Clinical Success of Single-Color Universal Resin Composites

Evaluation of the Clinical Success of Single Colour Universal Resin Composites

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dental Caries Class II
• Intervention / Treatment: Other: Clearfil Majesty Posterior; Other: Omnichroma Universal Group; Other: Zen Universal Group; Other: Vittra Aps Unique Universal Group; Other: Charisma Diamond Universal Group

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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
Experimental: Omnichroma Universal Group; It is a single-color universal resin composite used in both anterior and posterior group teeth.	Other: 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.
Experimental: Zen Universal Group; It is a single-color universal resin composite used in both anterior and posterior group teeth.	Other: 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.
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ataturk University
• Investigators: Study Director: Mustafa Çadırcı, Atatürk University Faculty of Dentistry Research Assistant

Publications and helpful links

General Publications

• Hickel R, Roulet JF, Bayne S, Heintze SD, Mjor IA, Peters M, Rousson V, Randall R, Schmalz G, Tyas M, Vanherle G. Recommendations for conducting controlled clinical studies of dental restorative materials. Science Committee Project 2/98--FDI World Dental Federation study design (Part I) and criteria for evaluation (Part II) of direct and indirect restorations including onlays and partial crowns. J Adhes Dent. 2007;9 Suppl 1:121-47. Erratum In: J Adhes Dent. 2007 Dec;9(6):546.
• Pereira Sanchez N, Powers JM, Paravina RD. Instrumental and visual evaluation of the color adjustment potential of resin composites. J Esthet Restor Dent. 2019 Sep;31(5):465-470. doi: 10.1111/jerd.12488. Epub 2019 May 16.
• Ferracane JL. Current trends in dental composites. Crit Rev Oral Biol Med. 1995;6(4):302-18. doi: 10.1177/10454411950060040301.
• Baldissera RA, Correa MB, Schuch HS, Collares K, Nascimento GG, Jardim PS, Moraes RR, Opdam NJ, Demarco FF. Are there universal restorative composites for anterior and posterior teeth? J Dent. 2013 Nov;41(11):1027-35. doi: 10.1016/j.jdent.2013.08.016. Epub 2013 Aug 31.
• Ebaya MM, Ali AI, El-Haliem HA, Mahmoud SH. Color stability and surface roughness of ormocer- versus methacrylate-based single shade composite in anterior restoration. BMC Oral Health. 2022 Sep 27;22(1):430. doi: 10.1186/s12903-022-02423-8.
• Demarco FF, Collares K, Correa MB, Cenci MS, Moraes RR, Opdam NJ. Should my composite restorations last forever? Why are they failing? Braz Oral Res. 2017 Aug 28;31(suppl 1):e56. doi: 10.1590/1807-3107BOR-2017.vol31.0056.
• Demarco FF, Cenci MS, Montagner AF, de Lima VP, Correa MB, Moraes RR, Opdam NJM. Longevity of composite restorations is definitely not only about materials. Dent Mater. 2023 Jan;39(1):1-12. doi: 10.1016/j.dental.2022.11.009. Epub 2022 Dec 7.

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2024
• Primary Completion (Actual): August 27, 2025
• Study Completion (Estimated): November 27, 2025

Study Registration Dates

• First Submitted: August 17, 2024
• First Submitted That Met QC Criteria: August 17, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 27, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries
• Other Study ID Numbers: TDH-2023-13250

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No