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Clinical Trials in Turkey / NCT06563128
Active, not recruiting Not applicable

Clinical Success of Single-Color Universal Resin Composites

NCT06563128 · tracked via the Priya Life Science Turkey tracker
Sponsor
Ataturk University
Phase
Not applicable
Started
2024-08-19
Last updated
2025-09-04

Condition(s) studied

Dental Caries Class II

Investigational drug(s) / intervention(s)

Clearfil Majesty PosteriorOmnichroma Universal GroupZen Universal GroupVittra Aps Unique Universal GroupCharisma Diamond Universal Group

Clearfil Majesty Posterior: After filling the teeth of the patients with 4 different universal resins and 1 conventional composite resin, the filling will be evaluated and recorded according to the clinical success criteria at the beginning. Then, the patients will be called back to the clinic after 6 months and 12 months, respectively, and the fillings made according to the same criteria will be re-evaluated and recorded.

Omnichroma Universal Group: After filling the teeth of the patients with 4 different universal resins and 1 conventional composite resin, the filling will be evaluated and recorded according to the clinical success criteria at the beginning. Then, the patients will be called back to the clinic after 6 months and 12 months, respectively, and the fillings made according to the same criteria will be re-evaluated and recorded.

Zen Universal Group: After filling the teeth of the patients with 4 different universal resins and 1 conventional composite resin, the filling will be evaluated and recorded according to the clinical success criteria at the beginning. Then, the patients will be called back to the clinic after 6 months and 12 months, respectively, and the fillings made according to the same criteria will be re-evaluated and recorded.

Vittra Aps Unique Universal Group: After filling the teeth of the patients with 4 different universal resins and 1 conventional composite resin, the filling will be evaluated and recorded according to the clinical success criteria at the beginning. Then, the patients will be called back to the clinic after 6 months and 12 months, respectively, and the fillings made according to the same criteria will be re-evaluated and recorded.

Charisma Diamond Universal Group: After filling the teeth of the patients with 4 different universal resins and 1 conventional composite resin, the filling will be evaluated and recorded according to the clinical success criteria at the beginning. Then, the patients will be called back to the clinic after 6 months and 12 months, respectively, and the fillings made according to the same criteria will be re-evaluated and recorded.

Study summary

According to FDI criteria, the success of 4 different universal resin composites was targeted. In our study, a total of 180 teeth will be restored in class 2 cavities with 5 different composite resins in 5 groups.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * The patient should not have any systemic disease. * You must be 18 years of age or older. * The patient must have good periodontal health. * Must have acceptable oral hygiene. * The teeth to be restored must be symptom-free and vital. * The mesial and distal surfaces of the teeth to be restored must be in contact with the proximal teeth. * The tooth to be restored must be in occlusion with its antagonist. * The tooth to be restored must have a class 2 caries lesion radiographically not exceeding 2/3 of the dentin. * Patients with caries have an ICDAS 3-4 score. * Voluntary acceptance to participate in the study after being informed about the study. Exclusion Criteria: * The patient has any systemic disease. * Previously adhered restoration and endodontic treatment on the tooth to be restored. * Poor periodontal health of the patient. * Poor oral hygiene. * The patient is pregnant or breastfeeding. * The patient is undergoing orthodontic treatment. * The patient has bruxism (tooth clenching) and a dry mouth. * The teeth are devitalised. * The patient refused to participate in the study after being informed about the study.

Primary outcome measure(s)

  • Group 1: Omnichroma (Tokuyama Dental) Universal Composite — Baseline, 6th month and 12th month
    Restorations will be assessed at baseline, 6 months, and 12 months by two pre-calibrated and experienced dentists who are blinded to the restorative material used. The evaluations will be performed according to FDI and modified USPHS criteria. In cases of discrepancies between the assessors, the restorations will be re-evaluated by both assessors, and a final consensus will be reache.
  • Group 2: Vittra APS Unique (FGM) Universal Composite — Baseline, 6th month and 12th month
    Restorations will be assessed at baseline, 6 months, and 12 months by two pre-calibrated and experienced dentists who are blinded to the restorative material used. The evaluations will be performed according to FDI and modified USPHS criteria. In cases of discrepancies between the assessors, the restorations will be re-evaluated by both assessors, and a final consensus will be reache.
  • Group 3: Zen Chroma (President Dental) Universal Composite — Baseline, 6th month and 12th month
    Restorations will be assessed at baseline, 6 months, and 12 months by two pre-calibrated and experienced dentists who are blinded to the restorative material used. The evaluations will be performed according to FDI and modified USPHS criteria. In cases of discrepancies between the assessors, the restorations will be re-evaluated by both assessors, and a final consensus will be reache.
  • Group 4: Charisma Diamond (Kulzer) Universal Composite — Baseline, 6th month and 12th month
    Restorations will be assessed at baseline, 6 months, and 12 months by two pre-calibrated and experienced dentists who are blinded to the restorative material used. The evaluations will be performed according to FDI and modified USPHS criteria. In cases of discrepancies between the assessors, the restorations will be re-evaluated by both assessors, and a final consensus will be reache.
  • Group 5: Clearfill Majesty Posterior (Kuraray) Dental Composite — Baseline, 6th month and 12th month
    Restorations will be assessed at baseline, 6 months, and 12 months by two pre-calibrated and experienced dentists who are blinded to the restorative material used. The evaluations will be performed according to FDI and modified USPHS criteria. In cases of discrepancies between the assessors, the restorations will be re-evaluated by both assessors, and a final consensus will be reache.

Trial sites (1)

FacilityCityRegionStatus
Ataturk University Faculty of Dentistry Department of Restorative Dentistry Clinic Erzurum Turkey (Türkiye)

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06563128 on ClinicalTrials.gov ↗ ← All trials in Turkey