Postoperative Pain Following Restoration With Composite Resin Versus Sonic Fill

Study Overview
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Brief Summary
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The aim of this study is to assess the postoperative pain following restoration with composite resin versus sonic fill in children with deep carious first permanent molar.

Detailed Description
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For many years, composite resin restorations have been considered an acceptable treatment choice for anterior applications. Recent advances in composite resin mechanical properties and improved adhesive systems have broadened the application of these materials to include the restoration of posterior teeth. However, it is still generally accepted that posterior composite resin restorations have limitations and that there is no ideal material available. A volumetric shrinkage occurs when a composite resin material is cured. The shrinkage is the result of conversion of monomer molecules into a more dense polymer network, which leads to bulk contraction. A new nanohybrid composite activated by sonic energy has been recently introduced as a single-step, bulk-fill restorative material. This system utilizes the patented sonic-activation technology enabling a rapid flow of composite into the cavity for effortless placement and superior adaptation in one single layer, thereby, emphasizes its practical and efficient technique for placing posterior composites. The hand piece, designed by KaVo (Germany), delivers sonic energy at varying intensities, which is adjusted on the shank from low to high (1 to 5) to control rate of composite extrusion.

Official Title
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Postoperative Pain Following Restoration With Sonic Fill Versus Composite Resin in Children With Deep Carious First Permanent Molar: A Randomized Clinical Pilot Study

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: Sonic Fill Restoration
* Procedure: Composite Resin Restoration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Asymptomatic First Permanent Molar Age of the patient ranging from 6-9 years Normal periodontal status Teeth with no previous restorative treatment Good oral health Absences of pathological mobility Exclusion Criteria: Adverse medical history Potential behavioral problems Parents refusing participation of their children

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sonic Fill Restoration<br>Using sonic activation system turns the highly filled sonic fill composite into a flowable which enables the material to rapidly fill the cavity effortlessly- greatly reducing procedure time. | Procedure: Sonic Fill Restoration<br>* Kerr's Sonic Fill is the only sonic-activated, single-step, bulk-fill composite that starts out as a low-viscosity composite.<br>|
| Active Comparator: Composite Resin Restoration<br>Direct composite restorations are the most requested and performed dental procedures. The incremental placement technique is the gold standard for posterior universal composite placement. | Procedure: Composite Resin Restoration<br>* Composite resins are polymer-based materials used in dentistry for aesthetic repairs.Polymerization is accomplished typically with a hand held curing light that emits specific wavelengths keyed to the initiator and catalyst packages involved.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain | The primary outcome (postoperative pain) is evaluated the following day of the treatment performed by a phone call from the outcome assessor, a week and a month after to check in any pain. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Evaluation of Restoration (Modified USPHS Criteria) | The secondary outcome (USPHS) is evaluated by the outcome assessor and an investigator using the given scores as follows: The modified United States Public Health Service (USPHS) criteria for retention, color matching, marginal discoloration, marginal adaptation, secondary caries, surface texture and anatomical form were used. | 3 months, 6 months, 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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First Permanent Molar, Composite, Sonic Fill, Resin Restoration, Pediatric Dentistry