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

Not Applicable

Completed

• Conditions: Class II Dental Restorations
• Interventions: Procedure: SonicFill; Procedure: Bulk fill

• Registration Number: NCT02185573
• Lead Sponsor: Damascus University

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.

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 Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-04
• Study First Submitted QC: 2014-07-04
• Study First Posted: 2014-07-09
• Primary Completion: 2015-07
• Status Verified: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2015-10-02
• Last Update Posted: 2015-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SonicFill technique	SonicFill	SonicFill technique
Bulk fill technique	Bulk fill	Bulk fill technique

Primary Outcome Measures

Name	Time	Method
Change in Color Match	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; 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.
Change in Marginal Integrity	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; 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.
Change in Surface Texture	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: 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.
Change in Restoration Wear	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; 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.
Recurrent dental caries	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: 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.
The Fracture/detachment Status	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: 1. No bulk fracture/detachment is present.; 2. Bulk fracture/ detachment is evident.
Change in gingival status	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; 1. No clinical inflammation is present.; 2. Clinical inflammation is present.

Trial Locations

Locations (1)

Department of Operative Dentistry, University of Damascus Dental School; 🇸🇾 Damascus, Syrian Arab Republic