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

Caries Clinical Trial

Official title:

A 24-Month Clinical Evaluation of an Ultra-rapid Polymerizing Resin Composite

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04708223
• Other study ID #: LL3274680
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: January 30, 2023

Study information

• Verified date: April 2022
• Source: Ivoclar Vivadent AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 51
• Est. completion date: January 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Caries
• Defective Tooth Restorations

Intervention

Device:
• Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow)
Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s.
• Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill)
Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill (control group) were conventionally cured for 10 s per increment.

Locations

Country	Name	City	State
United States	University of Illinois College of Dentistry	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ivoclar Vivadent AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post-operative tooth sensitivity	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"	Baseline to 36 months
Secondary	restoration quality evaluation	assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"	Baseline to 36 months