective clinical trial will compare the clinical success of two tooth colored resin composite dental filling materials - TPH3 (Dentsply Caulk) and an experimental urethane dimethacrylate resin based composite resin (Dentsply Caulk) for wear resistance, staining and marginal seal using modified Ryge criteria to evaluate the posterior restorations for 24 months in duration

Detailed Description

The purposes of this clinical trial is to evaluate two composite resins used to restore Class I and Class II cavities in teeth of adults. The clinical study will evaluate the resin composite restorations placed in Class I and Class II cavity preparations for anatomic form, color match, marginal integrity, marginal discoloration, proximal contact, polishability, caries, sensitivity, gingival index, staining,wear, and thermal response for 24 months..

Conditions

Dental Caries; Restorative Material

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

All Participants

Participants who needed at least two tooth restorations

Group Type: EXPERIMENTAL

urethane dimethacrylate

Intervention Type: DEVICE

Experimental urethane dimethacrylate resin based composite resin for teeth used with prime and Bond Elect bonding agent

TPH3

Intervention Type: DEVICE

light-cured resin composite for teeth

Esthet-X HD

Intervention Type: DEVICE

light cured resin composite for teeth made by Dentsply Caulk

Interventions

urethane dimethacrylate

Experimental urethane dimethacrylate resin based composite resin for teeth used with prime and Bond Elect bonding agent

Intervention Type: DEVICE

TPH3

light-cured resin composite for teeth

Intervention Type: DEVICE

Esthet-X HD

light cured resin composite for teeth made by Dentsply Caulk

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• must be in need of at least two restorations in natural tooth
• replacement restorations with or without caries are acceptable
• must be available for the required post-operative follow-up visits
• restorations to be in bicuspids, 1st or 2nd molars
• restorations to be in contact with opposing natural or crowned teeth
• class II restorations must have at least one proximal contact
• restorations must have a buccal to lingual/palatal width equal to or greater than 1/3 the distance from buccal to lingual/palatal cusp tips
• 75% of the restorations must be Class II
• all restorations must have at least one occlusal contact in habitual closure

• present with any systemic or local disorders that contra-indicate the dental procedures included in this study
• have an unstable occlusion
• have severe bruxing or clenching or need of TMJ related therapy
• have teeth with periapical pathology or expected pulp exposures
• have teeth that are non-vital or that exhibit signs of pulpal pathology
• Pregnancy
• Known sensitivity to methacrylates and/or acrylates

Exclusion Criteria

• have severe medical complications (organ transplants, long term antibiotic or steroid treatment, cancer or immunocompromised) or disabilities who may not be able to tolerate the time required to complete the restorations or to provide adequate oral hygiene
• have xerostomia either by taking medications known to produce xerostomia or those with radiation induced or Sjogren's syndrome patients
• have chronic periodontitis, rampant caries or poor oral hygiene which may require extraction of the teeth to be restored
• have a history of chronic bruxism and those unavailable for long term recall
• can not tolerate the rubber dam required for tooth isolation during preparation and restoration.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Hans Malmstrom

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Rochester, Eastman Institute for Oral Health

Rochester, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

765-552

Identifier Type: -

Identifier Source: org_study_id