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

Not Applicable

Completed

• Conditions: Clinical Trial; Dental Caries

• Registration Number: NCT07081529
• Lead Sponsor: Kocaeli University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2014-06-01
• Primary Completion: 2014-10
• Study Completion: 2024-06-01
• Status Verified: 2025-07
• Study First Submitted: 2025-07-10
• Study First Submitted QC: 2025-07-22
• Last Update Submitted: 2025-07-22
• Study First Posted: 2025-07-23
• Last Update Posted: 2025-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
10-Year Clinical Success Rate of Direct and Indirect Restorations	10 years	The primary outcome is the clinical success rate of direct and indirect Class I restorations in molar teeth after 10 years. Success and failure were assessed using modified United States Public Health Service (USPHS) criteria. A restoration was considered a failure if it required replacement due to secondary caries or other clinical complications.