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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07081529
Enrollment
27
Registered
2025-07-23
Start date
2014-06-30
Completion date
2024-06-30
Last updated
2025-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical Trial, Dental Caries

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.

Interventions

DEVICEDirect 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.

DEVICEIndirect 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.

Sponsors

Kocaeli University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
10-Year Clinical Success Rate of Direct and Indirect Restorations10 yearsThe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026