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Completed

NCT Number: NCT05551130

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

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.

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Key information

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Merve Abakli Inci

Konya, 42090, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Restoration

Other

Restorations completed with these materials.

Other names: Restorative Interventions

Primary outcomes

  1. marginal adaptation

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. anatomic form

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Sep 22, 2022
Registry last updated
Sep 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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