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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05551130
Enrollment
44
Registered
2022-09-22
Start date
2020-08-01
Completion date
2021-08-01
Last updated
2022-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Restoration Failure of Marginal Integrity

Keywords

Composite Resins, Clinical Trial, Glass Ionomer Cements, Permanent Dental Restoration

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.

Interventions

Restorations completed with these materials.

Sponsors

Necmettin Erbakan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
8 Years to 16 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
retention2 weeks-12 monthsAccording to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted. The scale: Alfa Bravo Charlie
marginal adaptation2 weeks-12 monthsAccording to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted. The scale: Alfa Bravo Charlie
marginal discoloration2 weeks-12 monthsAccording to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted. The scale: Alfa Bravo Charlie
color match2 weeks-12 monthsAccording to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted. The scale: Alfa Bravo Charlie
surface texture2 weeks-12 monthsAccording to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted. The scale: Alfa Bravo Charlie
secondary caries2 weeks-12 monthsAccording to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted. The scale: Alfa Bravo Charlie
postoperative sensitivity2 weeks-12 monthsAccording to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted. The scale: Alfa Bravo Charlie

Secondary

MeasureTime frameDescription
anatomic form2 weeks-12 monthsAccording to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted. The scale: Alfa Bravo Charlie

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026