Clinical trial NCT04307420: Postoperative Pain Following Restoration With Composite Resin Versus Sonic Fill
Official title: Postoperative Pain Following Restoration With Sonic Fill Versus Composite Resin in Children With Deep Carious First Permanent Molar: A Randomized Clinical Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Keywords: First Permanent Molar
Composite
Sonic Fill
Resin Restoration
Pediatric Dentistry
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 32
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Pain
timeFrame: Baseline
Secondary outcomes:
measure: Clinical Evaluation of Restoration (Modified USPHS Criteria)
timeFrame: 3 months, 6 months, 9 months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Nevine Waly, Profesor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.