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Completed

NCT Number: NCT02093091

Clinical Evaluation of Nanoionomer Filling in Primary Teeth

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).

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Tanta University

Tanta, 31111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Dental caries was removed from primary molars and was filled with the recent filling material; Ketac Nano.

Procedure

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.

Dental caries was removed from primary molars and was filled with the conventional filling material;Vitremer

Procedure

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.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Two-year Clinical Performance in Primary Teeth of Nano-filled Versus Conventional Resin Modified Glass Ionomer Restorations

Acronym: CENFPT

Important dates

Study start
2011
Primary completion
2011
Study completion
2013
First posted
Mar 20, 2014
Registry last updated
Mar 20, 2014

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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