Clinical Evaluation of Direct and Indirect Composites

The most commonly used materials in the treatment of decayed teeth are amalgam and composite resins. Because amalgam cannot meet the aesthetic expectations of patients and the rapidly increasing belief that it is toxic, its use has decreased considerably. Although composite resins are primarily used in anterior teeth because they provide aesthetically satisfactory results, they have also become the most preferred material in posterior teeth. This shift is largely due to the significant advancements in their mechanical properties, such as improved strength and durability. Indirect restorations have begun to be used to overcome the disadvantages of resin composites applied with the direct method. Both composite resins and ceramics have given good results for such restorations. However, composite resins have the advantage of being cheaper, more user-friendly, and repairable than ceramics. Laboratory-prepared composite inlays/onlays are more wear-resistant than direct composites, especially in occlusal contact areas. Therefore, they are generally indicated for the restoration of large cavities. Considering the material loss caused by crown restorations and the disadvantages of direct composites in the treatment of teeth with extensive caries, we aimed to treat indirect resin composites that we can apply by making more minimally invasive preparations while supporting the dental tissues.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

53020

Rize, Central, 53020, Turkey (Türkiye)

About this study

This study was a double-blind randomized controlled clinical trial involving both evaluators and patients. The research compared indirect restorations with direct restorations. Patients receiving treatment were recalled for follow-ups after one week, six months, and twelve months. Restorations were assessed clinically based on modified FDI criteria, which included marginal discoloration, color match, anatomical form, fracture and retention, marginal adaptation, contact point, postoperative sensitivity, secondary caries, and periodontal response. Qualified clinicians conducted the evaluations using a mirror and probe under reflector light. Additionally, bite-wing radiographs were obtained from patients during the 6-month and 12-month follow-ups to assess the development of secondary caries. Differences between adhesives at each time point were analyzed using Fisher's Exact test, while the effect of time on restorations was evaluated with the Wilcoxon Signed Rank test (p < 0.05).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

They have been informed about the study and have agreed to participate.
They are over 18 years old.
They do not have any systemic diseases.
They maintain good general oral health.
They are not pregnant or breastfeeding.
The relevant tooth is vital, and the decay is at least 0.5 mm away from the pulp, as confirmed by radiographic findings.
There is a tooth in contact with the relevant tooth and an antagonist tooth.
They have agreed to attend follow-up appointments.

Exclusion criteria

After being informed about the study, the participant declined to participate.
The individual is under 18 years of age.
The volunteer has a severe systemic disease.
They have active periodontal or pulp disease.
They have received endodontic treatment.
They experience bruxism.

Treatment and study plan

Primary outcomes

World Dental Federation criteria (FDI)

Time frame: 1 year

1, Clinically very good; 2, clinically good; 3, clinically sufficient; 4, clinically unsatisfactory; 5, clinically poor

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University

Other

Registry information

Official study title

Clinical Evaluation of Posterior Restorations Made With Direct and Indirect Composites

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2025
First posted: Oct 31, 2024
Registry last updated: Jan 7, 2026

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.

Published trials that share one or more normalized conditions with this study.

Completed