Comparison of the 2-year Clinical Performances of Class II Restorations Using Different Restorative Materials

NCT06562868 | Completed

• 1 other identifier: ERU-RDT-SHS-01
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the clinical success of different filling materials used in the treatment of dental caries. Systemically healthy individuals with good oral hygiene and interproximal caries in their posterior teeth participated in the study. Participants underwent initial radiographic and intraoral examinations. Three different filling materials were applied to the participants' teeth. The restorations were evaluated at baseline, 1 year, and 2 years.

Conditions

Dental Caries Class II

Outcome Measures

Primary Outcomes (1)

• FDI World Dental Federation Evaluation Criteria

  The FDI evaluation criteria, developed by the World Dental Federation, are used to assess the clinical performance of dental restorations. The restorations were evaluated separately for each criterion and scored on a scale from 1 to 5: 1 = clinically excellent, 2 = clinically good, 3 = clinically adequate, 4 = clinically insufficient (requires repair), 5 = clinically poor (requires replacement).

  two years

Study Arms (3)

Bulk-fill Composite Resin

ACTIVE COMPARATOR

Before starting the restoration procedure, local anesthesia was administered to the tooth or teeth. The caries were removed and the preparation was completed. Following the washing and drying of the cavities, cotton rolls and saliva ejectors were placed to ensure isolation. An appropriate matrix system and wooden wedges were applied. A 0.2% chlorhexidine gluconate solution was used as the cavity disinfectant. Subsequently, the enamel surfaces of the teeth were roughened for 30 seconds using a selective etching technique with 37% phosphoric acid. The universal dental adhesive system was applied according to the manufacturer's instructions. Restorations were performed with Filtek One Bulk Fill Restorative , ensuring that each layer did not exceed 4 mm in thickness.The restorations were evaluated according to FDI criteria at baseline, 1 year and 2 years.

Other: Bulk-fill Composite Resin

Traditional Posterior Composite Resin

ACTIVE COMPARATOR

Before starting the restoration procedure, local anesthesia was administered to the tooth or teeth. The caries were removed and the preparation was completed. Following the washing and drying of the cavities, cotton rolls and saliva ejectors were placed to ensure isolation. An appropriate matrix system and wooden wedges were applied. A 0.2% chlorhexidine gluconate solution was used as the cavity disinfectant. Subsequently, the enamel surfaces of the teeth were roughened for 30 seconds using a selective etching technique with 37% phosphoric acid. The universal dental adhesive system was applied according to the manufacturer's instructions. Restorations were performed with Clearfil Majesty Posterior.The restorations were evaluated according to FDI criteria at baseline, 1 year and 2 years.

Other: Traditional Posterior Composite Resin

High-filler Flowable Composite Resin

ACTIVE COMPARATOR

Before starting the restoration procedure, local anesthesia was administered to the tooth or teeth. The caries were removed and the preparation was completed. Following the washing and drying of the cavities, cotton rolls and saliva ejectors were placed to ensure isolation. An appropriate matrix system and wooden wedges were applied. A 0.2% chlorhexidine gluconate solution was used as the cavity disinfectant. Subsequently, the enamel surfaces of the teeth were roughened for 30 seconds using a selective etching technique with 37% phosphoric acid. The universal dental adhesive system was applied according to the manufacturer's instructions. Restorations were performed with high-filler flowable composite resin.The restorations were evaluated according to FDI criteria at baseline, 1 year and 2 years.

Other: High-filler Flowable Composite

Interventions

Bulk-fill Composite Resin OTHER

The evaluation of the restorative material according to FDI criteria at baseline, 1 year and 2 years after application

Bulk-fill Composite Resin

Traditional Posterior Composite Resin OTHER

The evaluation of the restorative material according to FDI criteria at baseline, 1 year and 2 years after application

Traditional Posterior Composite Resin

High-filler Flowable Composite OTHER

The evaluation of the restorative material according to FDI criteria at baseline, 1 year and 2 years after application

High-filler Flowable Composite Resin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has no systemic disease
• The patient should be over 18 years of age
• The patient should have good periodontal status
• Teeth to be restored should be symptomless and vital
• Teeth to be restored should have proximal contacts on both mesial and distal surfaces and be in occlusion with the antagonist teeth
• Teeth that have class II caries lesion in external and middle 1/3 of dentine thickness radiographically

You may not qualify if:

• Xerostomia and bruxism
• Absence of adjacent and antagonist teeth
• Extremely poor oral hygiene, severe or chronic periodontitis
• Pregnant or lactating women
• Teeth that have any restoration, endodontic treatment, periodontal and periapical pathology.
• The patients who are undergoing orthodontic treatment

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University Faculty of Dentistry Department of Restorative Dentistry

Kayseri, Melikgazi, 38039, Turkey (Türkiye)

Location

Study Officials

• Sevim Hancer Sarica, RA

  Erciyes University Faculty of Dentistry Depertmant of Restorative Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: While the materials used for the restorations were known to the practitioner, neither the patients nor the specialist dentists conducting the follow-up examinations were aware of them.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Three groups with different restoration materials

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: August 20, 2024
• Study Start: October 18, 2021
• Primary Completion: June 9, 2022
• Study Completion: June 9, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)