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

NCT ID: NCT07081529

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2024-06-30

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.

Conditions

Clinical Trial; Dental Caries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Direct and Indirect Restorations

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.

Group Type: EXPERIMENTAL

Direct Restoration with Microhybrid Composite

Intervention Type: DEVICE

Direct Class I restorations were placed in molar teeth using a microhybrid universal composite (Aelite All-Purpose Body, Bisco) and an adhesive system according to the manufacturer's instructions.

Indirect Restoration with Reinforced Microfill Composite

Intervention Type: DEVICE

Indirect Class I restorations were fabricated using a reinforced microfill composite system (Tescera Indirect Composite System Body, Bisco) in the laboratory and cemented into molar teeth using resin cement.

Interventions

Direct Restoration with Microhybrid Composite

Direct Class I restorations were placed in molar teeth using a microhybrid universal composite (Aelite All-Purpose Body, Bisco) and an adhesive system according to the manufacturer's instructions.

Intervention Type: DEVICE

Indirect Restoration with Reinforced Microfill Composite

Indirect Class I restorations were fabricated using a reinforced microfill composite system (Tescera Indirect Composite System Body, Bisco) in the laboratory and cemented into molar teeth using resin cement.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kocaeli University

OTHER

Sponsor Role: lead

Responsible Party

Neslihan Tekçe

Professor Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neslihan Tekçe

Role: PRINCIPAL_INVESTIGATOR

Kocaeli University, Faculty of Dentistry

References

Tekce N, Demirci M, Tuncer S, Oghan Turkoglu M, Turgut V, Balci SN, Yersel G. Clinical evaluation of direct and indirect restorations in class I cavities: a 10-year follow-up study. BMC Oral Health. 2025 Sep 25;25(1):1430. doi: 10.1186/s12903-025-06775-9.

Reference Type: DERIVED

PMID: 40999454 (View on PubMed)

Other Identifiers

2014/157

Identifier Type: -

Identifier Source: org_study_id