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Trial record 59 of 1201 for:    tooth decay

Clinical Evaluation of Nanoionomer Filling in Primary Teeth (CENFPT)

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ClinicalTrials.gov Identifier: NCT02093091
Recruitment Status : Completed
First Posted : March 20, 2014
Last Update Posted : March 20, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Sahar E. Abo-Hamar, Tanta University

Brief Summary:
This clinical trial was performed to evaluate the nano-filled resin modified glass ionomer (RMGI) -with a brand name of "Ketac Nano"- as a filling material for the treatment of caries in primary teeth. Children aged 5-8 years were selected and treated with either Ketac Nano or another conventional RMGI called Vitremer. Then, the treated children were evaluated at baseline, after one yeat and after two years. The hypothesis to be tested in the present study was: The clinical performance of nano-filled RMGI (Ketac Nano) in class I primary molars will differ from that of its preceding conventional RMGI (Vitremer).

Condition or disease Intervention/treatment Phase
Dental Caries Procedure: Dental caries was removed from primary molars and was filled with the recent filling material; Ketac Nano. Procedure: Dental caries was removed from primary molars and was filled with the conventional filling material;Vitremer Not Applicable

Detailed Description:
First, shear bond strength of each material to primary molars dentin specimens were measured (n=10) using a notched-edge crosshead. Independent sample t-test was used for statistical analysis. Then, a split mouth designed clinical trial was performed in which nano-filled RMGI; Ketac Nano (KN) and conventional RMGI; Vitremer (VR) were used to restore class I cavities of primary molars. Each material group (n=30) was evaluated according to the modified United States Public Health Service (USPHS) regarding marginal discoloration, marginal adaptation, color match, anatomic form and recurrent caries, at baseline, after one year and after two years. Wilcoxon signed- rank test and Chi-square test were used for statistical analysis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Two-year Clinical Performance in Primary Teeth of Nano-filled Versus Conventional Resin Modified Glass Ionomer Restorations
Study Start Date : June 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
Sham Comparator: Vitremer
Dental caries was removed from primary molars and was filled with the conventional filling material;Vitremer (n = 30). The right molars was always filled by Vitremer. A split-mouth design was used in the present clinical trial. Twenty nine children were involved in the present study and every one had one bilateral identical pair of carious molars except one child that had two identical pairs. This design was performed to enhance the accuracy of the present study.
Procedure: Dental caries was removed from primary molars and was filled with the conventional filling material;Vitremer
Class I carious primary molars were selected. Dental caries was removed and cavities were prepared. The conventional RMGI filling (Vitremer) was used to fill these cavities.

Active Comparator: Ketac Nano
Dental caries was removed from primary molars and was filled with the recent filling material; Ketac Nano (n=30). The left molars was always restored with Ketac Nano filling material.
Procedure: Dental caries was removed from primary molars and was filled with the recent filling material; Ketac Nano.
Class I carious primary molars were selected. Dental caries was removed and cavities were prepared. The recent nano-filled RMGI filling (Ketac Nano) was used to fill these cavities.




Primary Outcome Measures :
  1. Evidence of clinically definite deterioration of the evaluated filling materials at specific characters (parameters); marginal discoloration, marginal adaptation, color match, anatomic form and recurrent caries. [ Time Frame: 2 years ]
    The filling materials were blindly evaluated by two trained investigators at specific characters or parameters according to the modified United States Public Health Service (USPHS). Each parameter has three grades of evaluation; Alfa (A), Bravo (B) and Charlie (C) that represent the degree of deterioration of the filling materials.



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Ages Eligible for Study:   5 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The presence of a bilateral identical pair of primary molars in the same arch containing initial occlusal caries (a minimum of two pits or fissures without any cusp destruction).

Exclusion Criteria:

  • Handicapped or uncooperative children and children with extensive or rampant caries.

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): NCT02093091


Locations
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Egypt
Faculty of Dentistry, Tanta University
Tanta, Egypt, 31111
Sponsors and Collaborators
Tanta University
Investigators
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Principal Investigator: Sahar E. Abo-Hamar, DMD, PhD Tanta University, Faculty of Dentistry

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Responsible Party: Dr. Sahar E. Abo-Hamar, Doctor (DMD, PhD), Tanta University
ClinicalTrials.gov Identifier: NCT02093091     History of Changes
Other Study ID Numbers: TantaU-Nano
First Posted: March 20, 2014    Key Record Dates
Last Update Posted: March 20, 2014
Last Verified: March 2014

Keywords provided by Dr. Sahar E. Abo-Hamar, Tanta University:
nano-filled resin modified glass ionomer
clinical performance
class I
primary teeth
dentin bond strength
Filling of class I

Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Vitremer
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs