Dental Caries Class I (Disorder)NCT03306602
Clinical Evaluation of Bulk-fill vs Layered Composite Resin in Class I and II Posterior Restorations
A study testing Filtek Bulk Fill Posterior Restorative and Filtek Z350 XT in people with Dental Caries Class I (Disorder) and Dental Caries Class II, run by Melaka Manipal Medical College at 1 site in Malaysia.
Trial summary
The aim of this study is to evaluate the clinical performance of Filtek Bulk Fill Posterior Restorative in Class I and Class II restorations compared to the conventional incremental technique using Filtek Z350XT over the period of 2 years. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dental Caries Class I (Disorder), Dental Caries Class II
- What is being tested?
- Filtek Bulk Fill Posterior Restorative and Filtek Z350 XT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteMalaysia
- Study dates
- 30 Jan 2017to 10 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patient presenting with:
- Any permanent premolar and molar requiring class I or II restorations;
- Good oral hygiene;
- Teeth in occlusion having at least one proximal contact with adjacent tooth;
- Absence of any periodontal or pulpal pathology;
- Absence of pain from the tooth to be restored;
- Possible application of rubber dam during treatment
Who cannot join
- Participants with unerupted tooth or partially erupted tooth,
- Smoking,
- Pregnant patients,
- Severe bruxism habit,
- Pathological pulpal or periodontal problems,
- Fractured or visibly cracked teeth.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Melaka Manipal Medical College
Melaka Tengah, Melaka, 75150
Dr. Nasil Sakkir, 00606292 5849 ext. 3828, nasil.sakkir@manipal.edu.my
About this study
Official title: Clinical Evaluation of Bulk-fill vs Layered Composite Resin in Class I and II Posterior Restorations: A Randomized Controlled Pilot Study
The aim of this study is to evaluate the clinical performance of Filtek Bulk Fill Posterior Restorative in Class I and Class II restorations compared to the conventional incremental technique using Filtek Z350XT over the period of 2 years. The null hypothesis of this study is that the bulk-fill composite will exhibit same result and clinical performance as conventional composite using incremental technique which has been used widely by dentists nowadays.
Read the detailed description
In recent years, people are more concerned with the aesthetic qualities of dental restorations and in response to enhancements in the resin technologies, tooth-colored resin composite materials are increasingly being used for posterior teeth instead of amalgam fillings. Developments during the years in chemical composition, filler reinforcement, and adhesive techniques have resulted in many new modified categories of materials. Some researchers recommend the use of the incremental technique, in which the composite material is gradually placed in layers of 2mm or less.
This approach to restore teeth has a number of advantages, for example, it results in better light penetration and better polymerization of composite resin, reduction in cavity configuration factor, reduction in polymerization shrinkage stress and ensures that the resin adheres to the cavity walls. During curing of the resin, a network of polymers is formed, which becomes rigid due to increased cross linking of the polymer chains. Decreasing mobility of the network causes further shrinkage and results in a strain on the resin composite and cavity margins. The resulting stress has been associated with marginal deficiencies, enamel fractures, cuspal movement, and cracked cusps, which in turn may result in microleakage, post-operative sensitivity, and secondary caries. It has been stated that posterior class II and especially class I cavities with a high C-factor will result in greater stresses due to a larger number of bonded surfaces.
However, there are number of disadvantages associated with the use of an incremental approach to place the resin. For example, voids can be trapped in between the increments, bonding failure can occur in between the increments, difficulty in placing the composite material after cavity preparation and the long time taken for the procedure. In an effort to counter these problems, a new restorative material has been introduced in 2009 which is known as 'bulk-fill' composite, in order to increase efficiency of the operator. However, many clinicians who have accustomed to the incremental cure philosophy when placing the light-cured composite quite rightly question what has been changed to make these bulk-fill light-cured composite a variable alternative. According to some researchers, bulk-fill composite offers more advantages compared to the layered composite. These include increased efficiency in working time, reduced polymerization shrinkage and reduces the risk of contamination and voids forming between the resins.
The aim of this study is to evaluate the clinical performance of bulk-fill composite as compared to the layered composite technique in class I and class II restorations over the period of 2 years.
- Being tested
- Filtek Bulk Fill Posterior Restorative, Filtek Z350 XT
- Keywords
- Composite Resins, Dental Restorations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filtek Bulk Fill Posterior RestorativeDevice
Filtek™ Bulk Fill Posterior Restorative is a one-step bulk placement solution for fast and easy posterior resin restorations.
Filtek Z350 XTDevice
Filtek Z350XT is a material for incremental layered composite resin restorations
| Study group | Role | What they receive |
|---|---|---|
| Bulk Fill Composite | Experimental | In the experimental cavity, Filtek Bulk Fill Posterior Restorative (3M ESPE) will be placed in 5 mm increments, eliminating the need for additional layers or multiple steps. Receives: Device: Filtek Bulk Fill Posterior Restorative |
| Layered Composite | Active comparator | The control restoration will be filled with Filtek Z350 XT (3M ESPE) using the 2 mm incremental layering technique. Receives: Device: Filtek Z350 XT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified United States Public Health Services (USPHS) criteria
All the restorations will be analyzed by using Modified United States Public Health Services (USPHS) criteria, focusing more on the clinical criteria of the restoration. The characteristics of all the restorations will be described by using descriptive statistics using cumulative frequency distributions of the scores.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start30 Jan 2017
- Primary completion30 Jan 2019 (estimated)
- Study completion10 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dental Caries Class I (Disorder)Studies 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
- Model description
- All the participants will receive both the experimental and control restoration. In the experimental cavity, Filtek Bulk Fill Posterior Restorative (3M ESPE) will be placed in 5 mm increments, eliminating the need for additional layers or multiple steps. The control restoration will be filled with Filtek Z350 XT (3M ESPE) using the 2 mm incremental layering technique.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Melaka Manipal Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asst. Prof. Dr. NASIL SAKKIR, Melaka Manipal Medical College
- Investigators
- Prof. Abdul Rashid Hj Ismail, BDS,MSc,DDPH, Study chair, Melaka Manipal Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306602
- Sponsor's protocol ID
- MMMC/FOD/AR/B5/ E C-2017(26)
- Status last verified
- Oct 2017
- First submitted
- 3 Oct 2017
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
van Dijken JW, Pallesen U. Randomized 3-year clinical evaluation of Class I and II posterior resin restorations placed with a bulk-fill resin composite and a one-step self-etching adhesive. J Adhes Dent. 2015 Feb;17(1):81-8. doi: 10.3290/j.jad.a33502.
PubMed 25625133van Dijken JW, Pallesen U. Posterior bulk-filled resin composite restorations: A 5-year randomized controlled clinical study. J Dent. 2016 Aug;51:29-35. doi: 10.1016/j.jdent.2016.05.008. Epub 2016 May 26.
PubMed 27238052van Dijken JW, Pallesen U. A randomized controlled three year evaluation of "bulk-filled" posterior resin restorations based on stress decreasing resin technology. Dent Mater. 2014 Sep;30(9):e245-51. doi: 10.1016/j.dental.2014.05.028. Epub 2014 Jun 21.
PubMed 24958689
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Bulk-fill vs Layered Composite Resin in Class I and II Posterior Restorations: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT03306602
- Acronym / sponsor ID
- MMMC/FOD/AR/B5/ E C-2017(26)
- Keywords
- Composite Resins, Dental Restorations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Melaka Manipal Medical CollegeUniversity, hospital or other
- Study start
- 30 Jan 2017 (actual)
- Primary completion
- 30 Jan 2019 (estimated)
- Study completion
- 10 Apr 2019 (estimated)
- First posted
- 11 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the clinical performance of Filtek Bulk Fill Posterior Restorative in Class I and Class II restorations compared to the conventional incremental technique using Filtek Z350XT over the period of 2 years. The null hypothesis of this study is that the bulk-fill composite will exhibit same result and clinical performance as conventional composite using incremental technique which has been used widely by dentists nowadays.
Detailed description
In recent years, people are more concerned with the aesthetic qualities of dental restorations and in response to enhancements in the resin technologies, tooth-colored resin composite materials are increasingly being used for posterior teeth instead of amalgam fillings. Developments during the years in chemical composition, filler reinforcement, and adhesive techniques have resulted in many new modified categories of materials. Some researchers recommend the use of the incremental technique, in which the composite material is gradually placed in layers of 2mm or less.
This approach to restore teeth has a number of advantages, for example, it results in better light penetration and better polymerization of composite resin, reduction in cavity configuration factor, reduction in polymerization shrinkage stress and ensures that the resin adheres to the cavity walls. During curing of the resin, a network of polymers is formed, which becomes rigid due to increased cross linking of the polymer chains. Decreasing mobility of the network causes further shrinkage and results in a strain on the resin composite and cavity margins. The resulting stress has been associated with marginal deficiencies, enamel fractures, cuspal movement, and cracked cusps, which in turn may result in microleakage, post-operative sensitivity, and secondary caries. It has been stated that posterior class II and especially class I cavities with a high C-factor will result in greater stresses due to a larger number of bonded surfaces.
However, there are number of disadvantages associated with the use of an incremental approach to place the resin. For example, voids can be trapped in between the increments, bonding failure can occur in between the increments, difficulty in placing the composite material after cavity preparation and the long time taken for the procedure. In an effort to counter these problems, a new restorative material has been introduced in 2009 which is known as 'bulk-fill' composite, in order to increase efficiency of the operator. However, many clinicians who have accustomed to the incremental cure philosophy when placing the light-cured composite quite rightly question what has been changed to make these bulk-fill light-cured composite a variable alternative. According to some researchers, bulk-fill composite offers more advantages compared to the layered composite. These include increased efficiency in working time, reduced polymerization shrinkage and reduces the risk of contamination and voids forming between the resins.
The aim of this study is to evaluate the clinical performance of bulk-fill composite as compared to the layered composite technique in class I and class II restorations over the period of 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- All the participants will receive both the experimental and control restoration. In the experimental cavity, Filtek Bulk Fill Posterior Restorative (3M ESPE) will be placed in 5 mm increments, eliminating the need for additional layers or multiple steps. The control restoration will be filled with Filtek Z350 XT (3M ESPE) using the 2 mm incremental layering technique.
| Arm | Type | Receives |
|---|---|---|
| Bulk Fill Composite | Experimental | Device: Filtek Bulk Fill Posterior RestorativeIn the experimental cavity, Filtek Bulk Fill Posterior Restorative (3M ESPE) will be placed in 5 mm increments, eliminating the need for additional layers or multiple steps. |
| Layered Composite | Active comparator | Device: Filtek Z350 XTThe control restoration will be filled with Filtek Z350 XT (3M ESPE) using the 2 mm incremental layering technique. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Any permanent premolar and molar requiring class I or II restorations;
- Good oral hygiene;
- Teeth in occlusion having at least one proximal contact with adjacent tooth;
- Absence of any periodontal or pulpal pathology;
- Absence of pain from the tooth to be restored;
Key exclusion criteria (6 listed)
- Participants with unerupted tooth or partially erupted tooth,
- Smoking,
- Pregnant patients,
- Severe bruxism habit,
- Pathological pulpal or periodontal problems,
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 RestorativeFiltek™ Bulk Fill Posterior Restorative is a one-step bulk placement solution for fast and easy posterior resin restorations. | Device | Bulk Fill Composite |
| Filtek Z350 XTFiltek Z350XT is a material for incremental layered composite resin restorations | Device | Layered Composite |
Primary outcome
Modified United States Public Health Services (USPHS) criteria
Time frame: 2 years
All the restorations will be analyzed by using Modified United States Public Health Services (USPHS) criteria, focusing more on the clinical criteria of the restoration. The characteristics of all the restorations will be described by using descriptive statistics using cumulative frequency distributions of the scores.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
- Background: PubMed 25625133van Dijken JW, Pallesen U. Randomized 3-year clinical evaluation of Class I and II posterior resin restorations placed with a bulk-fill resin composite and a one-step self-etching adhesive. J Adhes Dent. 2015 Feb;17(1):81-8. doi: 10.3290/j.jad.a33502.
- Background: PubMed 27238052van Dijken JW, Pallesen U. Posterior bulk-filled resin composite restorations: A 5-year randomized controlled clinical study. J Dent. 2016 Aug;51:29-35. doi: 10.1016/j.jdent.2016.05.008. Epub 2016 May 26.
- Background: PubMed 24958689van Dijken JW, Pallesen U. A randomized controlled three year evaluation of "bulk-filled" posterior resin restorations based on stress decreasing resin technology. Dent Mater. 2014 Sep;30(9):e245-51. doi: 10.1016/j.dental.2014.05.028. Epub 2014 Jun 21.
- Modified United States Public Health Service (USPHS) Ryge Criteria for Direct Clinical Evaluation of RestorationLink provided by the sponsor.
- 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.
Prof. Abdul Rashid Hj Ismail, BDS,MSc,DDPH study chair
Melaka Manipal Medical College
1 site 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 Z350 XT in people with Dental Caries Class I (Disorder) and Dental Caries Class II, run by Melaka Manipal Medical College at 1 site in Malaysia.
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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 11 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. NASIL SAKKIR, BDS, MDS (0060177431474, nasil.sakkir@manipal.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified United States Public Health Services (USPHS) criteria (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03306602, which also lists 3 linked publications.
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 11 Oct 2017.