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

Dental Restoration Failure of Marginal Integrity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05551130
• Other study ID #: 2020/332
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: September 2022
• Source: Necmettin Erbakan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 1, 2021
• Est. primary completion date: August 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Restoration Failure of Marginal Integrity

Intervention

Other:
• Restoration
Restorations completed with these materials.

Locations

Country	Name	City	State
Turkey	Merve Abakli Inci	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Necmettin Erbakan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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