NCT06563128

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

August 19, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2025

Completed
Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

August 17, 2024

Last Update Submit

August 27, 2025

Conditions

Dental Caries Class II

Outcome Measures

Primary Outcomes (5)

  • 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.

    Baseline, 6th month and 12th month

  • 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.

    Baseline, 6th month and 12th month

  • 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.

    Baseline, 6th month and 12th month

  • 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.

    Baseline, 6th month and 12th month

  • 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.

    Baseline, 6th month and 12th month

Study Arms (5)

Clearfil Majesty Posterior

PLACEBO COMPARATOR

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

Other: Clearfil Majesty Posterior

Omnichroma Universal Group

EXPERIMENTAL

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

Other: Omnichroma Universal Group

Zen Universal Group

EXPERIMENTAL

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

Other: Zen Universal Group

Vittra Aps Unique Universal Group

EXPERIMENTAL

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

Other: Vittra Aps Unique Universal Group

Charisma Diamond Universal Group

EXPERIMENTAL

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

Other: Charisma Diamond Universal Group

Interventions

Clearfil Majesty PosteriorOTHER

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.

Clearfil Majesty Posterior
Omnichroma Universal GroupOTHER

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
Zen Universal GroupOTHER

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
Vittra Aps Unique Universal GroupOTHER

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
Charisma Diamond Universal GroupOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University Faculty of Dentistry Department of Restorative Dentistry Clinic

Erzurum, 25050, Turkey (Türkiye)

Location

Study Officials

  • Mustafa Çadırcı

    Atatürk University Faculty of Dentistry Research Assistant

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Five groups with a control goup
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

August 17, 2024

First Posted

August 20, 2024

Study Start

August 19, 2024

Primary Completion

August 27, 2025

Study Completion

November 27, 2025

Last Updated

September 4, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)