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Completed

NCT Number: NCT02185573

Evaluation of Two Different Methods of Resin Composite Application 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.

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Key information

Conditions

Class II Dental Restorations

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Operative Dentistry, University of Damascus Dental School

Damascus, Rif-dimashq Governorate, DM20AM18, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Bulk fill

Procedure

This is one of the composite restoration application techniques

SonicFill

Procedure

This is the recent intervention under evaluation

Primary outcomes

  1. Change in Color Match

    Time frame: 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.

    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.

  2. Change in Marginal Integrity

    Time frame: 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.

    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.

  3. Change in Surface Texture

    Time frame: 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.

    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.

  4. Change in Restoration Wear

    Time frame: 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.

    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.

  5. Recurrent dental caries

    Time frame: 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:

    • 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.

  6. The Fracture/detachment Status

    Time frame: 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.

    Fracture/detachment:

    • No bulk fracture/detachment is present.
    • Bulk fracture/ detachment is evident.

  7. Change in gingival status

    Time frame: 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.

    Gingival status

    • No clinical inflammation is present.
    • Clinical inflammation is present.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 9, 2014
Registry last updated
Oct 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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