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

NCT07081529 | Completed

• 1 other identifier: 2014/157
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Clinical Trial; Dental Caries

Outcome Measures

Primary Outcomes (1)

• 10-Year Clinical Success Rate of Direct and Indirect Restorations

  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.

  10 years

Study Arms (1)

Direct and Indirect Restorations

EXPERIMENTAL

Participants in this arm received two different types of restorations in Class I cavities of molar teeth: one direct restoration using a microhybrid universal composite, and one indirect restoration using a reinforced microfill composite system. Each patient received one of each restoration type on different molar teeth. Clinical evaluations were conducted at baseline, 1 year, 2 years, and 10 years using modified USPHS criteria.

Device: Direct Restoration with Microhybrid Composite; Device: Indirect Restoration with Reinforced Microfill Composite

Interventions

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.

Direct and Indirect Restorations

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.

Direct and Indirect Restorations

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kocaeli University: lead

Related Publications (1)

• Tekce N, Demirci M, Tuncer S, Oghan Turkoglu M, Turgut V, Balci SN, Yersel G. Clinical evaluation of direct and indirect restorations in class I cavities: a 10-year follow-up study. BMC Oral Health. 2025 Sep 25;25(1):1430. doi: 10.1186/s12903-025-06775-9.

  PMID: 40999454 DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Neslihan Tekçe

  Kocaeli University, Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr.

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 23, 2025
• Study Start: June 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: June 1, 2024
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share