Clinical Evaluation of Direct and Indirect Composites

NCT06667271 | Completed

• 1 other identifier: RTEUDHFMKARADAS004
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Caries

Keywords

Dental caries; Restorative material; Composite resin; Indirect restorarion

Outcome Measures

Primary Outcomes (1)

• World Dental Federation criteria (FDI)

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

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Recep Tayyip Erdogan University: lead

Study Sites (1)

53020

Rize, Central, 53020, Turkey (Türkiye)

Location

Related Publications (1)

• Incekara MS, Karadas M. Clinical comparison of direct and indirect class II composite restorations: a prospective 12-month follow-up study. BMC Oral Health. 2025 Jul 19;25(1):1217. doi: 10.1186/s12903-025-06604-z.

  PMID: 40684149 DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 31, 2024
• Study Start: March 16, 2023
• Primary Completion: August 16, 2024
• Study Completion: November 1, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)