Dental Caries Class INCT03764059
Clinical Study of Filtek™ Bulk Fill Posterior Restorative in Class I and II Restorations
A study testing Filtek™ Bulk Fill Posterior Restorative and Filtek™ Z350XT Universal Restorative in people with Dental Caries Class I and Dental Caries Class II, run by 3M at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dental Caries Class I, Dental Caries Class II
- What is being tested?
- Filtek™ Bulk Fill Posterior Restorative and Filtek™ Z350XT Universal Restorative
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 3 sitesChina
- Study dates
- 17 Oct 2017to 14 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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 .
Who cannot join
- 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;
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- 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. -
Trial locations and contacts
3 sites in 1 country.
China3 sites
Beijing Stomatology Hospital of Capital Medical University
Beijing, Beijing Municipality, 010
Peking University Hospital of Stomatology
Beijing, Beijing Municipality, 010
Hospital of Stomatology Wuhan University
Wuhan, Hubei, 027
About this study
Official title: A Randomized Multicenter Two-Arm Clinical Study to Evaluate the Safety and Efficacy of Filtek™ Bulk Fill Posterior Restorative in Class I and II Restorations
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.
Read the detailed description
This was a randomized, two- arm, non-inferiority study to evaluate the safety and clinical performance of resin composite, Filtek™ Bulk Fill.
Test apparatus: Apparatus for Test: Filtek™ Bulk Fill Posterior Restorative Apparatus for Control: 3M™ ESPE™ Filtek™ Z350XT, was approved by CFDA in 2010 and had been in the market for 5 years with some validated clinical data.
Sample Size of Subjects: Two-hundred forty (240) patients were expected to be recruited into the study and were randomly assigned to the test group and the control group according to the ratio of 1: 1; thus the number of cases in each group was 120. Finally, a total of 240 subjects were randomly enrolled in the study, including 120 subjects in the test group and 120 subjects in the control group, which met the required sample size.
The study consisted of screening period (initial screening visit, post-preparation screening visit), 1-week follow-up visit and 1-year follow-up visit, during which all the tests required in the protocol would be conducted to select the subjects meeting the criteria for inclusion. The examination and evaluation of the initial screening period were supposed to be completed within 0.5 days. Then investigators would make an appointment with the subjects eligible for the initial screening for cavity preparation and tooth filling, the required time of which depended on the complexity of the tooth problem and would be completed within 0.5 days. Immediate evaluation of relevant indicators were offered to the subjects who were selected and qualified after preparation and patients with qualified score would continue to have the 1-week and 1-year follow-up visits.
Subjects were randomly assigned to either the test group (Filtek™ Bulk Fill Posterior Repository) or the control group (Filtek™ Z350XT) in a central random manner, using the corresponding test product or control product to fill and restore posterior teeth defects (class I or class II cavities).
Since all investigators were required to operate according to instructions, it was clear to them which product a subject was given. However, subjects and clinical evaluators were blinded regarding whether the test product (Filtek™ Bulk Fill Posterior Repository) or the control product (Filtek™ Z350XT) was used by the subjects.
Immediately after restoration placement, at 1 week and 1 year postoperative, two or three clinical evaluators from each site performed the clinical assessment (the third more senior evaluator performed the assessment and determination if the first two evaluators were not in agreement) per China Technical Instruction and Guidance of Resin Composite Restoration Material For CFDA Registration (Technical Instruction and Guidance in short). The clinical acceptable rate of the restoration at 1 year was the primary endpoint in this study.
AE/SAE were collected to evaluate the safety of Filtek™ Bulk Fill. Based on the assessment result, if the clinical acceptance rate of the two groups achieved the clinical acceptable rate defined in the protocol, it indicated that Filtek™ Bulk Fill was efficacious for class 1 and II restorations.
- Conditions
- Dental Caries Class I, Dental Caries Class II
- Being tested
- Filtek™ Bulk Fill Posterior Restorative, Filtek™ Z350XT Universal Restorative
- Keywords
- dental restorative, Composite posterior restorative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Filtek™ Z350XT Universal RestorativeDevice
Also called Filtek™ Supreme Ultra Universal Restorative, Filtek™ Supreme XTE Universal Restorative, Filtek™ Ultimate Universal Restorative
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Filtek™ Z350XT Universal Restorative |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Year after restoration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start17 Oct 2017
- Primary completion14 Nov 2019
- Study completion14 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dental Caries Class IStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3M
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaoyan Wang, Director, Principal investigator, Endodontics department of Peking University hospital of stomatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764059
- Sponsor's protocol ID
- MDI0102
- Status last verified
- Jul 2023
- First submitted
- 3 Dec 2018
- Last updated
- 21 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Multicenter Two-Arm Clinical Study to Evaluate the Safety and Efficacy of Filtek™ Bulk Fill Posterior Restorative in Class I and II Restorations
- ClinicalTrials.gov ID
- NCT03764059
- Acronym / sponsor ID
- MDI0102
- Conditions
- Dental Caries Class I, Dental Caries Class II
- Keywords
- dental restorative, Composite posterior restorative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- 3MIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 14 Nov 2019 (actual)
- Study completion
- 14 Nov 2019 (actual)
- First posted
- 4 Dec 2018 (actual)
- Results
- Posted 21 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This was a randomized, two- arm, non-inferiority study to evaluate the safety and clinical performance of resin composite, Filtek™ Bulk Fill.
Test apparatus: Apparatus for Test: Filtek™ Bulk Fill Posterior Restorative Apparatus for Control: 3M™ ESPE™ Filtek™ Z350XT, was approved by CFDA in 2010 and had been in the market for 5 years with some validated clinical data.
Sample Size of Subjects: Two-hundred forty (240) patients were expected to be recruited into the study and were randomly assigned to the test group and the control group according to the ratio of 1: 1; thus the number of cases in each group was 120. Finally, a total of 240 subjects were randomly enrolled in the study, including 120 subjects in the test group and 120 subjects in the control group, which met the required sample size.
The study consisted of screening period (initial screening visit, post-preparation screening visit), 1-week follow-up visit and 1-year follow-up visit, during which all the tests required in the protocol would be conducted to select the subjects meeting the criteria for inclusion. The examination and evaluation of the initial screening period were supposed to be completed within 0.5 days. Then investigators would make an appointment with the subjects eligible for the initial screening for cavity preparation and tooth filling, the required time of which depended on the complexity of the tooth problem and would be completed within 0.5 days. Immediate evaluation of relevant indicators were offered to the subjects who were selected and qualified after preparation and patients with qualified score would continue to have the 1-week and 1-year follow-up visits.
Subjects were randomly assigned to either the test group (Filtek™ Bulk Fill Posterior Repository) or the control group (Filtek™ Z350XT) in a central random manner, using the corresponding test product or control product to fill and restore posterior teeth defects (class I or class II cavities).
Since all investigators were required to operate according to instructions, it was clear to them which product a subject was given. However, subjects and clinical evaluators were blinded regarding whether the test product (Filtek™ Bulk Fill Posterior Repository) or the control product (Filtek™ Z350XT) was used by the subjects.
Immediately after restoration placement, at 1 week and 1 year postoperative, two or three clinical evaluators from each site performed the clinical assessment (the third more senior evaluator performed the assessment and determination if the first two evaluators were not in agreement) per China Technical Instruction and Guidance of Resin Composite Restoration Material For CFDA Registration (Technical Instruction and Guidance in short). The clinical acceptable rate of the restoration at 1 year was the primary endpoint in this study.
AE/SAE were collected to evaluate the safety of Filtek™ Bulk Fill. Based on the assessment result, if the clinical acceptance rate of the two groups achieved the clinical acceptable rate defined in the protocol, it indicated that Filtek™ Bulk Fill was efficacious for class 1 and II restorations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational device/experimental group: Filtek™ Bulk Fill Posterior Restorative | Experimental | Device: Filtek™ Bulk Fill Posterior RestorativeThe 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. |
| Control device/control group: Filtek™ Z350XT Universal Restorative | Active comparator | Device: Filtek™ Z350XT Universal RestorativeThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Filtek™ Bulk Fill Posterior RestorativeThe 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. | Device | Investigational device/experimental group: Filtek™ Bulk Fill Posterior Restorative |
| Filtek™ Z350XT Universal RestorativeAlso: Filtek™ Supreme Ultra Universal Restorative, Filtek™ Supreme XTE Universal Restorative, Filtek™ Ultimate Universal RestorativeThe 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. | Device | Control device/control group: Filtek™ Z350XT Universal Restorative |
Primary outcome
Clinical Acceptance Rate of Restoration at 1 Year After Replacement
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoyan Wang, Director principal investigator
Endodontics department of Peking University hospital of stomatology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Filtek™ Bulk Fill Posterior Restorative and Filtek™ Z350XT Universal Restorative in people with Dental Caries Class I and Dental Caries Class II, run by 3M at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Acceptance Rate of Restoration at 1 Year After Replacement (time frame: 1 Year after restoration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.