Clinical trial NCT04686422: Clinical Evaluation of a Bulk Fill Resin Composite
Official title: Clinical Evaluation of a Bulk Fill Resin Composite
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Unsatisfactory or Defective Restoration of Tooth
Lead sponsor: Ivoclar Vivadent AG
Sponsor class: INDUSTRY
First posted: 2020-12-28
Enrollment: 39
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: FDI 11 - Postoperative Hypersensitivity
timeFrame: Baseline
measure: Pulp Integrity
timeFrame: Baseline
measure: Overall Survival Rate
timeFrame: Baseline
measure: FDI 11 - Postoperative Hypersensitivity
timeFrame: 6 Month
measure: Pulp Integrity
timeFrame: 6 Month
measure: Overall Survival Rate
timeFrame: 6 Month
measure: FDI 11 - Postoperative Hypersensitivity
timeFrame: 12 Month
measure: Pulp Integrity
timeFrame: 12 Month
measure: Overall Survival Rate
timeFrame: 12 Month
measure: FDI 11 - Postoperative Hypersensitivity
timeFrame: 24 Month
measure: Pulp Integrity
timeFrame: 24 Month
measure: Overall Survival Rate
timeFrame: 24 Month
measure: FDI 11 - Postoperative Hypersensitivity
timeFrame: 36 Month
measure: Pulp Integrity
timeFrame: 36 Month
measure: Overall Survival Rate
timeFrame: 36 Month
Secondary outcomes:
measure: FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
timeFrame: Baseline
measure: FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
timeFrame: 6 Month
measure: FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
timeFrame: 12 Month
measure: FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
timeFrame: 24 Month
measure: FDI Criteria (Surface Lustre, Surface Staining, Colour Match, Material Fracture, Occlusal Wear, Tooth Integrity)
timeFrame: 36 Month
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB School of Dentistry
state: Alabama
Study officials:
affiliation: UAB School of Dentistry
name: Nathaniel Lawson, Dr
role: PRINCIPAL_INVESTIGATOR
References: