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

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ClinicalTrials.gov Identifier: NCT03306602
Recruitment Status : Recruiting
First Posted : October 11, 2017
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):
Asst. Prof. Dr. NASIL SAKKIR, Melaka Manipal Medical College

Brief 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.

Condition or disease Intervention/treatment Phase
Dental Caries Class I (Disorder) Dental Caries Class II Device: Filtek Bulk Fill Posterior Restorative Device: Filtek Z350 XT Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Investigator, Outcomes Assessor)
Masking Description: The cavity in an individual will be randomly assigned to either the experimental or the control restoration, according to a predetermined scheme of randomization. If the participants have two cavities, they will not know in which cavity the experimental and control restoration were placed. All the restorations will be analyzed by using Modified United States Public Health Services (USPHS) criteria. The investigators and outcome assessors evaluating the restorations will not know which tooth has been restored with the experimental or control restoration
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Bulk-fill vs Layered Composite Resin in Class I and II Posterior Restorations: A Randomized Controlled Pilot Study
Actual Study Start Date : January 30, 2017
Estimated Primary Completion Date : January 30, 2019
Estimated Study Completion Date : April 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

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

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
Filtek Z350XT is a material for incremental layered composite resin restorations




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03306602


Contacts
Contact: Dr. NASIL SAKKIR, BDS, MDS 0060177431474 nasil.sakkir@manipal.edu.my

Locations
Malaysia
Melaka Manipal Medical College Recruiting
Melaka Tengah, Melaka, Malaysia, 75150
Contact: Dr. Nasil Sakkir    00606292 5849 ext 3828    nasil.sakkir@manipal.edu.my   
Sponsors and Collaborators
Melaka Manipal Medical College
Investigators
Study Chair: Prof. Abdul Rashid Hj Ismail, BDS,MSc,DDPH Melaka Manipal Medical College

Additional Information:
Publications:
Responsible Party: Asst. Prof. Dr. NASIL SAKKIR, Assistant Professor, Department of Conservative Dentistry and Endodontics, Melaka Manipal Medical College
ClinicalTrials.gov Identifier: NCT03306602     History of Changes
Other Study ID Numbers: MMMC/FOD/AR/B5/ E C-2017(26)
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Asst. Prof. Dr. NASIL SAKKIR, Melaka Manipal Medical College:
Composite Resins
Dental Restorations

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Z 350
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs