NCT03764059

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 17, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2019

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

July 21, 2023

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

2.1 years

First QC Date

December 3, 2018

Results QC Date

May 22, 2023

Last Update Submit

July 13, 2023

Conditions

Dental Caries Class IDental Caries Class II

Keywords

dental restorativeComposite posterior restorative

Outcome Measures

Primary Outcomes (1)

  • Clinical Acceptance Rate of Restoration at 1 Year After Replacement

    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.

    1 Year after restoration

Study Arms (2)

Investigational device/experimental group: Filtek™ Bulk Fill Posterior Restorative

EXPERIMENTAL

The investigational device, Filtek™ Bulk Fill Posterior Restorative, was used for class 1 or 2 restorative in experimental group. The clinical assessments were performed immediately after restoration and included restoration retention/fracture, marginal fracture, anatomic form/marginal integrity, proximal contact, color match, surface texture/roughness, staining, marginal discoloration/secondary caries and pulp vitality. Subjects returned to the site for follow up visits at 1 week and 1 year postoperative for the same clinical assessments.

Device: Filtek™ Bulk Fill Posterior Restorative

Control device/control group: Filtek™ Z350XT Universal Restorative

ACTIVE COMPARATOR

The control device, Filtek™ Z350XT Universal Restorative, which was approved by CFDA in 2010 and has been in the market for 5 years with some validated clinical data, was used for class 1 or 2 restorative in control group. The clinical assessments were performed immediately after restoration and included restoration retention/fracture, marginal fracture, anatomic form/marginal integrity, proximal contact, color match, surface texture/roughness, staining, marginal discoloration/secondary caries and pulp vitality. Subjects returned to the site for follow up visits at 1 week and 1 year postoperative for the same clinical assessments.

Device: Filtek™ Z350XT Universal Restorative

Interventions

Filtek™ Bulk Fill Posterior RestorativeDEVICE

The subjects were assigned to either the investigational device (Filtek™ Bulk Fill Posterior Restorative) or the control device (Filtek™ Z350XT Universal Restorative) per web-based randomization system.

Investigational device/experimental group: Filtek™ Bulk Fill Posterior Restorative
Filtek™ Z350XT Universal RestorativeDEVICE

The subjects were assigned to either the investigational device (Filtek™ Bulk Fill Posterior Restorative) or the control device (Filtek™ Z350XT Universal Restorative) per web-based randomization system.

Also known as: Filtek™ Supreme Ultra Universal Restorative, Filtek™ Supreme XTE Universal Restorative, Filtek™ Ultimate Universal Restorative
Control device/control group: Filtek™ Z350XT Universal Restorative

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female,18 to 70 years old (including 18 and 70 years)
  • Good health, no significant systemic disease;
  • Normal opening degree;
  • Molar (preferred) or premolar teeth
  • Cavity type with belongs to any of the following： 1) Class I, including the failed class I restoration which require to be repaired.; 2) Class II, including premolar and molar except the second molar (the failed class II restoration which require to be repaired is also included), and the gingival wall of cavity is above the free gingival margin coronally; 3) Class II cavity on the second molar when the third molar exists, and the gingival wall of cavity is above the free gingival margin coronally; 4) Class II, MO or MOD cavity on the second molar when the third molar does not exist (the failed class II restoration which require to be repaired is also included), and the gingival wall of cavity is above the free gingival margin coronally;
  • Cavity size: the buccolingual diameter of cavity is no less than the 1/3 and of the buccolingual cusp distance;
  • Occlusion with natural teeth;
  • Cavity depth: no less than 1/2 of dentin with a normal pulp status;
  • Be able to understand informed consent and to provide written inform consent ;
  • Be in good compliance with the protocol and willing to return to the site for follow up visits .

You may not qualify if:

  • Allergy to multiple medicines; allergy to resin or other polymer material;
  • Acute caries, severe periodontitis, salivary glands malfunction, dysfunction/disorder of TMJ (temporomandibular joint);
  • Poor oral hygiene, DMTF:18-34y \>4, 35-70y \>5;
  • Teeth with abnormal staining ;
  • Pathological abrasion (e.g. bruxism, clenching), acid corrosion, cracked-teeth and other non-caries diseases.
  • Abnormal occlusion;
  • Severe systemic or mental disorders;
  • Pregnant or intended to be pregnant (pregnant test is positive ) or breast feeding women;
  • Cavity do not meet the criteria based on the investigator's judgement;
  • Resin Composite is not an appropriate restoration for the subject
  • Pulp exposure or bottom of cavity is nearly close to the pulp;
  • Subjects who is not able to return for the one year follow-up visit because of going abroad or other reasons;
  • Subject is enrolled in other studies on investigational drug or device
  • Cannot tolerate rubber dam isolation. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Beijing Stomatology Hospital of Capital Medical University

Beijing, Beijing Municipality, 010, China

Location

Peking University Hospital of Stomatology

Beijing, Beijing Municipality, 010, China

Location

Hospital of Stomatology Wuhan University

Wuhan, Hubei, 027, China

Location

Results Point of Contact

Title
Xiaoyan Wang
Organization
Peking University Hospital of Stomatology
wangxiaoyanpx@163.com
010-82195525

Study Officials

  • Xiaoyan Wang, Director

    Endodontics department of Peking University hospital of stomatology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2018

First Posted

December 4, 2018

Study Start

October 17, 2017

Primary Completion

November 14, 2019

Study Completion

November 14, 2019

Last Updated

July 21, 2023

Results First Posted

July 21, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)