Clinical Evaluation of Direct and Indirect Composites

January 6, 2026 updated by: Muhammet Karadaş, Recep Tayyip Erdogan University

Clinical Evaluation of Posterior Restorations Made With 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.

Study Overview

Status

Completed

Conditions

Detailed Description

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).

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The characteristics of the teeth were recorded prior to any restorative procedures. Periapical radiographs were used to assess the status and extent of caries, as well as to identify any potential periodontal or periapical pathologies that might necessitate endodontic treatment. The treated teeth were vital, asymptomatic, and in occlusal contact. Indirect composite restorations were applied to teeth that had caries, old composite or amalgam restorations, secondary caries, or teeth with cuspid loss where the isthmus width exceeded two-thirds of the intercuspal distance.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Recep Tayyip Erdogan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2023

Primary Completion (Actual)

August 16, 2024

Study Completion (Actual)

November 1, 2025

Study Registration Dates

First Submitted

October 29, 2024

First Submitted That Met QC Criteria

October 30, 2024

First Posted (Actual)

October 31, 2024

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTEUDHFMKARADAS004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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