Retention of Flowable Resin With Sprg and of a Flowable Resin in First Permanent Molars

NCT04701294 | Unknown

• 1 other identifier: 0647-FO-UPG-20
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pit and Fissure Sealant

Keywords

pit and fissure sealant; glass ionomer; resin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Clinical preservation

  12 months

• Survival curve

  12 months

• Survival of the sealant

  12 months

Study Arms (2)

Giomer Beautifil flow plusF03 Shofu-Japan

EXPERIMENTAL

Giomer beautifil flow plusF03 shofu-Japan an application of flowable resin with sprg as a sealant for pits and fissures on the occlusal surface of permanent first molars until the end of the experiment.

Device: Giomer Beautifil flow plusF03 Shofu-Japan

Tetric N flow ivoclar vivadent-Germany

ACTIVE COMPARATOR

Tetric N flow ivoclar vivadent-Germany an application of flowable resin a sealant for pits and fissures on the occlusal surface of permanent first molars until the end of the comparator.

Device: Tetric N flow ivoclar vivadent-Germany

Interventions

Giomer Beautifil flow plusF03 Shofu-Japan DEVICE

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.

Also known as: Experimental

Giomer Beautifil flow plusF03 Shofu-Japan

Tetric N flow ivoclar vivadent-Germany DEVICE

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.

Also known as: Control

Tetric N flow ivoclar vivadent-Germany

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children whose parents accepted their participation in the study and who signed the Informed Consent (Annex 1)
• Children enrolled in the school of the district of Pichanaki, province of Chanchamayo and department of Junín
• Children between 6 and 8 years, with permanent upper and / or lower molars with the following characteristics:
• Deep cavities and cavities free of cavities, rated 0 and 1 according to ICDAS II Non-cavitated caries in enamel C1 according to ICDAS II Green and Vermillion Simplified Oral Hygiene Index (OHS) of 1 Have a pair of non-cavitated caries-free counterparts.
• Collaborative and receptive children.

You may not qualify if:

• Children with the presence of a deep dental caries lesion, with pulp exposure, history of pain and presence of fistula or abscess adjacent to decayed tooth.
• Medically compromised children
• Children with developmental enamel defects.
• Children with a known allergy to any of the resins used
• Children with previously placed sealants or restorations
• Children with bruxism or malocclusion
• Children residing outside the city.
• Children with poor hygiene
• Criteria for withdrawal of research subjects
• When they did not attend the evaluations
• If the participant has partial retention and total loss of the sealant, he will be withdrawn from the study after placing a new sealant.
• If a patient moves to another region, it will be grounds for withdrawal from the study.
• If the patient wishes to leave the study, they are considered outside the study
• Criteria for termination or interruption of the clinical trial.
• When the 12-month follow-up of all the recruited patients, excluding the withdrawn ones, is completed, the study will be terminated.

Sponsors & Collaborators

• Catherine Christie Ruiz Yasuda: lead

Study Sites (1)

Manuel Gonzales Prada School

Alto Pichanaki, Chanchamayo, Peru

Location

Related Publications (41)

• Nayhua Gamarra L, Grados Soto F, Llallico Huancaya W, Portocarrero Pechiarovich J, Virhuez Díaz T, Cruz Martínez A, et al. Technical Document Epidemiological Profile of Oral Health in school children from 3 to 15 years old, Peru 2012-2014; 1-82

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Related Links

• Use of Glass Ionomer Cement: A Systematic Review. Pesqui Bras Odontopediatria Clin Integr. 2010; 10 (2): 301-7.
• Clinical Evaluation of Sealants Made with Resin Modified Glass Ionomer Cement (Vitremer®) in Primary Molars. Brazilian Research in Pediatric Dentistry and Integrated Clinic. 2010; 10 (2), 233-240.
• Minsa. Clinical practice guide for the prevention, diagnosis and treatment of dental caries in boys and girls.Resolution Minist N ° 422-2017 / MINSA \[Internet\]. 2017; 41
• National Center for Epidemiology, Disease Prevention and Control. Burden of disease in Peru: Estimation of healthy years of life lost 2016 part I. 2018; part I.
• National Center for Epidemiology, Prevention and Control of Diseases. Estimation of healthy years of life lost 2016. Enferm Burden in Peru \[Internet\].2018; Part II: 22-44.
• Cogo E, Calura G. Clinical evaluation of two materials Ußed As P I T and Fissure Sealants :2-year follow-up. International Journal of Clinical Dentistry Volume 2, Issue 4
• Regulations for Clinical Trials are approved. El Peruano, pp. 38-67.
• World medical association. Wma declaration of helsinki - ethical principles for medical investigations in human beings. 2017
• Vaillard-Jiménez, E \& Huitzil-Muñoz, E \& Ortega, Ai \& García-Damián S. Dimensional Characteristics of Fissures and Enamel Fissures of Temporary Molars. Rev Colomb Investig en Odontol \[Internet\]. 2013; 12 (2): 102-109.
• Latin American Association of Pediatric Dentistry. Care Route for Pediatric Dental Procedures During the Confinement or Quarantine of the COVID-19 Pandemic: Dental EMERGENCY-URGENCY Consultation.2020; 10: 2-4
• National cancer institute. NHI INFORMED CONSENT \[Internet\]. 2020 p. 163-6

MeSH Terms

Conditions

Van der Woude syndrome

Study Officials

• Catherine Ruiz Yasuda, Doctor

  Faculty of dentistry UNMSM.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Ruiz Yasuda, Doctor

CONTACT

51-952212882; cruizy@unmsm.edu.pe

Gilmer Torres Ramos, Doctor

CONTACT

51-993161289; gtorresr@unmsm.edu.pe

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Regarding the patient data, it will only be handled by the programmer who will be in charge of coding, randomizing the first permanent molars, randomizing the materials to be used so that it is placed in the first permanent molars and this information will be given to the coordinator so that the put in sealed envelopes and then these sealed envelopes will be given to an outside assistant so that such data is not disclosed or published. Assistant 3 (in charge of labeling with kraft paper and listing the intervention material(giomer F03 beautifil-shofu and Tetric N-Flow ivoclar vivadent) with the research coordinator. The evaluators did not do the intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor Catherine Christie Ruiz Yasuda

Model Details: A split mouth (120 teeth) study design will be adopted (19.20), which consists of a simple division of the mouth into two parts (right and left) for the first four permanent molars of each patient, where the placement of the materials will be on the right / left side of the mouth and contralateral.

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 8, 2021
• Study Start: March 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: August 1, 2022
• Last Updated: January 8, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

PE (1)