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Active, not recruitingNCT06563128Updated Sep 4, 2025

Clinical Success of Single-Color Universal Resin Composites

An interventional study of Clearfil Majesty Posterior and Omnichroma Universal Group in Dental Caries Class II, sponsored by Ataturk University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-04.

Sponsored by Ataturk University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

Read the detailed description

The study will be conducted in the clinic of the Atatürk University Faculty of Dentistry, Department of Restorative Dental Treatment. After the participants fulfil the inclusion criteria, no interventional procedures other than the treatments routinely applied in the clinic will be performed. Participants who apply to the clinic with the need for dental caries treatment will be included in the study if they accept it. Before the treatment, anamnesis will be taken from the participants, and their information (age, gender) will be recorded. If necessary, local anaesthesia will be applied before or after opening the cavity. If anaesthesia is applied, they will be asked whether they feel numbness. In the study, a total of 180 teeth in 5 groups will be restored with 5 different composite resins.

Group 1: Omnichroma Group 2: Vittra Aps Unique Group 3: OneShade Group 4: Charisma Diamond Group 5: Clearfil Majesty Posterior

Then, the cavity will be prepared by using diamond rond and steel rond drills in class 2 cavity preparation. After the enamel surfaces of the teeth are roughened and washed with 37% orthophosphoric acid for 30 seconds, the necessary isolation will be provided with cotton pellets and saliva absorbent. Teeth will be fixed with matrix band and wedge systems. The adhesive bond system will be applied to all surfaces of the cavity with a bonding brush according to the manufacturer's instructions. Air will be gently applied to the cavity surface to create a shiny surface with an air gun. It will then be polymerised with an LED light device. Next, five different resin composites will be placed in the respective cavities and polymerised again with the light device. Finishing operations will be performed with a diamond-lobed milling cutter, and polishing operations will be performed with rubber systems. To evaluate the clinical success of the restorations, participants will be called at 1 week (baseline), 6 months, and 1 year to be evaluated by two specialists using FDI criteria and the results will be recorded.

02

Conditions studied

  • Dental Caries Class II
03

In context

Lead sponsor

Ataturk University is the lead sponsor of 442 studies on the registry; 121 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
45 participants (estimated)

Study arms

  • Placebo comparator
    Clearfil Majesty Posterior

    It is a type of composite used in the back group of teeth. It was used for the control group.

    Other: Clearfil Majesty Posterior

  • Experimental
    Omnichroma Universal Group

    It is a single-color universal resin composite used in both anterior and posterior group teeth.

    Other: Omnichroma Universal Group

  • Experimental
    Zen Universal Group

    It is a single-color universal resin composite used in both anterior and posterior group teeth.

    Other: Zen Universal Group

  • Experimental
    Vittra Aps Unique Universal Group

    It is a single-color universal resin composite used in both anterior and posterior group teeth.

    Other: Vittra Aps Unique Universal Group

  • Experimental
    Charisma Diamond Universal Group

    It is a single-color universal resin composite used in both anterior and posterior group teeth.

    Other: Charisma Diamond Universal Group

Interventions

  • OtherClearfil 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.

  • OtherOmnichroma 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.

  • OtherZen 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.

  • OtherVittra 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.

  • OtherCharisma 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.

06

What researchers measure

Primary outcomes

  1. Group 1: Omnichroma (Tokuyama Dental) Universal Composite

    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.

    Time frame: Baseline, 6th month and 12th month

  2. Group 2: Vittra APS Unique (FGM) Universal Composite

    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.

    Time frame: Baseline, 6th month and 12th month

  3. Group 3: Zen Chroma (President Dental) Universal Composite

    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.

    Time frame: Baseline, 6th month and 12th month

  4. Group 4: Charisma Diamond (Kulzer) Universal Composite

    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.

    Time frame: Baseline, 6th month and 12th month

  5. Group 5: Clearfill Majesty Posterior (Kuraray) Dental Composite

    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.

    Time frame: Baseline, 6th month and 12th month

07

Study locations

1 site
  • Ataturk University Faculty of Dentistry Department of Restorative Dentistry Clinic
    Erzurum, 25050, Turkey (Türkiye)
08

References and documents

Publications

  • Cadirci M, Ozakar N. Clinical performance of single shade universal resin composites: a randomized controlled one year follow-up study. BMC Oral Health. 2025 Dec 18;26(1):154. doi: 10.1186/s12903-025-07472-3. PubMed 41413535 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06563128
Lead sponsor
Ataturk University
Responsible party
Mustafa Cadirci (Research Assistant, Ataturk University) — Principal investigator
First posted
Aug 20, 2024
Start date
Aug 19, 2024
Primary completion
Aug 27, 2025
Completion
Nov 27, 2025 (estimated)
Last update
Sep 4, 2025

Study contacts

Mustafa Çadırcı
study director · Atatürk University Faculty of Dentistry Research Assistant

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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