Partial Caries Removal in Permanent Molars Restored Using Giomer

Not Applicable

Not yet recruiting

• Conditions: Caries, Dental
• Interventions: Procedure: Beautifil II LS (Low-Shrinkage); Procedure: Nanohybrid resin composite

• Registration Number: NCT06601972
• Lead Sponsor: NewGiza University

Brief Summary

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-16
• Study First Submitted QC: 2024-09-16
• Last Update Submitted: 2024-09-16
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Study Start: 2024-10-01
• Primary Completion: 2026-10-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Giomer	Beautifil II LS (Low-Shrinkage)	Low-shrinkage bioactive material
Nanohybrid composite	Nanohybrid resin composite	Universal Nano-hybrid composite

Primary Outcome Measures

Name	Time	Method
Success rate	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 Outcome Measures

Name	Time	Method
Dentin bridge formation	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)