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NCT03764059

Clinical Study of Filtek™ Bulk Fill Posterior Restorative in Class I and II Restorations

Completed NA Results posted Last updated 21 July 2023
What this trial tests

NA trial testing Filtek™ Bulk Fill Posterior Restorative in Dental Caries Class I in 240 participants. Completed in 14 November 2019.

Timeline
17 October 2017
Primary endpoint
14 November 2019
14 November 2019

Quick facts

Lead sponsor3M
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment240
Start date17 October 2017
Primary completion14 November 2019
Estimated completion14 November 2019
Sites3 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

3M — full company profile →

Who can join

Adults 18 to 70, any sex, with Dental Caries Class I or Dental Caries Class II. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Clinical Acceptance Rate of Restoration at 1 Year After Replacement Primary · 1 Year after restoration

According to Clinical Trial Guideline for Polymer-based Dental Restorative Materials (YY/T 0990-2015), the clinically acceptable definition of restoration at 1 year after replacement was as follows: The retention and fracture score of restoration at 1 year after replacement was A; the marginal fracture, the appearance and the marginal adaptationof restoration was A or B.

GroupValue95% CI
Investigational Device/Experimental Group: Filtek™ Bulk Fill Posterior Restorative120
Control Device/Control Group: Filtek™ Z350XT Universal Restorative119
Investigational Device/Experimental Group: Filtek™ Bulk Fill Posterior Restorative0
Control Device/Control Group: Filtek™ Z350XT Universal Restorative1

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected from enrollment through study completion, an average of 1 year per participant.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Investigational Device/Experimental Group: Filtek™ Bulk Fill Posterior Restorative
Serious: 0/120 (0%)
Deaths: 0/120
Control Device/Control Group: Filtek™ Z350XT Universal Restorative
Serious: 0/120 (0%)
Deaths: 0/120
Other adverse events (53 terms — click to expand)

ReactionSystemInvestigational Device/Exp…Control Device/Control Gro…
Non-target cariesGastrointestinal disorders——
Upper respiratory infectionRespiratory, thoracic and mediastinal disorders——
Post-operative tooth sensitivityGastrointestinal disorders——
Impacted wisdom teethGastrointestinal disorders——
Wisdom tooth extractionGastrointestinal disorders——
Pericoronitis of non-target teethGastrointestinal disorders——
AcneSkin and subcutaneous tissue disorders——
Irregular dentitionGastrointestinal disorders——
Chronic periodontitisGastrointestinal disorders——
Sensitivity of non-target teeth after operationGastrointestinal disorders——
Wedge-shaped defect of non-target teethGastrointestinal disorders——
Mild redness and swelling of gingival margin of non-target teethGastrointestinal disorders——
PeriodontitisGastrointestinal disorders——
Tooth sensitivity during operationGastrointestinal disorders——
Kidney stoneRenal and urinary disorders——
PregnancyPregnancy, puerperium and perinatal conditions——
Chronic periapical periodontitisGastrointestinal disorders——
Plaque-induced gingivitisGastrointestinal disorders——
DiarrhoeaGastrointestinal disorders——
Gum bleeding on the target sideGastrointestinal disorders——
Gum pain on the target sideGastrointestinal disorders——
Mild redness and swelling of gingival margin on the target sideGastrointestinal disorders——
Pain of buccal mucosa of target teethGastrointestinal disorders——
Mucosal ulceration of target teethGastrointestinal disorders——
Radiolucent area of root tip of target teethGastrointestinal disorders——
Malaise of occlusion of target teethGastrointestinal disorders——
Spontaneous discomfort of target teethGastrointestinal disorders——
Edge caries of non-target teethGastrointestinal disorders——
Non-target residual rootGastrointestinal disorders——
Falling of filling material of non-target teethProduct Issues——
Secondary Caries of non-target teethGastrointestinal disorders——
Secondary Caries of non-target teeth (after endodontic treatment)Gastrointestinal disorders——
Reversible pulpitis of non-target teethGastrointestinal disorders——
Chronic pulpitis of non-target teethGastrointestinal disorders——
Acute attack of chronic pulpitis of non-target teethInfections and infestations——
Non-target caries, gingivitisGastrointestinal disorders——
Microdontia of non-target teethGastrointestinal disorders——
Pulpitis of non-target teethGastrointestinal disorders——
Dental defect of non-target teethGastrointestinal disorders——
Gingival ulcer of non-target teethGastrointestinal disorders——

Data from ClinicalTrials.gov NCT03764059 adverse events section.

Sponsor's own description

Purpose of the Study:This study was to evaluate the 1 week, 1 year safety and effectiveness of dental composite resin (Filtek™ Bulk Fill Posterior Restorative) in restoring Class I and II dental cavities in posterior teeth.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other 3M trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing