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Completed

NCT Number: NCT06562868

Comparison of the 2-year Clinical Performances of Class II Restorations Using Different Restorative Materials

The aim of this study is to compare the clinical success of different filling materials used in the treatment of dental caries. Systemically healthy individuals with good oral hygiene and interproximal caries in their posterior teeth participated in the study. Participants underwent initial radiographic and intraoral examinations. Three different filling materials were applied to the participants' teeth. The restorations were evaluated at baseline, 1 year, and 2 years.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University Faculty of Dentistry Department of Restorative Dentistry

Kayseri, Melikgazi, 38039, Turkey (Türkiye)

About this study

The aim of this study was to evaluate the clinical performance of Class II carious defects restored with traditional posterior composite, bulk-fill composite, and high-fill flowable composite resin according to the World Dental Federation (FDI) criteria at 12-month and 24-month intervals. In this study, 110 patients underwent initial radiographic and intraoral examinations. Radiographically, 259 teeth with interproximal caries at D1 and D2 levels were identified. All restorations in the study were performed by the same dentist. Before starting the restoration procedure, local anesthesia was administered to the tooth or teeth. The caries were removed and the preparation was completed. Following the washing and drying of the cavities, cotton rolls and saliva ejectors were placed to ensure isolation. An appropriate matrix system and wooden wedges were applied. A 0.2% chlorhexidine gluconate solution was used as the cavity disinfectant. Subsequently, the enamel surfaces of the teeth were roughened for 30 seconds using a selective etching technique with 37% phosphoric acid. The universal dental adhesive system was applied according to the manufacturer's instructions..The first group received bulk-fill composite resin (Filtek One Bulk Fill Restorative), the second group received traditional posterior composite (Clearfil Majesty Posterior ), and the third group received high-filler flowable composite resin. The same universal dental adhesive system was used for all groups. All restorations were evaluated by two experienced dentists according to the FDI evaluation criteria at baseline,1 year and 2 years. In cases where discrepancies were observed between the two examiners, the assessment was based on a consensus decision made by both dentists. Restorations were evaluated and scored separately for each criterion on a scale from 1 to 5: 1 = clinically excellent, 2 = clinically good, 3 = clinically adequate, 4 = clinically insufficient (requires repair), 5 = clinically poor (requires replacement).

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 be over 18 years of age
  • 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 lesion 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
  • Pregnant or lactating women
  • Teeth that have any restoration, endodontic treatment, periodontal and periapical pathology.
  • The patients who are undergoing orthodontic treatment

Treatment and study plan

Bulk-fill Composite Resin

Other

The evaluation of the restorative material according to FDI criteria at baseline, 1 year and 2 years after application

Traditional Posterior Composite Resin

Other

The evaluation of the restorative material according to FDI criteria at baseline, 1 year and 2 years after application

High-filler Flowable Composite

Other

The evaluation of the restorative material according to FDI criteria at baseline, 1 year and 2 years after application

Primary outcomes

  1. FDI World Dental Federation Evaluation Criteria

    Time frame: two years

    The FDI evaluation criteria, developed by the World Dental Federation, are used to assess the clinical performance of dental restorations. The restorations were evaluated separately for each criterion and scored on a scale from 1 to 5: 1 = clinically excellent, 2 = clinically good, 3 = clinically adequate, 4 = clinically insufficient (requires repair), 5 = clinically poor (requires replacement).

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Aug 20, 2024
Registry last updated
Aug 20, 2024

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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