Evaluation of Two Different Methods of Resin Composite Application In Class II Restorations

Evaluation of Two Different Methods of Resin Composite Application Using Bulk-fill Technique In Class II Restorations

Three clinical groups will be evaluated. Each group of patients will undergo one method of Resin Composite application (multi-layer technique 'control group' - bulk-fill Technique - Sonicfill technique). The restored teeth will be followed-up till one year. A comparison is going to be made between the three groups in relation to the modified United Sates Public Health Service (USPHS) criteria of good restorations.

Study Overview

• Status: Completed
• Conditions: Class II Dental Restorations
• Intervention / Treatment: Procedure: Bulk fill; Procedure: SonicFill

Detailed Description

The modified USPHS criteria include the evaluation of seven characteristics of the restorations: color match, marginal integrity, surface texture, wear of both restoration and antagonist, recurrent dental caries, fracture or detachment, and gingivitis around the abutment.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Damascus, Syrian Arab Republic, DM20AM18
    • Department of Operative Dentistry, University of Damascus Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Cooperated patients.
2. Good general health.
3. Good oral hygiene.
4. Aged 15 to 60 years.
5. Class II restoration (upper or lower)
6. Full erupted teeth.
7. Caries value D3 -D4 according to Daignodent.

Exclusion Criteria:

1. If the caries value according to Daignodent is less than D3 -D4.
2. If the tooth is partially erupted.
3. Class II box-like cavity only without any extensions.
4. Patient outside the required age range (15-60 years).
5. Bad oral hygiene.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Conventional Technique; Multi-layer filling technique
Active Comparator: Bulk fill technique	Procedure: Bulk fill; This is one of the composite restoration application techniques
Experimental: SonicFill technique	Procedure: SonicFill; This is the recent intervention under evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Color Match	Color match; The restoration appears to match the shade and translucency of adjacent tooth tissues.; The restoration does not match the shade and translucency of adjacent tooth tissues, but the mismatch is within the range of tooth shade.; The restoration does not match the shade and translucency of adjacent tooth tissues, and the mismatch is outside the normal range of tooth shade and translucency.	Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.
Change in Marginal Integrity	Marginal integrity; The explorer does not catch when drawn across the surface of the restoration toward the tooth, or, if the explorer does catch, there is no visible crevice along the periphery of the restoration.; The explorer catches and there is visible evidence of crevice, into which the explorer penetrates, indicating that the edge of the restoration does not adapt closely to the tooth structure.; the explorer penetrates a crevice defect.	Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.
Change in Surface Texture	Surface texture: Surface texture is similar to polished enamel as determined by means of a sharp explorer.; Surface texture is gritty similar to a surface subject to a white stone or similar to a composite containing supramicron sizes particles.; Surface pitting is sufficiently coarse to inhibit the continuous movement of an explorer across the surface.	Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.
Change in Restoration Wear	Wear; The restoration is continuation of existing anatomic form or is slightly flattened.; A surface concavity is evident.; There is a loss of restorative substance such that a surface concavity is evident. Replacement or restorative treatment is required.	Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.
Recurrent dental caries	Recurrent dental caries: The restoration is a continuation of existing anatomic form adjacent to the restoration.; There is visual evidence of dark deep discoloration adjacent to the restoration.	Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.
The Fracture/detachment Status	Fracture/detachment: No bulk fracture/detachment is present.; Bulk fracture/ detachment is evident.	Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.
Change in gingival status	Gingival status; No clinical inflammation is present.; Clinical inflammation is present.	Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.

Collaborators and Investigators

• Sponsor: Damascus University
• Investigators: Principal Investigator: Rahaf Alkurdi, DDS MSc, PhD student, Department of Operative Dentistry, University of Damascus Dental School, Damascus; Study Director: Souad Abboud, DDS MSc PhD, Associate Professor, Operative Dentistry Department, University of Damascus Dental School, Damascus

Publications and helpful links

General Publications

• 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.
• Campos EA, Ardu S, Lefever D, Jasse FF, Bortolotto T, Krejci I. Marginal adaptation of class II cavities restored with bulk-fill composites. J Dent. 2014 May;42(5):575-81. doi: 10.1016/j.jdent.2014.02.007. Epub 2014 Feb 18.
• Manhart J, Hickel R. [Bulk-fill-composites. Modern application technique of direct composites for posterior teeth]. Swiss Dent J. 2014;124(1):19-37. French, German.
• Ching K. Deep and fast: Kerr's SonicFill bulk fill composite. HDA Now. 2012 Spring:24-5. No abstract available.
• Furness A, Tadros MY, Looney SW, Rueggeberg FA. Effect of bulk/incremental fill on internal gap formation of bulk-fill composites. J Dent. 2014 Apr;42(4):439-49. doi: 10.1016/j.jdent.2014.01.005. Epub 2014 Jan 27.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: July 4, 2014
• First Submitted That Met QC Criteria: July 4, 2014
• First Posted (Estimate): July 9, 2014

Study Record Updates

• Last Update Posted (Estimate): October 5, 2015
• Last Update Submitted That Met QC Criteria: October 2, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Bulk fill; SonicFill; resin composite application; class II restoration
• Other Study ID Numbers: UDDS-OperDent-01-2014