Could Bulk Fill Glass Hybrid Restorative Materials Replace Composite Resins in Treating Permanent Teeth?

Study Overview
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Brief Summary
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The aim of this study is to compare the clinical and radiographic efficacy of Equia system bulk fill glass hybrid material with composite resins in the permanent restoration of pediatric patients' permanent teeth.

Detailed Description
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The study included 44 pediatric patients aged 8 to 16 years who applied to the Pedodontics Department of the Necmettin Erbakan University Faculty of Dentistry. The groups were formed as symmetrical teeth in the same patient using the split-mouth design. The study included class I caries lesions of 144 permanent teeth, 72 of which were restored with the Equia system bulk fill glass hybrid material [Equia Forte HT+Equia Forte Coat (GC, Co, Tokyo, Japan)] and 72 with the Charisma Smart universal composite resin (Kulzer, Gmbh, Hanau, Germany) + Clearfil SE Bond (Kuraray, Noritake, Sakazu, Okayama). Evaluations were performed clinically and radiographically by 2 physicians in the 2nd week, 3rd month, 6th month, and 12th month and the results were recorded. Clinical evaluation was carried out using modified USPHS criteria. Obtained data were statistically analyzed using Kendall's W test and Cochran's Q test for the comparison within the group, and the Chi-Square test for the comparison between the groups.

Official Title
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Is There a Possibility That Bulk Fill Glass Hybrid Restorative Materials Could Replace Composite Resins in Treating Permanent Teeth? : A Randomized Controlled Clinical Trial

Conditions
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Dental Restoration Failure of Marginal Integrity

Intervention / Treatment
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* Other: Restoration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient has no systemic disease The patient should have good periodontal status Teeth to be restored should be symptomless and vital Teeth to be restored should have proximal contacts on both mesial and distal surfaces and be in occlusion with the antagonist teeth Teeth that have class II caries lesions in external and middle 1/3 of dentine thickness radiographically Exclusion Criteria: Xerostomia and bruxism; Absence of adjacent and antagonist teeth; Extremely poor oral hygiene, severe or chronic periodontitis; Teeth that have any restoration, endodontic treatment, periodontal and periapical pathology. The patients who are undergoing orthodontic treatment

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Equia Group<br>Equia system bulk fill glass hybrid material | Other: Restoration<br>* Restorations completed with these materials.<br>* Other names: Restorative Interventions;|
| Active Comparator: Charisma Group<br>Charisma Smart universal composite resin | Other: Restoration<br>* Restorations completed with these materials.<br>* Other names: Restorative Interventions;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| marginal adaptation | According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted. The scale: Alfa Bravo Charlie | 2 weeks-12 months | 
| marginal discoloration | According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted. The scale: Alfa Bravo Charlie | 2 weeks-12 months | 
| color match | According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted. The scale: Alfa Bravo Charlie | 2 weeks-12 months | 
| surface texture | According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted. The scale: Alfa Bravo Charlie | 2 weeks-12 months | 
| secondary caries | According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted. The scale: Alfa Bravo Charlie | 2 weeks-12 months | 
| postoperative sensitivity | According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted. The scale: Alfa Bravo Charlie | 2 weeks-12 months | 
| retention | According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted. The scale: Alfa Bravo Charlie | 2 weeks-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anatomic form | According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted. The scale: Alfa Bravo Charlie | 2 weeks-12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Composite Resins, Clinical Trial, Glass Ionomer Cements, Permanent Dental Restoration