Clinical Evaluation of Class I Direct and Indirect Restorations Over 10 Years

Kocaeli University

Status: Completed

Conditions: Dental Caries; Clinical Trial

Treatments: Device: Direct Restoration with Microhybrid Composite; Device: Indirect Restoration with Reinforced Microfill Composite

Study type: Interventional

Funder types: Other

Identifiers

NCT07081529

2014/157

Details and patient eligibility

About

This clinical study aims to evaluate and compare the long-term clinical performance of direct and indirect restorations in Class I cavities of molar teeth over a 10-year period. A total of 54 restorations (27 direct and 27 indirect) were placed in 27 patients, with each patient receiving one direct and one indirect restoration. The restorations were evaluated at baseline, and at 1-, 2-, and 10-year follow-ups using modified USPHS criteria.

Full description

This prospective clinical study was designed to evaluate and compare the long-term clinical performance of direct and indirect composite restorations in Class I cavities of permanent molar teeth over a 10-year period.

A total of 27 patients were enrolled in the study. Each participant received one direct and one indirect restoration, resulting in a total of 54 restorations (27 direct and 27 indirect).

Direct restorations were performed intraorally using a microhybrid composite and adhesive system in accordance with the manufacturer's instructions. Indirect restorations were fabricated in the laboratory using a reinforced microfill composite system and cemented using resin cement.

All restorations were clinically evaluated at baseline, and at 1-, 2-, and 10-year follow-up appointments. The modified United States Public Health Service (USPHS) criteria were used for evaluation. The assessed parameters included surface texture, anatomic form, color match, marginal adaptation, cavosurface marginal discoloration, and the presence of caries.

The aim of this study is to provide evidence-based clinical data regarding the durability and performance of direct and indirect composite restorations in posterior teeth.

Enrollment: 27 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients presenting with two Class I cavities
• Good oral hygiene maintenance
• Absence of pulp or periodontal disease
• Requirement for restoration of permanent molars due to occlusal caries

Exclusion criteria

• Presence of parafunctional habits (e.g., bruxism or clenching)
• Poor oral hygiene
• Lack of interest in or refusal to comply with oral hygiene instructions
• Pulp exposure during caries removal
• Percussion sensitivity indicating possible pulpal or periapical pathology
• Spontaneous discomfort associated with periodontal disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Direct and Indirect Restorations

Experimental group

Description:

Participants in this arm received two different types of restorations in Class I cavities of molar teeth: one direct restoration using a microhybrid universal composite, and one indirect restoration using a reinforced microfill composite system. Each patient received one of each restoration type on different molar teeth. Clinical evaluations were conducted at baseline, 1 year, 2 years, and 10 years using modified USPHS criteria.

Treatment:

Device: Indirect Restoration with Reinforced Microfill Composite

Device: Direct Restoration with Microhybrid Composite