Clinical Study on a New Flowable Composite as a Restorative in Adult Teeth

September 30, 2024 updated by: Solventum US LLC

Clinical Evaluation of a Low Shrinkage Flowable Resin Composite in Adult Teeth

Study hypothesis: a new, low polymerization stress flowable composite performs no differently to a conventional, highly filled composite filling material when used as a restorative in small cavities in back teeth.

Study will evaluate the clinical performance of a low shrinking flowable composite filling material, compared with a conventional, highly filled composite restorative when used to permanently fill small cavities in molar and premolar teeth in adult patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will evaluate clinical performance of a low shrink flowable composite filling material and compare it with a conventional, highly filled composite. The study materials will be used to restore small cavities in molar and premolar teeth in adult patients.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233-2005
        • University of Alabama at Birmingham School of Dentistry, 605 School of Dentistry Building, 1919 7th Avenue South

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 19 years or older
  • must give written consent
  • be in good general health
  • be available for required follow-up visits
  • have at least 28 teeth

Exclusion Criteria:

  • has rampant, uncontrolled caries
  • has advanced, untreated periodontal disease
  • heavy use of smoking tobacco (2 packs or equivalent a day)or chewing tobacco
  • has systemic or local disorders that contra-indicate the dental procedures needed in this study
  • has evidence of xerostomia
  • has evidence of severe bruxing or clenching, or in need of Temporomandibular Joint (TMJ) related therapy
  • is pregnant at time of screening or tooth restoration
  • has known sensitivity to acrylates or related materials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Flowable composite
Device: Flowable composite
Restoration of small Class V and I cavities in molar and premolar teeth
Other Names:
  • Filtek Supreme Ultra Flowable Restorative 3M ESPE)
Active Comparator: Conventional composite
Highly filled conventional composite restorative
Device: Conventional composite restorative
Restoration of small Class V and I cavities in molar and premolar teeth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Performance by Cvar & Ryge Scores
Time Frame: baseline, 6, 12 and 24 months

Clinical performance reported on 6 parameters as the % of teeth with perfect scores ("A" rating).

Cvar & Ryge scores measure 6 parameters: Anatomic form (rated A,B= satisfactory, C=unsatisfactory); Color Match (A=match, B=mismatch, but within normal, C=mismatch outside normal); Marginal Adaptation (A=no visible crevice, B=no exposure of dentin, C=defect to enamel-dentine junction, D= fracture, missing); Marginal Discoloration (A=none, B= marginal discoloration, C=marginal discoloration to pulpal direction); Surface Integrity (A=smooth, B=slight rough, C=Pitted, D=fracture)'Secondary caries (A=none, D=present).
baseline, 6, 12 and 24 months
Clinical Performance by VAS (Pain Scale)
Time Frame: baseline, 6, 12 and 24 months
Sensitivity to cold was measured by applying a cotton pellet soaked with pulp vitality refrigerant spray (Endo Ice, Coltene/ Whaledent, Cuyahoga Falls, OH, USA) to the tooth for three seconds. Sensitivity to biting was measured by having the patient bite on a cotton roll for five seconds. After each test, the subject was asked to place an ''X'' on a 10-mm line labeled ''1'' on the left and ''10'' on the right. Patients were told that a ''10'' represents the worst pain they can imagine (ie, childbirth, major surgery, or kidney stone) and that ''1'' represents no sensation at all.
baseline, 6, 12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solventum US LLC

Collaborators

3M

Investigators

  • Principal Investigator: John O Burgess, DDS, MS, Unversity of Alabama at Birmingam Dental School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

June 7, 2011

First Submitted That Met QC Criteria

June 7, 2011

First Posted (Estimated)

June 8, 2011

Study Record Updates

Last Update Posted (Actual)

October 2, 2024

Last Update Submitted That Met QC Criteria

September 30, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-10-013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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