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

NCT02185573 | Completed DMC

• 1 other identifier: UDDS-OperDent-01-2014
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Class II Dental Restorations

Keywords

Bulk fill; SonicFill; resin composite application; class II restoration

Outcome Measures

Primary Outcomes (7)

• Change in Color Match

  Color match 1. The restoration appears to match the shade and translucency of adjacent tooth tissues. 2. The restoration does not match the shade and translucency of adjacent tooth tissues, but the mismatch is within the range of tooth shade. 3. 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 1. 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. 2. 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. 3. 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: 1. Surface texture is similar to polished enamel as determined by means of a sharp explorer. 2. Surface texture is gritty similar to a surface subject to a white stone or similar to a composite containing supramicron sizes particles. 3. 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 1. The restoration is continuation of existing anatomic form or is slightly flattened. 2. A surface concavity is evident. 3. 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: 1. The restoration is a continuation of existing anatomic form adjacent to the restoration. 2. 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: 1. No bulk fracture/detachment is present. 2. 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 1. No clinical inflammation is present. 2. 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.

Study Arms (3)

Conventional Technique

NO INTERVENTION

Multi-layer filling technique

Bulk fill technique

ACTIVE COMPARATOR

Bulk fill technique

Procedure: Bulk fill

SonicFill technique

EXPERIMENTAL

SonicFill technique

Procedure: SonicFill

Interventions

Bulk fill PROCEDURE

This is one of the composite restoration application techniques

Bulk fill technique

SonicFill PROCEDURE

This is the recent intervention under evaluation

SonicFill technique

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Cooperated patients.
• Good general health.
• Good oral hygiene.
• Aged 15 to 60 years.
• Class II restoration (upper or lower)
• Full erupted teeth.
• Caries value D3 -D4 according to Daignodent.

You may not qualify if:

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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Operative Dentistry, University of Damascus Dental School

Damascus, Rif-dimashq Governorate, DM20AM18, Syria

Location

Related Publications (5)

• Manhart J, Hickel R. [Bulk-fill-composites. Modern application technique of direct composites for posterior teeth]. Swiss Dent J. 2014;124(1):19-37. doi: 10.61872/sdj-2014-01-02. French, German.

  PMID: 24665478 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

• Ching K. Deep and fast: Kerr's SonicFill bulk fill composite. HDA Now. 2012 Spring:24-5. No abstract available.

  PMID: 22984718 BACKGROUND

• 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.

  PMID: 24480086 BACKGROUND

• 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.

  PMID: 24561041 BACKGROUND

MeSH Terms

Interventions

Filtek Bulk Fill; SonicFill

Study Officials

• Rahaf Alkurdi, DDS MSc

  PhD student, Department of Operative Dentistry, University of Damascus Dental School, Damascus

  PRINCIPAL INVESTIGATOR

• Souad Abboud, DDS MSc PhD

  Associate Professor, Operative Dentistry Department, University of Damascus Dental School, Damascus

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: July 9, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 5, 2015

Record last verified: 2015-10

Locations

SY (1)