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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)

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06601972
Enrollment
122
Registered
2024-09-19
Start date
2024-10-01
Completion date
2026-12-01
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caries, Dental

Keywords

partial caries removal, bioactive, giomer

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.

Interventions

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 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

Sponsors

NewGiza University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Success rateFrom enrollment to the end of treatment at 24 monthsThe 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

MeasureTime frameDescription
Dentin bridge formationFrom enrollment to the end of treatment at 24 monthsDentin 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)

Contacts

Primary ContactOmar O Shaalan, PhD
omar.shaalan@ngu.edu.eg+201122665661

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026