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

NCT05551130 | Completed DMC

• 1 other identifier: 2020/332
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Restoration Failure of Marginal Integrity

Keywords

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

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• anatomic form

  2 weeks-12 months

Study Arms (2)

Equia Group

ACTIVE COMPARATOR

Equia system bulk fill glass hybrid material

Other: Restoration

Charisma Group

ACTIVE COMPARATOR

Charisma Smart universal composite resin

Other: Restoration

Interventions

Restoration OTHER

Restorations completed with these materials.

Also known as: Restorative Interventions

Charisma Group; Equia Group

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Merve Abakli Inci

Konya, 42090, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 22, 2022
• Study Start: August 1, 2020
• Primary Completion: August 16, 2020
• Study Completion: August 1, 2021
• Last Updated: September 26, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)