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NCT Number: NCT06601972

Partial Caries Removal in Permanent Molars Restored Using Giomer

Dental manufacturers' constant tweaks and improvements to composite compositions have resulted in a wider spectrum of restorative materials with positive long-term clinical performance. For example, the creation of bioactive giomer material with proven continuous multi-ion release has been beneficial in avoiding demineralization and imparting acid resistance to enamel and dentin.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Giomer resin not only reduces the risk of secondary caries around restorations by releasing fluoride ions, but it also has good esthetic, physical, and handling features. Furthermore, advancements have been made to reduce giomer resin polymerization shrinkage by incorporating filler technology into the matrix system. As a result of these efforts, giomer resin is currently distinguished by its low shrinkage feature. According to the manufacturer, low shrinkage giomer resin has volumetric shrinkage of 0.8% and a polymerization shrinkage stress of 2.72 MPa. Several investigations were carried out to examine the overall clinical performance of low shrinkage giomer resin with equivalent success rates when compared to other restorative materials. The aim of the current study is to evaluate the effect of giomer in maintaining pulp health and dentin bridge formation after partial caries removal in permanent teeth with deep occlusal carious lesion when compared to resin composite restoration.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Inclusion criteria of participants:
  • 18 -35 years.
  • Not received antibiotic therapy since 1 month before sampling.
  • Males or Females (Both genders).
  • Co-operative patients approving the trial.
  • Good to fair oral hygiene
  • Inclusion criteria of teeth:
  • Class I cavitated lesions in permanent molars (reaching >1/2 of the dentin on radiographic examination)
  • Absence of spontaneous pain; negative sensitivity to percussion; and absence of periapical lesions (radiographic examination).

Exclusion criteria

  • Exclusion criteria of participants:
  • known allergic reaction to resinous materials.
  • Systemic disease or severe medical complications.
  • Periodontal problem.
  • Bruxism
  • Poor oral hygiene
  • Exclusion criteria of teeth:
  • Class II caries lesion
  • Shallow or enamel caries
  • Teeth with periapical lesions.
  • Mobile teeth, arrest caries and non-vital teeth

Treatment and study plan

Beautifil II LS (Low-Shrinkage)

Procedure

The most remarkable feature of this light-cured universal composite for anterior and posterior restorations is its unique shrinkage of 0.85 percent by volume

Nanohybrid resin composite

Procedure

Nanohybrid resin composites are the most popular, because they improve the distribution of fillers in the matrix by combining nanoparticles with submicron particles to achieve better mechanical, chemical, and optical properties

Primary outcomes

  1. Success rate

    Time frame: From enrollment to the end of treatment at 24 months

    The primary outcome of the present clinical trial is success rate, expressed as a binary variable indicating whether the restored tooth maintained its pulp vitality after 24 months. Success will be evaluated by a positive response to cold pulp testing, absence of spontaneous pain, no tenderness to percussion, absence of periapical radiolucency.

Secondary outcomes

  1. Dentin bridge formation

    Time frame: From enrollment to the end of treatment at 24 months

    Dentin bridge formation will be evaluated by digital radiographs taken with standardized exposure parameters according to standardized procedure by placement of film holders in paralleling technique. Dentin bridge formation will be measured by millimeters (mm)

Study contacts

Contact information is provided by the study sponsor or research team.

Omar O Shaalan, PhD

CONTACT

[email protected]

+201122665661

Sponsors and collaborators

Lead sponsor

NewGiza University

Other

Registry information

Official study title

Clinical and Radiographic Evaluation of Partial Caries Removal in Permanent Molars Restored Using Giomer Compared to Resin Composite Restorations After 24 Months (A Randomized Clinical Trial)

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

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.

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