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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Class II Dental Restorations

Intervention / Treatment
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* Procedure: Bulk fill
* Procedure: SonicFill


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bulk fill, SonicFill, resin composite application, class II restoration