Partial Caries Removal in Permanent Molars Restored Using Giomer

NCT ID: NCT06601972

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-12-01

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.

Conditions

Caries, Dental

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Giomer

Low-shrinkage bioactive material

Group Type: EXPERIMENTAL

Beautifil II LS (Low-Shrinkage)

Intervention Type: PROCEDURE

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

Nanohybrid composite

Universal Nano-hybrid composite

Group Type: ACTIVE_COMPARATOR

Nanohybrid resin composite

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

• 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

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NewGiza University

OTHER

Sponsor Role: lead

Responsible Party

Omar Shaalan

Associate professor of conservative dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Omar O Shaalan, PhD

Role: CONTACT

omar.shaalan@ngu.edu.eg

+201122665661

Other Identifiers

giomervscomp

Identifier Type: -

Identifier Source: org_study_id