Postoperative Pain Following Restoration With Composite Resin Versus Sonic Fill

Not Applicable

• Conditions: Postoperative Pain
• Interventions: Procedure: Composite Resin Restoration; Procedure: Sonic Fill Restoration

• Registration Number: NCT04307420
• Lead Sponsor: Cairo University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-03-11
• Study First Submitted QC: 2020-03-12
• Study First Posted: 2020-03-13
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-14
• Last Update Posted: 2020-07-16
• Study Start: 2020-09-01
• Primary Completion: 2021-05-31
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Composite Resin Restoration	Composite Resin Restoration	Direct composite restorations are the most requested and performed dental procedures. The incremental placement technique is the gold standard for posterior universal composite placement.
Sonic Fill Restoration	Sonic Fill Restoration	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.

Primary Outcome Measures

Name	Time	Method
Postoperative Pain	Baseline	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.

Secondary Outcome Measures

Name	Time	Method
Clinical Evaluation of Restoration (Modified USPHS Criteria)	3 months, 6 months, 9 months	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.