Skip to main content
OpenTrials
Completed

NCT Number: NCT07806578

Clinical Performance of Injectable and Conventional Resin Composites in Posterior Class I Restorations

This study compared the one-year clinical performance of two tooth-colored filling materials used for restoring cavities in posterior teeth: a highly filled injectable resin composite and a conventional resin composite. The study included 38 participants aged 20 to 26 years who required at least two Class I restorations in permanent premolars or molars. Each participant received both restorative materials in different teeth using a randomized split-mouth design. A total of 120 restorations were placed, including 60 restorations with G-ænial Universal Injectable and 60 restorations with G-ænial Posterior. The restorations were evaluated one week, six months, and 12 months after placement using the FDI criteria, which assess esthetic, functional, and biological properties. In addition, 20 participants with 64 restorations were randomly selected for a detailed assessment of restoration surfaces and margins. Digital impressions were obtained, three-dimensional resin replicas were produced, and the replicas were examined using scanning electron microscopy. The study aimed to determine whether the two restorative materials differed in their clinical and micromorphological performance during the one-year follow-up period.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Van Yüzüncü Yıl University Faculty of Dentistry

Van, 65080, Turkey (Türkiye)

About this study

This was a prospective, randomized, assessor-blinded, split-mouth clinical trial conducted at the Department of Restorative Dentistry, Faculty of Dentistry, Van Yüzüncü Yıl University. Systemically healthy individuals with good oral hygiene and at least two carious lesions classified as International Caries Detection and Assessment System scores 4 or 5 in permanent premolars and/or molars were eligible. Individuals with bruxism, malocclusion, xerostomia, or periodontal disease were excluded. Teeth with previous restorations, endodontic treatment, periodontal or periapical pathology, or no antagonist or adjacent tooth were also excluded.

Thirty-eight participants aged 20 to 26 years were enrolled. A total of 120 posterior Class I restorations were placed. Each participant received both study materials in different eligible teeth according to a split-mouth design. The first eligible tooth and the material assigned to that tooth were determined by coin toss, and allocation of the remaining eligible teeth continued clockwise within the dental arches. G-ænial Posterior, a conventional resin composite, was used for 60 restorations, and G-ænial Universal Injectable, a highly filled injectable resin composite, was used for 60 restorations.

All restorations were placed by the same clinician using standardized cavity preparation, adhesive, light-polymerization, finishing, and polishing procedures. Participants were unaware of the material used in each tooth. Clinical assessments were performed by another investigator who was not involved in placing the restorations.

The restorations were evaluated one week, six months, and 12 months after placement using the FDI evaluation system. Esthetic, functional, and biological properties were scored from 1 to 5. Scores of 1 to 3 were considered clinically acceptable, whereas scores of 4 or 5 were considered clinically unacceptable.

Twenty participants with 64 restorations were randomly selected for micromorphological assessment. Digital impressions were obtained at one week, six months, and 12 months. Three-dimensional resin replicas were manufactured and examined by scanning electron microscopy. The visible restoration margins were assessed for marginal integrity, excess material, marginal fractures, negative marginal steps, marginal leakage, and other surface or marginal defects. The examiner performing the micromorphological assessment was blinded to the clinical evaluation results.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Systemically healthy individuals with good oral hygiene.
  • Presence of at least two carious lesions classified as International Caries
  • Detection and Assessment System (ICDAS) scores 4 or 5 in permanent premolars and/or molars.
  • Teeth suitable for direct Class I resin composite restoration.
  • Presence of an antagonist and adjacent tooth for each eligible tooth.
  • Provision of written informed consent.

Exclusion criteria

  • Bruxism.
  • Malocclusion.
  • Xerostomia.
  • Periodontal disease.
  • Previous restoration or endodontic treatment in an eligible tooth.
  • Periodontal or periapical pathology involving an eligible tooth.
  • Absence of an antagonist or adjacent tooth.

Treatment and study plan

G-ænial Universal Injectable

Device

A highly filled, light-cured injectable resin composite (shade A2; GC Corporation, Tokyo, Japan) was used for direct restoration of posterior Class I cavities. The material was applied in 1-mm increments and light-polymerized for 20 seconds per increment.

G-ænial Posterior

Device

A conventional, light-cured resin composite (shade A2; GC Corporation, Tokyo, Japan) used for direct restoration of posterior Class I cavities. The material was placed in increments no thicker than 2 mm and light-polymerized for 20 seconds per increment.

Primary outcomes

  1. Clinical Performance of Restorations Assessed Using FDI Criteria

    Time frame: One week, six months, and 12 months after restoration placement

    Restorations were evaluated using the esthetic, functional, and biological criteria of the FDI evaluation system. Esthetic criteria included surface gloss and roughness, staining, color match, translucency, and anatomical form. Functional criteria included fracture and retention, marginal adaptation, proximal contact, food impaction, radiographic appearance, and patient satisfaction. Biological criteria included postoperative sensitivity, pulp vitality, recurrent caries, tooth integrity, periodontal response, adjacent mucosa, and oral and general health. Each criterion was scored separately from 1 to 5: 1 = clinically excellent, 2 = clinically good, 3 = clinically satisfactory, 4 = clinically unsatisfactory but repairable, and 5 = clinically poor or failed. Lower scores indicated better performance. Scores 1-3 were clinically acceptable; scores 4-5 were unacceptable. Frequencies and percentages were recorded for each criterion; no total FDI score was calculated.

Secondary outcomes

  1. Micromorphological Findings Assessed by Scanning Electron Microscopy

    Time frame: One week, six months, and 12 months after restoration placement

    Three-dimensional resin replicas of the restorations were examined using scanning electron microscopy. The visible restoration margins were evaluated according to the micromorphological component of the CPM criteria for the presence of marginal integrity changes, excess material, marginal fractures, negative marginal steps, marginal leakage, and other restoration defects. Each finding was recorded as present or absent, and the number and percentage of restorations exhibiting each finding were determined separately. No overall micromorphological score was calculated.

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

Evaluation of the Clinical Performance of Conventional and Injectable Resin Composites in Posterior Class I Restorations According to FDI Criteria: A One-Year In Vivo Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

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.

Published trials that share one or more normalized conditions with this study.