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Clinical Evaluation of Esthetic Restorations Placed in Primary Molars With Composite Resin Enriched With Insoluble Anti Bacterial Nano Particles

NCT00389714 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2007-12-11

No results posted yet for this study

Summary

Composite resins are presently among the most popular esthetic restorative materials in dentistry. These materials offer excellent esthetic appearance, allow for conservative cavity preparation and are now becoming widely accepted for clinical use in primary molars 1-23. Despite the improvement of their properties, achieved with better materials and incremental placing techniques, composite resin restorations appear to have still several drawbacks: although similar to amalgam in short terms studies, they have a high long term failure rate, mainly due to discoloration, loss of retention and secondary caries3,11,19, are time-consuming and technique sensitive, lack anti-cariogenic potential and can be amenable to secondary caries at the cervical dentin margins 1, 2.

Continued interest in providing advance in restorative esthetic materials led to the development of new generations of composites. Among the newest material developed is the use of minute amount of nanoparticles which convert composites to possess permanent antibacterial properties.

It is of great interest to observe the clinical behavior of this new material when utilized in clinical practice. Thus the aims of the present in-vivo study are:

1. To evaluate the clinical and radiographic performance of the New Restorative System when placed with adhesive systems in class II restorations of primary molars.
2. To assess, by SEM, the micromorphology of the cervical, buccal and lingual margins of the proximal surfaces of the restored teeth retrieved after exfoliation or extraction.
3. To asses, by means of polarized light microscopy, the integrity of the cervical margins of the same retrieved teeth.

Conditions

  • Dental Carious
  • Dental Filling

Interventions

DEVICE

dental restoration

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • Michael Perez Davidi, DMD · Hadassah Medical Organization

  • Ana Fux, DMD · Hadassah Medical Organization

  • Mordechay Moskovitch, DMD · Hadssah Medical Orgenization

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-02-28

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00389714 on ClinicalTrials.gov