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Completed

NCT Number: NCT07081529

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Direct Restoration with Microhybrid Composite

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

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.

Primary outcomes

  1. 10-Year Clinical Success Rate of Direct and Indirect Restorations

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

Clinical Evaluation of Direct and Indirect Restorations in Class I Cavities: A 10-Year Follow-up Study

Important dates

Study start
2014
Primary completion
2014
Study completion
2024
First posted
Jul 23, 2025
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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