CClinicalTrials.gg
Status unknownNCT03306602Updated Oct 11, 2017

Clinical Evaluation of Bulk-fill vs Layered Composite Resin in Class I and II Posterior Restorations

An interventional study of Filtek Bulk Fill Posterior Restorative and Filtek Z350 XT in Dental Caries Class I (Disorder) and Dental Caries Class II, sponsored by Melaka Manipal Medical College. Status unknown at 1 site in Malaysia. Per ClinicalTrials.gov, last updated 2017-10-11.

Sponsored by Melaka Manipal Medical College · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Dental Caries Class I (Disorder)
  • Dental Caries Class II

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Keywords

  • Composite Resins
  • Dental Restorations
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Patient presenting with:

  1. Any permanent premolar and molar requiring class I or II restorations;
  2. Good oral hygiene;
  3. Teeth in occlusion having at least one proximal contact with adjacent tooth;
  4. Absence of any periodontal or pulpal pathology;
  5. Absence of pain from the tooth to be restored;
  6. Possible application of rubber dam during treatment

Exclusion criteria

Exclusion Criteria:

  1. Participants with unerupted tooth or partially erupted tooth,
  2. Smoking,
  3. Pregnant patients,
  4. Severe bruxism habit,
  5. Pathological pulpal or periodontal problems,
  6. Fractured or visibly cracked teeth.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Bulk Fill Composite

    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.

    Device: Filtek Bulk Fill Posterior Restorative

  • Active comparator
    Layered Composite

    The control restoration will be filled with Filtek Z350 XT (3M ESPE) using the 2 mm incremental layering technique.

    Device: Filtek Z350 XT

Interventions

  • DeviceFiltek Bulk Fill Posterior Restorative

    Filtek™ Bulk Fill Posterior Restorative is a one-step bulk placement solution for fast and easy posterior resin restorations.

  • DeviceFiltek Z350 XT

    Filtek Z350XT is a material for incremental layered composite resin restorations

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 years

06

Study locations

1 of 1 sites recruiting
  • Melaka Manipal Medical College
    Melaka Tengah, Melaka 75150, Malaysia
    Recruiting
07

References and documents

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 25625133 ↗
  • van 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 27238052 ↗
  • van 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 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03306602
Lead sponsor
Melaka Manipal Medical College
Responsible party
Asst. Prof. Dr. NASIL SAKKIR (Assistant Professor, Department of Conservative Dentistry and Endodontics, Melaka Manipal Medical College) — Principal investigator
First posted
Oct 11, 2017
Start date
Jan 30, 2017
Primary completion
Jan 30, 2019 (estimated)
Completion
Apr 10, 2019 (estimated)
Last update
Oct 11, 2017

Study contacts

Dr. NASIL SAKKIR, BDS, MDS
Contact
nasil.sakkir@manipal.edu.my
0060177431474
Prof. Abdul Rashid Hj Ismail, BDS,MSc,DDPH
study chair · Melaka Manipal Medical College

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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