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OpenTrials
Completed

NCT Number: NCT01369108

Clinical Study on a New Flowable Composite as a Restorative 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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham School of Dentistry, 605 School of Dentistry Building, 1919 7th Avenue South

Birmingham, Alabama, 35233-2005, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flowable composite

Device

Restoration of small Class V and I cavities in molar and premolar teeth

Other names: Filtek Supreme Ultra Flowable Restorative 3M ESPE)

Conventional composite restorative

Device

Restoration of small Class V and I cavities in molar and premolar teeth

Primary outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

Solventum US LLC

Industry

Collaborators

  • 3M

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 8, 2011
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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