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Completed

NCT Number: NCT04686422

Clinical Evaluation of a Bulk Fill Resin Composite

The purpose of this clinical trial is to measure the clinical outcomes of Tetric PowerFill Class I and II restorations cured in 3 seconds with the Bluephase PowerCure curing unit.

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Key information

Age range

19 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAB School of Dentistry

Birmingham, Alabama, 35294-0007, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Each subject must need at least 1 restoration in a vital posterior tooth
  • Must have given written consent to participate in the trial
  • Replacement of defective restorations (i.e. fractured, stained, unaesthetic) with or with-out caries are acceptable
  • Must be available for the required follow-up visits over 3 years
  • Restored teeth must have occlusal contact with opposing teeth or restored teeth
  • Restoration width should be equal to or greater than 1/3 the distance from buccal to lin-gual cusp tips
  • 75% of the restorations Class II (minimum) and 25% Class I
  • Each Class II will have at least one proximal contact
  • 75% in molars (minimum) and 25% in premolars
  • All restored teeth must have at least one occlusal contact in habitual closure
  • Must have 20 or more teeth

Exclusion criteria

  • If they have an allergy to ingredients of the materials under investigation (monomers)
  • Do not meet all inclusion criteria above
  • Have severe medical complications (organ transplants, long term antibiotic or steroid treatment, cancer or are immunocompromised) or disabilities meaning they 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 xerostomia or Sjogren's syndrome - as dry mouth increases tooth and restoration wear as well as the development of caries.
  • Have teeth with advanced or severe periodontitis, rampant caries or poor oral hygiene which may require extraction of the teeth to be restored
  • Present with any systemic or local disorders that contraindicate the dental procedures included in this study
  • Have unstable occlusion
  • Have severe grinding/bruxing or clenching or need TMJ-related therapy
  • Have tooth with exposed pulp during preparation or caries removal
  • Teeth that are non-vital or that exhibit signs of pulpal pathology for restoration
  • Teeth that require cuspal build-ups involving more than one cusp

Treatment and study plan

Tetric PowerFill

Device

Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.

Primary outcomes

  1. FDI 11 - Postoperative Hypersensitivity

    Time frame: Baseline

    assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

  2. Pulp Integrity

    Time frame: Baseline

    Restored teeth are assessed by a cold air stimuli test (air syringe) by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable")

  3. Overall Survival Rate

    Time frame: Baseline

    Restorations were examined by a dentist

  4. FDI 11 - Postoperative Hypersensitivity

    Time frame: 6 Month

    assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

  5. Pulp Integrity

    Time frame: 6 Month

    Restored teeth are assessed by a cold air stimuli test (air syringe) by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable")

  6. Overall Survival Rate

    Time frame: 6 Month

    Restorations were examined by a dentist

  7. FDI 11 - Postoperative Hypersensitivity

    Time frame: 12 Month

    assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

  8. Pulp Integrity

    Time frame: 12 Month

    Restored teeth are assessed by a cold air stimuli test (air syringe) by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable")

  9. Overall Survival Rate

    Time frame: 12 Month

    Restorations were examined by a dentist

  10. FDI 11 - Postoperative Hypersensitivity

    Time frame: 24 Month

    assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

  11. Pulp Integrity

    Time frame: 24 Month

    Restored teeth are assessed by a cold air stimuli test (air syringe) by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable")

  12. Overall Survival Rate

    Time frame: 24 Month

    Restorations were examined by a dentist

  13. FDI 11 - Postoperative Hypersensitivity

    Time frame: 36 Month

    assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable") following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

  14. Pulp Integrity

    Time frame: 36 Month

    Restored teeth are assessed by a cold air stimuli test (air syringe) by VAS (Visual Analog Scale, 0 "No pain at all" - 10 "The worst pain imaginable")

  15. Overall Survival Rate

    Time frame: 36 Month

    Restorations were examined by a dentist

Secondary outcomes

  1. FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)

    Time frame: Baseline

    assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

  2. FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)

    Time frame: 6 Month

    assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

  3. FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)

    Time frame: 12 Month

    assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

  4. FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)

    Time frame: 24 Month

    assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

  5. FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)

    Time frame: 36 Month

    assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

Sponsors and collaborators

Lead sponsor

Ivoclar Vivadent AG

Industry

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Dec 28, 2020
Registry last updated
Oct 23, 2025

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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