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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04701294
Other study ID # 0647-FO-UPG-20
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2021
Est. completion date August 2022

Study information

Verified date January 2021
Source National University of San Marcos, Peru
Contact Catherine Ruiz Yasuda, Doctor
Phone 51-952212882
Email cruizy@unmsm.edu.pe
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Objective: Determine which of the two sealants has better retention during the periods of 6, 9 and 12 months, one based on flowable resin with sprg or the other only based on flowable resin and we have the following hypothesis: the retention of the sealant based on a flowable resin with sprg is greater than a sealant based on a flowable resin in permanent first molars at different periods ". Materials and methods: 60 children from the school in the district of Pichanaki, Peru and aged 6 to 8 years were included in this study. The Split mouth design will be adopted, and 120 permanent first molars are designated.It will be applied on the upper / lower first molars with sealant material being the order assigned according to the previous randomization, for the intervention group they will be sealed based on flowable resin with sprg (giomer F03 beautifil-Shofu) in association with a bottle of adhesive (single bond) and on the contralateral side the upper / lower first molars will be sealed, the control group will be sealed with a flowable resin-based resin compound (Tetric N-Flow ivoclar vivadent) in association with a bottle of adhesive (Single Bond). Placement of materials on the right / left side of the mouth will be randomly assigned following block randomization procedures with a 1:1 allocation using the random block sizes of 4 and 8 (35).A computerized random number generator will be used. A total of 120 upper / lower molar teeth will be sealed with both materials (60 teeth for each material). The materials will be placed by the same operator according to the protocol of UNMSM for the sealing of pits and deep fissures; then, the interventional group will be compared after a 12-month follow-up with controls at 6, 9 and 12 months. The statistical analysis will be with SPSS software 20.0. Since all the data in this study will be categorical, nonparametric statistics will be used. Expected result: After the evaluation period it is expected to find significant differences in the retention of the sealant to flowable resin base with sprg (giomer F03 beautifil -Shofu) and sealant based on flowable resin (Tetric N- Flow ivoclar vivadent) using an adhesive system . Conclusion: Identify and quantify the retention of a sealant based on flowable resin with sprg (giomer F03 Beautifil -Shofu) and a sealant based on flowable resin (Tetric N-Flow ivoclar vivadent) using an adhesive system on 12 months.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Device:
Giomer Beautifil flow plusF03 Shofu-Japan
A pair of permanent first molars will be used for each participant homologs The operator will apply in the upper / lower first molars the sealant material in the order assigned according to the previous randomization. For the intervention group, they will be sealed based on a fluid resin with s-prg glass ionomer filling (Giomer F03 Beautiful -Shofu) in association with a bottle of adhesive (Single Bond) . The evaluation and monitoring process; another operator will record the retention of the sealant in a period of 6, 9 and 12 months.
Tetric N flow ivoclar vivadent-Germany
And on the contralateral side (control) the first upper / lower molars will be sealed will be sealed with a fluid resin compound (Tetric N-Flow ivoclar vivadent) in association with a bottle of adhesive (Single Bond). Both materials have a similar color. The operator and the child will not be informed about the brand of the material used. The assistant will collect the data in the file. The evaluation and monitoring process; another operator will record the retention of the sealant in a period of 6, 9 and 12 months.

Locations

Country Name City State
Peru Manuel Gonzales Prada School Alto Pichanaki Chanchamayo

Sponsors (1)

Lead Sponsor Collaborator
Catherine Christie Ruiz Yasuda

Country where clinical trial is conducted

Peru, 

References & Publications (41)

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Outcome

Type Measure Description Time frame Safety issue
Primary Retention of sealants Determine which of the two sealants has better retention during the period of 12 months, one based on flowable resin with sprg the other only based on flowable resin 12 months
Secondary Clinical preservation Evaluate of clinical preservation of a sealant based on flowable resin with sprg and another based on flowable resin in first permanent molars, in the period of 12 months 12 months
Secondary Survival curve Estimate the survival curve of a sealant based on flowable resin with sprg and another based on flowable resin in first permanent molars, in the period of 12 months. 12 months
Secondary Survival of the sealant Compare the survival of a sealant based on flowable resin with sprg and another based on flowable resin in first permanent molars, in the period of 12 months 12 months
See also
  Status Clinical Trial Phase
Completed NCT05606874 - Retention Rate and Caries Preventive Effect of Preheated Flowable Resin Composite Used as a Pit and Fissure Sealant N/A
Completed NCT04127357 - Progression of Active Microcavitated Carious Lesions on Primary Molar Occlusal Surfaces N/A

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