Partial Caries Removal in Permanent Molars Restored Using Giomer

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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Caries, Dental
• Intervention / Treatment: Procedure: Beautifil II LS (Low-Shrinkage); Procedure: Nanohybrid resin composite

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 Type: Interventional
• Enrollment (Estimated): 122
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Omar O Shaalan, PhD; Phone Number: +201122665661; Email: omar.shaalan@ngu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Giomer; Low-shrinkage bioactive material	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
Active Comparator: Nanohybrid composite; Universal Nano-hybrid composite	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate	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.	From enrollment to the end of treatment at 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dentin bridge formation	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)	From enrollment to the end of treatment at 24 months

Collaborators and Investigators

• Sponsor: NewGiza University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 16, 2024
• First Submitted That Met QC Criteria: September 16, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 16, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: giomer; bioactive; partial caries removal
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: giomervscomp

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: confidentiality, risk of data misinterpretation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No