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

NCT07806578 | Completed

• 1 other identifier: TDK-2022-10196
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Caries

Keywords

Resin Composite; Injectable Resin Composite; Conventional Resin Composite; Posterior Restoration; Class I Restoration; FDI Criteria; Split-Mouth Design; Scanning Electron Microscopy

Outcome Measures

Primary Outcomes (1)

• Clinical Performance of Restorations Assessed Using FDI Criteria

  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.

  One week, six months, and 12 months after restoration placement

Secondary Outcomes (1)

• Micromorphological Findings Assessed by Scanning Electron Microscopy

  One week, six months, and 12 months after restoration placement

Study Arms (2)

Injectable Resin Composite

EXPERIMENTAL

Eligible posterior Class I cavities allocated to this arm were restored with G-ænial Universal Injectable, a highly filled injectable resin composite. The material was placed in 1-mm increments, and each increment was light-polymerized for 20 seconds. Each participant received this material in at least one eligible tooth as part of the split-mouth design.

Device: G-ænial Universal Injectable

Conventional Resin Composite

ACTIVE COMPARATOR

Eligible posterior Class I cavities allocated to this arm were restored with G-ænial Posterior, a conventional resin composite. The material was placed in increments no thicker than 2 mm, and each increment was light-polymerized for 20 seconds. Each participant received this material in at least one eligible tooth as part of the split-mouth design.

Device: G-ænial Posterior

Interventions

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.

Injectable Resin Composite

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.

Conventional Resin Composite

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yüzüncü Yıl University Faculty of Dentistry

Van, 65080, Turkey (Türkiye)

Location

Related Links

• Related Info

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Alperen Değirmenci, DDS, PhD

  Department of Restorative Dentistry, Faculty of Dentistry, Van Yüzüncü Yıl University, Van, Türkiye.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants were not informed which restorative material was used in each tooth. The outcomes assessor who performed the FDI evaluations was not involved in the restorative procedures and was blinded to the material allocation and the restorative material used in each tooth. The clinician who placed the restorations could not be blinded because the materials had different handling characteristics. The examiner performing the micromorphological assessment was blinded to the clinical evaluation results.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, PhD

Model Details: This study used a randomized split-mouth design. Each participant received both restorative materials in different eligible posterior teeth and therefore served as their own control. The two interventions were applied concurrently to different restoration sites and were followed for one year.

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 8, 2026
• Study Start: April 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: May 1, 2023
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: De-identified individual participant data and the selected supporting information will be available beginning three months after publication of the study results and will remain available for five years.
• Access Criteria: Qualified researchers may access the data by submitting a methodologically sound research proposal to the corresponding author. We will evaluate requests based on the proposed scientific purpose, ethical requirements, participant confidentiality, and institutional policies. We will share only de-identified data relevant to the approved proposal. Ethics approval and a signed data use agreement may be required before granting access.

Locations

TU (1)