Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06637605

Clinical Comparison of Restorative Materials

Composite resin materials are the first treatment choice in direct restorations due to their good mechanical properties, excellent esthetic properties, conservative preparation, and successful clinical performance. However, resin-based composite materials in deep cavities are more likely to irritate the pulp tissue due to insufficient polymerization and residual monomer release. Therefore, glass ionomer-based restorative materials can be used more successfully in deep cavities. In addition, the hardening mechanisms of high-viscosity glass ionomer cement are the same as those of conventional glass ionomer cement, and their wear resistance, surface hardness, compression, and bending strength are increased. No clinical studies evaluate the performance of different restorative materials in deep cavities. This clinical study aims to evaluate the clinical performance of high-viscosity glass ionomer, bulk-fill composite, and conventional composite in deep cavities.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

53020

Rize, 53020, Turkey (Türkiye)

About this study

This study was a double-blind (evaluator and patient) randomized controlled clinical study with three study groups with an equal allocation. Three different restorative materials were compared in deep cavities.

The treated patients were called back for controls after one week, six months, and twelve months. Restorations were evaluated clinically according to modified FDI criteria (marginal discoloration, color match, anatomical form, fracture and retention, marginal adaptation, contact point, post-operative sensitivity, secondary caries and periodontal response).

Clinical evaluation was performed by one qualified clinicians using a mirror and probe under reflector light. Bite-wing radiographs were taken from the patients who were called for controls at 6-moth and 12-month to evaluate the formation of secondary caries.

Differences between adhesives at each time period were evaluated using Fisher's Exact test. The effect of time on restorations was evaluated using 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

  • Systemically healthy patients aged 18 and over
  • Patients with good oral hygiene.
  • Vital teeth are to be included in the study.
  • The presence of an antagonist and a contact tooth for the tooth to be restored.
  • Teeth with deep caries lesions or radiographically reaching ¾ of the dentin but with a hard dentin region between the caries and the pulp according to ESE (European Society of Endodontology) criteria.

Exclusion criteria

  • Patients with a history of bruxism and periodontal disease
  • Patients under 18 years of age
  • Spontaneous pain in the tooth to be restored
  • Intense carious lesion reaching the entire thickness of the dentin according to ESE (European Society of Endodontology) criteria
  • Observation of mechanical perforation during caries cleaning
  • Patients suspected of pregnancy or pregnant

Treatment and study plan

Primary outcomes

  1. World Dental Federation criteria (FDI)

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University

Other

Registry information

Official study title

Clinical Evaluation of Different Restorative Materials in Deep Cavities

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Oct 15, 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.