Postoperative Pain Following Restoration With Composite Resin Versus Sonic Fill

NCT ID: NCT04307420

Last Updated: 2020-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-06-01

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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Sonic Fill Restoration

Intervention Type PROCEDURE

Kerr's Sonic Fill is the only sonic-activated, single-step, bulk-fill composite that starts out as a low-viscosity composite.

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.

Group Type ACTIVE_COMPARATOR

Composite Resin Restoration

Intervention Type PROCEDURE

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.

Interventions

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Sonic Fill Restoration

Kerr's Sonic Fill is the only sonic-activated, single-step, bulk-fill composite that starts out as a low-viscosity composite.

Intervention Type PROCEDURE

Composite Resin Restoration

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.

Intervention Type PROCEDURE

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mennatallah Samy Mohamed Maklad

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nevine Waly, Profesor

Role: STUDY_DIRECTOR

Cairo University

Central Contacts

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Mennatallah S Maklad, Masters

Role: CONTACT

+201015556040

Fatma K Abdelgawad, Professor

Role: CONTACT

+201006753265

References

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Chandrasekhar V, Rudrapati L, Badami V, Tummala M. Incremental techniques in direct composite restoration. J Conserv Dent. 2017 Nov-Dec;20(6):386-391. doi: 10.4103/JCD.JCD_157_16.

Reference Type BACKGROUND
PMID: 29430088 (View on PubMed)

Afifi SMH, Haridy MF, Farid MR. Evaluation of Post-Operative Sensitivity of Bulk Fill Resin Composite versus Nano Resin Composite: A Randomized Controlled Clinical Study. Open Access Maced J Med Sci. 2019 Jul 26;7(14):2335-2342. doi: 10.3889/oamjms.2019.656. eCollection 2019 Jul 30.

Reference Type BACKGROUND
PMID: 31592052 (View on PubMed)

Atabek D, Aktas N, Sakaryali D, Bani M. Two-year clinical performance of sonic-resin placement system in posterior restorations. Quintessence Int. 2017;48(9):743-751. doi: 10.3290/j.qi.a38855.

Reference Type RESULT
PMID: 28849804 (View on PubMed)

Other Identifiers

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Composite Resin VS Sonic Fill

Identifier Type: -

Identifier Source: org_study_id

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