Clinical trial NCT04708223: Prospective, Split-mouth, Comparative Study to Compare Clinical Outcomes of Two Different Posterior Composite
Official title: A 24-Month Clinical Evaluation of an Ultra-rapid Polymerizing Resin Composite
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries
Defective Tooth Restorations
Lead sponsor: Ivoclar Vivadent AG
Sponsor class: INDUSTRY
First posted: 2021-01-13
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split-mouth Design
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity
timeFrame: Baseline
measure: Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity
timeFrame: 6 Month
measure: Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity
timeFrame: 12 Month
measure: Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity
timeFrame: 24 Month
measure: Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity
timeFrame: 36 Month
Secondary outcomes:
measure: Restoration Quality Evaluation
timeFrame: Baseline
measure: Restoration Quality Evaluation
timeFrame: 6 Month
measure: Restoration Quality Evaluation
timeFrame: 12 Month
measure: Restoration Quality Evaluation
timeFrame: 24 Month
measure: Restoration Quality Evaluation
timeFrame: 36 Month
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois College of Dentistry
state: Illinois
Study officials:
affiliation: University of Illinois College of Dentistry
name: Lyndon F. Cooper, Dr.
role: PRINCIPAL_INVESTIGATOR
References: