Prospective, Split-mouth, Comparative Study to Compare Clinical Outcomes of Two Different Posterior Composite

Ivoclar Vivadent

Status

Completed

Conditions

Defective Tooth Restorations

Caries

Treatments

Device: Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill)

Device: Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow)

Study type

Interventional

Funder types

Industry

Identifiers

NCT04708223

LL3274680

Details and patient eligibility

About

The objective of this 2-year split mouth comparative study, a randomized controlled study, is to determine whether the simplified placement procedure of the ultra-rapid polymerizing Tetric PowerFlow/ Tetric PowerFill with a reduced light polymerization time (3 s), yields the same clin-ical results as widely used commercially available dental composites (Tetric EvoCeram Bulk Fill, Tetric EvoFlow Bulk Fill) requiring up to 40 seconds of light polymerization time.

Full description

Patients, requiring posterior tooth restorations Class I and II or requesting amalgam restoration replacement, were treated in the clinical investigation. Each patient received two composite restorations in the posterior region.

Enrollment

51 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Each subject must need at least 2 restorations in a vital posterior tooth (in different quadrants)
Restorations may be indicated for caries removal and restoration, replacement of defec-tive restorations (i.e. fractured, stained, unaesthetic), or requested replacement of un-aesthetic restorations.
Must have given written consent to participate in the trial
Must be available for the required follow-up visits over 2 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
One, two or three surfaces per restoration
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 with evidence of bilateral posterior tooth contacts
Teeth that require one or no cuspal build-ups
Vital tooth
Preoperative sensibility on the teeth to be treated at maximum 3 on visual analog scale (10 = maximum)
Patient wishes to be treated in this clinical trial after oral information by the operator and after signing the informed patient form

Exclusion criteria

Allergies to ingredients of the materials under investigation (monomers)
Do not meet all inclusion criteria above
Have medical complications (organ transplants, long term antibiotic or steroid treatment, cancer or are immunocompromised) or disabilities rendering them unable to tolerate the time required to complete the restorations or to provide adequate oral hygiene
Suffer from xerostomia either by taking medications known to produce xerostomia or those with radiation induced xerostomia or Sjogren's syndrome subjects
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
Patients reporting having severe grinding/bruxing or clenching or in need of TMJ-related therapy
Have tooth with exposed pulp during preparation or caries removal or require indirect pulp capping
Inclusion of teeth that are non-vital or that exhibit signs of pulpal pathology (pulpitis)
If the working field cannot be maintained in a dry state for treatment