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

NCT03306602 | Unknown DMC FDA Device

• 1 other identifier: MMMC/FOD/AR/B5/ E C-2017(26)
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Composite Resins; Dental Restorations

Outcome Measures

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.

  2 years

Study Arms (2)

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.

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.

Device: Filtek Z350 XT

Interventions

Filtek Bulk Fill Posterior Restorative DEVICE

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

Bulk Fill Composite

Filtek Z350 XT DEVICE

Filtek Z350XT is a material for incremental layered composite resin restorations

Layered Composite

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Participants with unerupted tooth or partially erupted tooth,
• Smoking,
• Pregnant patients,
• Severe bruxism habit,
• Pathological pulpal or periodontal problems,
• Fractured or visibly cracked teeth.

Sponsors & Collaborators

• Melaka Manipal Medical College: lead

Study Sites (1)

Melaka Manipal Medical College

Melaka Tengah, Melaka, 75150, Malaysia

RECRUITING

Related Publications (3)

• 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.

  PMID: 25625133 BACKGROUND

• 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.

  PMID: 27238052 BACKGROUND

• 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.

  PMID: 24958689 BACKGROUND

Related Links

• Modified United States Public Health Service (USPHS) Ryge Criteria for Direct Clinical Evaluation of Restoration

Study Officials

• Prof. Abdul Rashid Hj Ismail, BDS,MSc,DDPH

  Melaka Manipal Medical College

  STUDY CHAIR

Central Study Contacts

Dr. NASIL SAKKIR, BDS, MDS

CONTACT

0060177431474; nasil.sakkir@manipal.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Conservative Dentistry and Endodontics

Model Details: 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.

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: October 11, 2017
• Study Start: January 30, 2017
• Primary Completion: January 30, 2019
• Study Completion: April 10, 2019
• Last Updated: October 11, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)