Clinical trial NCT06601972: 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Caries, Dental
Keywords: partial caries removal
bioactive
giomer
Lead sponsor: NewGiza University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dental manufacturers\&#39; 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.

Eligibility criteria: 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 \&gt;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

Primary outcomes:
measure: Success rate
timeFrame: From enrollment to the end of treatment at 24 months
Secondary outcomes:
measure: Dentin bridge formation
timeFrame: From enrollment to the end of treatment at 24 months
Other outcomes:
Locations:
Study officials:
References: