Clinical trial NCT05551130: Could Bulk Fill Glass Hybrid Restorative Materials Replace Composite Resins in Treating Permanent Teeth?
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Restoration Failure of Marginal Integrity
Keywords: Composite Resins
Clinical Trial
Glass Ionomer Cements
Permanent Dental Restoration
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 44
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: marginal adaptation
timeFrame: 2 weeks-12 months
measure: marginal discoloration
timeFrame: 2 weeks-12 months
measure: color match
timeFrame: 2 weeks-12 months
measure: surface texture
timeFrame: 2 weeks-12 months
measure: secondary caries
timeFrame: 2 weeks-12 months
measure: postoperative sensitivity
timeFrame: 2 weeks-12 months
measure: retention
timeFrame: 2 weeks-12 months
Secondary outcomes:
measure: anatomic form
timeFrame: 2 weeks-12 months
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Merve Abakli Inci
Study officials:
References: