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Completed

NCT Number: NCT03030690

A Clinical Assessment of Glass Carbomer Cement

This study will evaluate the clinical performance of glass carbomer cement restorations in restoring proximal lesions in primary molars compared to that of resin modified glass ionomer cement and composite resin restorations. Teeth will be randomly assigned to one of the three restoration groups and the restorations will be evaluated clinically and radiographically every six months.

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Key information

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Glass Carbomer is a monomer free; carbomised nano-glass restorative cement developed from traditional glass ionomer cement (GIC) and contains nano-sized powder particles of hydroxyapatite and fluorapatite. These materials claim to have improved mechanical properties and better bonding to dentin, in addition to continues fluoride release.

The study is a randomized controlled clinical trial where teeth will be randomly assigned to one of the three restoration groups.

Following medical and dental history, bilateral bitewing radiographs will be taken for each patient to assess the presence of proximal lesions. Suitable teeth will then be randomly assigned to one of the restoration groups. A single operator using local anesthesia and rubber dam isolation will then prepare standardized Class II cavities and place the designated restorations according to the manufacturer's instructions.

The quality of the 3 types of restorations will be clinically evaluated at baseline and every six months for color match, marginal discoloration, anatomic form, marginal adaptation, and secondary caries using the criteria described by "Cvar and Ryge" (2005). The evaluation will be performed by 2 calibrated examiners.

Following placement of the restorations, bitewing radiographs will be taken to evaluate the restorations and will be repeated every six months for detection of recurrent caries.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • One proximal lesion in a primary molar.
  • Radiographic evidence of caries extending at least into the inner half of the enamel but not the inner half of dentin.
  • Proximal contact with adjacent healthy or restored teeth.
  • Occlusal contact with opposing healthy or restored teeth.
  • No indication for pulp therapy or other restorative treatment.
  • A predicted survival until exfoliation of 2 years.

Exclusion criteria

  • Radiographic evidence of caries extending into the inner half of dentin.
  • No proximal contact with adjacent healthy or restored teeth.
  • No occlusal contact with opposing healthy or restored teeth.
  • Tooth indicated for pulp therapy or other restorative treatment.
  • A predicted survival until exfoliation of less than 2 years.

Treatment and study plan

Glass Carbomer Cement

Other

Restoration of proximal lesions in primary molars using glass carbomer cement

Other names: GCP Glass Fill, Hydroxyapatite enhance glass ionomer cement

Composite resin

Other

Restoration of proximal lesions in primary molars using composite resin.

Other names: Filtek Z250

Resin Modified Glass Ionomer Cement

Other

Restoration of proximal lesions in primary molars using resin modified glass ionomer cement

Other names: GC Fuji II LC Capsule

Primary outcomes

  1. clinical success rate of glass carbomer cement in restoring proximal lesions in primary molars.

    Time frame: 2 Years

    the clinical success of glass carbomer cement in restoring proximal lesions compared to the success of resin modified glass ionomer cement and composite resin.

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Official study title

A Clinical Assessment of Class II Glass Carbomer Cement Restorations Compared to Resin Modified Glass Ionomer Cement and Composite Resin Restorations in Primary Molars.

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 25, 2017
Registry last updated
Mar 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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