Partial Caries Removal in Permanent Molars Restored Using Giomer

NewGiza University

Status: Not yet enrolling

Conditions: Caries, Dental

Treatments: Procedure: Beautifil II LS (Low-Shrinkage); Procedure: Nanohybrid resin composite

Study type: Interventional

Funder types: Other

Identifiers

NCT06601972

giomervscomp

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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

2. 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

1. Exclusion criteria of participants:

   • known allergic reaction to resinous materials.
   • Systemic disease or severe medical complications.
   • Periodontal problem.
   • Bruxism
   • Poor oral hygiene

2. Exclusion criteria of teeth:

   • Class II caries lesion
   • Shallow or enamel caries
   • Teeth with periapical lesions.
   • Mobile teeth, arrest caries and non-vital teeth

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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122 participants in 2 patient groups

Giomer

Experimental group

Description:

Low-shrinkage bioactive material

Treatment:

Procedure: Beautifil II LS (Low-Shrinkage)

Nanohybrid composite

Active Comparator group

Description:

Universal Nano-hybrid composite

Treatment:

Procedure: Nanohybrid resin composite