Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Clinical Assessment of Glass Carbomer Cement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03030690
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Sumaya Nouri, King Abdulaziz University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dental Caries Class II Other: Glass Carbomer Cement Other: Composite Resin Other: Resin Modified Glass Ionomer Cement Not Applicable

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Actual Study Start Date : November 2016
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Glass Carbomer Cement
GCP Glass Fill, Glass Carbomer™Tech, Ridderkerk, Netherlands
Other: Glass Carbomer Cement
Restoration of proximal lesions in primary molars using glass carbomer cement
Other Names:
  • GCP Glass Fill
  • Hydroxyapatite enhance glass ionomer cement

Active Comparator: Resin Modified Glass Ionomer Cement
GC Fuji II LC Capsule, GC International, Tokyo, Japan
Other: Resin Modified Glass Ionomer Cement
Restoration of proximal lesions in primary molars using resin modified glass ionomer cement
Other Name: GC Fuji II LC Capsule

Active Comparator: Composite Resin
Filtek Z250, 3M ESPE, St Paul, MN, USA
Other: Composite Resin
Restoration of proximal lesions in primary molars using composite resin.
Other Name: Filtek Z250




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030690


Sponsors and Collaborators
King Abdulaziz University
Investigators
Layout table for investigator information
Study Chair: Najlaa Alamoudi, MSc, DSc King Abdulaziz University
Additional Information:
Publications:
Lucas ME, Arita K, Nishino M. Strengthening a conventional glass ionomer cement using hydroxyapatite. J Dent Res. 2001;80:711.

Layout table for additonal information
Responsible Party: Sumaya Nouri, BDS, M.Sc, King Abdulaziz University
ClinicalTrials.gov Identifier: NCT03030690    
Other Study ID Numbers: 070-16
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sumaya Nouri, King Abdulaziz University:
Proximal Dental Caries
Glass Carbomer
Hydroxyapatite Enhanced Glass Ionomer
Primary Teeth
Additional relevant MeSH terms:
Layout table for MeSH terms
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors