Postoperative Pain Following Restoration With Composite Resin Versus Sonic Fill
Primary Purpose
Postoperative Pain
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sonic Fill Restoration
Composite Resin Restoration
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring First Permanent Molar, Composite, Sonic Fill, Resin Restoration, Pediatric Dentistry
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sonic Fill Restoration
Composite Resin Restoration
Arm Description
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.
Direct composite restorations are the most requested and performed dental procedures. The incremental placement technique is the gold standard for posterior universal composite placement.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04307420
Brief Title
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
May 31, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
First Permanent Molar, Composite, Sonic Fill, Resin Restoration, Pediatric Dentistry
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sonic Fill Restoration
Arm Type
Experimental
Arm Description
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.
Arm Title
Composite Resin Restoration
Arm Type
Active Comparator
Arm Description
Direct composite restorations are the most requested and performed dental procedures. The incremental placement technique is the gold standard for posterior universal composite placement.
Intervention Type
Procedure
Intervention Name(s)
Sonic Fill Restoration
Intervention Description
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
Intervention Name(s)
Composite Resin Restoration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative Pain
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Clinical Evaluation of Restoration (Modified USPHS Criteria)
Description
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.
Time Frame
3 months, 6 months, 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mennatallah S Maklad, Masters
Phone
+201015556040
Email
menna.maklad@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fatma K Abdelgawad, Professor
Phone
+201006753265
Email
fatmadent@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nevine Waly, Profesor
Organizational Affiliation
Cairo University
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
29430088
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.
Results Reference
background
PubMed Identifier
31592052
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.
Results Reference
background
PubMed Identifier
28849804
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.
Results Reference
result
Learn more about this trial
Postoperative Pain Following Restoration With Composite Resin Versus Sonic Fill
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