Postoperative Pain Following Restoration With Composite Resin Versus Sonic Fill

• Sponsor: Cairo University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04307420
• Collaborator: (none)
• Enrollment: 32
• Arms: 2
• Anticipated Duration (Months): 9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Procedure: Sonic Fill Restoration; Procedure: Composite Resin Restoration	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Sep 1, 2020
• Anticipated Primary Completion Date: May 31, 2021
• Anticipated Study Completion Date: Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Procedure: 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.
Active Comparator: 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.	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 9 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Cairo University

Investigators

• Study Director: Nevine Waly, Profesor, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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. Review.

• Responsible Party: Mennatallah Samy Mohamed Maklad, Principle Investigator, Cairo University
• ClinicalTrials.gov Identifier: NCT04307420
• Other Study ID Numbers: Composite Resin VS Sonic Fill
• First Posted: Mar 13, 2020
• Last Update Posted: Jul 16, 2020
• Last Verified: Jul 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mennatallah Samy Mohamed Maklad, Principle Investigator, Cairo University: First Permanent Molar; Composite; Sonic Fill; Resin Restoration; Pediatric Dentistry
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

No Results Posted as of Jul 16, 2020