Clinical Evaluation of Nanoionomer Filling in Primary Teeth (CENFPT)

Tanta University

Status: Completed

Conditions: Dental Caries

Treatments: Procedure: Dental caries was removed from primary molars and was filled with the conventional filling material;Vitremer; Procedure: Dental caries was removed from primary molars and was filled with the recent filling material; Ketac Nano.

Study type: Interventional

Funder types: Other

Identifiers

NCT02093091

TantaU-Nano

Details and patient eligibility

About

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).

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 5 to 8 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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29 participants in 2 patient groups

Vitremer

Sham Comparator group

Description:

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.

Treatment:

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

Ketac Nano

Active Comparator group

Description:

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.

Treatment:

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