Partial Caries Removal in Permanent Molars Restored Using Giomer

Official 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)

Overview

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.

Detailed description

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.

Interventions

• Procedure Beautifil II LS (Low-Shrinkage)
  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
• Procedure Nanohybrid resin composite
  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 outcome measures

• Success rate [Time frame: From enrollment to the end of treatment at 24 months]

Secondary outcome measures (1)

• Dentin bridge formation [Time frame: From enrollment to the end of treatment at 24 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06601972 · giomervscomp

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗