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

Not Applicable

Completed

• Conditions: Dental Restoration Failure of Marginal Integrity
• Interventions: Other: Restoration

• Registration Number: NCT05551130
• Lead Sponsor: Necmettin Erbakan University

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-08-01
• Primary Completion: 2020-08-16
• Study Completion: 2021-08-01
• Status Verified: 2022-09
• Study First Submitted: 2022-09-19
• Study First Submitted QC: 2022-09-19
• Study First Posted: 2022-09-22
• Last Update Submitted: 2022-09-22
• Last Update Posted: 2022-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Equia Group	Restoration	Equia system bulk fill glass hybrid material
Charisma Group	Restoration	Charisma Smart universal composite resin

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Merve Abakli Inci; 🇹🇷 Konya, Turkey