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

• Sponsor: Necmettin Erbakan University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05551130
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 2
• Actual Duration (Months): 12
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Restoration Failure of Marginal Integrity	Other: Restoration	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 1, 2020
• Actual Primary Completion Date: Aug 16, 2020
• Actual Study Completion Date: Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Equia Group Equia system bulk fill glass hybrid material	Other: Restoration; Restorations completed with these materials.; Other Names: Restorative Interventions
Active Comparator: Charisma Group Charisma Smart universal composite resin	Other: Restoration; Restorations completed with these materials.; Other Names: Restorative Interventions

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Merve Abakli Inci	Konya		Turkey	42090

Sponsors and Collaborators

• Necmettin Erbakan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hazal Özer, Assist. Prof., Necmettin Erbakan University
• ClinicalTrials.gov Identifier: NCT05551130
• Other Study ID Numbers: 2020/332
• First Posted: Sep 22, 2022
• Last Update Posted: Sep 26, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hazal Özer, Assist. Prof., Necmettin Erbakan University: Composite Resins; Clinical Trial; Glass Ionomer Cements; Permanent Dental Restoration

Study Results

No Results Posted as of Sep 26, 2022