Clinical Success of Single-Color Universal Resin Composites

NCT ID: NCT06563128

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-19
• Study Completion Date: 2025-11-27

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.

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.

Conditions

Dental Caries Class II

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Clearfil Majesty Posterior

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

Group Type: PLACEBO_COMPARATOR

Clearfil Majesty Posterior

Intervention Type: OTHER

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

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

Group Type: EXPERIMENTAL

Omnichroma Universal Group

Intervention Type: OTHER

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

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

Group Type: EXPERIMENTAL

Zen Universal Group

Intervention Type: OTHER

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

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

Group Type: EXPERIMENTAL

Vittra Aps Unique Universal Group

Intervention Type: OTHER

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

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

Group Type: EXPERIMENTAL

Charisma Diamond Universal Group

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ataturk University

OTHER

Sponsor Role: lead

Responsible Party

Mustafa Cadirci

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mustafa Çadırcı

Role: STUDY_DIRECTOR

Atatürk University Faculty of Dentistry Research Assistant

Locations

Ataturk University Faculty of Dentistry Department of Restorative Dentistry Clinic

Erzurum, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

TDH-2023-13250

Identifier Type: -

Identifier Source: org_study_id