Retention of a Flowable Resin-based Sealant With Two Types of Adhesives

NCT04945382 | Unknown

• 1 other identifier: A20052171
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to compare the use of two adhesives for the placement of occlusal sealants, evaluating their retention on the occlusal surfaces. Methods: A randomized clinical trial, in Phase IV, triple-blind, with a split mouth study design will be adopted, 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. They will then be randomly assigned following block randomization procedures with a 1: 1 allocation. 50 participants (6-year-old children) will be considered, and a pair of permanent first molars homologs will be used for each participant. Inclusion criteria include: children whose parents accepted their participation in the study and who signed the Informed Consent, children enrolled in the Pichanaki District school, children who present upper and / or lower permanent molars with absence of deep caries cavities and caries, graded 0 and 1 according to ICDAS II, Green and Vermillion Simplified Oral Hygiene Index of 1-2, have a pair of non-cavitated caries-free counterparts, and children with positive behavior. After selection of patients, the dental sealants will be placed with two different adhesives: the 8th generation adhesive intervention group (Scotchbond universal 3M) and the 5th generation adhesive control group (Single bond 3M), both sealants will use the same flowable resin (Tetric N-flow ivoclar vivadent). Results evaluation: Retention of the sealants will be evaluated at 6, 9 and 12 months. Retention rates of pit and fissure sealant materials will be analyzed according to the split mouth design. The study will use the Mc Nemar test to compare the retention of sealants in the intervention group and the control group at 6, 9 and 12 months. A 95% confidence level will be accepted. In addition, the Cochrane Q test will be applied to determine if there are significant differences in survival for each group of sealants through the evaluation time. The calculation of the survival months of the sealants will be carried out using the actuarial method (survival tables). Expected conclusion: To identify which of the two adhesives presents the best retention after 12 months.

Conditions

Caries,Dental; Pit and Fissure Caries; Sealant Dental

Outcome Measures

Primary Outcomes (1)

• Clinical Retention of adhesives

  Determine which of the two adhesives has better clinical retention during the period of 12 months, one with Scotchbond Universal 3M adhesive and the other with Single bond 3M adhesive.

  12 months

Secondary Outcomes (3)

• Clinical preservation of sealats

  12 months

• .Survival curve of sealants

  12 months

• Survivability of sealant

  12 months

Study Arms (2)

Scotchbond universal 3M

EXPERIMENTAL

Application of dental sealant with Scotchbond universal 3M adhesive.

Device: Scotchbond Universal 3M

Control (Single bond 3M)

ACTIVE COMPARATOR

Application of dental sealant with Single Bond 3M adhesive

Device: Single Bond 3M

Interventions

Scotchbond Universal 3M DEVICE

The occlusal surfaces will be cleaned using water, a brush and a low-pressure handpiece; they will wash and dry; then deproteinization will be done with sodium hypochlorite (5.25%) for 60 seconds, it will be washed with a water / air spray for 30s; it will dry up; The tooth will then be etched using a 37% orthophosphoric acid gel for 15 seconds, rinsed with a water / air spray for 30 seconds, and dried with cotton balls. Scotchbond universal 3M to the etched surface will be dried under a gentle air flow for 2-3 s, and light cured for 11 s using an LED curing unit with an output of 1500 mW / cm2 (Balloon.).

Scotchbond universal 3M

Single Bond 3M DEVICE

The occlusal surfaces will be cleaned using water, a brush and a low-pressure handpiece; they will wash and dry; then deproteinization will be done with sodium hypochlorite (5.25%) for 60 seconds, it will be washed with a water / air spray for 30s; it will dry up; The tooth will then be etched using a 37% orthophosphoric acid gel for 15 seconds, rinsed with a water / air spray for 30 seconds, and dried with cotton balls. Single Bond 3M to the etched surface will be dried under a gentle air flow for 2-3 s, and light cured for 11 s using an LED curing unit with an output of 1500 mW / cm2 (Balloon.).

Control (Single bond 3M)

Eligibility Criteria

• Age: 72 Months - 83 Months
• 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
• Children enrolled in the Pichanaki District school, Chanchamayo province, in Junin department 6-year-old children, who present upper and / or lower permanent molars with the following characteristics:
• Absence of deep caries cavities and caries, graded 0 and 1 according to ICDAS II
• Green and Vermillion Simplified Oral Hygiene Index (OHI) of 1-2
• Have a pair of non-cavitated caries-free counterparts.
• Children with positive behavior.

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 residing outside the city

Sponsors & Collaborators

• National University of San Marcos, Peru: lead

Study Sites (1)

Nido 380

Alto Pichanaki, Chanchamayo, Peru

Location

Related Publications (16)

• Alirezaei M, Bagherian A, Sarraf Shirazi A. Glass ionomer cements as fissure sealing materials: yes or no?: A systematic review and meta-analysis. J Am Dent Assoc. 2018 Jul;149(7):640-649.e9. doi: 10.1016/j.adaj.2018.02.001. Epub 2018 May 4.

  PMID: 29735163 RESULT

• Aman N, Khan FR, Salim A, Farid H. A randomized control clinical trial of fissure sealant retention: Self etch adhesive versus total etch adhesive. J Conserv Dent. 2015 Jan-Feb;18(1):20-4. doi: 10.4103/0972-0707.148883.

  PMID: 25657521 RESULT

• Dikmen B. Icdas II criteria (international caries detection and assessment system). J Istanb Univ Fac Dent. 2015 Oct 21;49(3):63-72. doi: 10.17096/jiufd.38691. eCollection 2015.

  PMID: 28955548 RESULT

• Ekstrand KR, Gimenez T, Ferreira FR, Mendes FM, Braga MM. The International Caries Detection and Assessment System - ICDAS: A Systematic Review. Caries Res. 2018;52(5):406-419. doi: 10.1159/000486429. Epub 2018 Mar 8.

  PMID: 29518788 RESULT

• Gugnani N, Pandit IK, Srivastava N, Gupta M, Sharma M. International Caries Detection and Assessment System (ICDAS): A New Concept. Int J Clin Pediatr Dent. 2011 May-Aug;4(2):93-100. doi: 10.5005/jp-journals-10005-1089. Epub 2010 Apr 15.

  PMID: 27672245 RESULT

• Hou J, Gu Y, Zhu L, Hu Y, Sun M, Xue H. Systemic review of the prevention of pit and fissure caries of permanent molars by resin sealants in children in China. J Investig Clin Dent. 2017 Feb;8(1). doi: 10.1111/jicd.12183. Epub 2015 Aug 14.

  PMID: 26272130 RESULT

• Jafarzadeh M, Malekafzali B, Tadayon N, Fallahi S. Retention of a Flowable Composite Resin in Comparison to a Conventional Resin-Based Sealant: One-year Follow-up. J Dent (Tehran). 2010 Winter;7(1):1-5. Epub 2010 Mar 31.

  PMID: 21998768 RESULT

• Karaman E, Yazici AR, Tuncer D, Firat E, Unluer S, Baseren M. A 48-month clinical evaluation of fissure sealants placed with different adhesive systems. Oper Dent. 2013 Jul-Aug;38(4):369-75. doi: 10.2341/12-181-C. Epub 2012 Dec 4.

  PMID: 23210859 RESULT

• Khare M, Suprabha BS, Shenoy R, Rao A. Evaluation of pit-and-fissure sealants placed with four different bonding protocols: a randomized clinical trial. Int J Paediatr Dent. 2017 Nov;27(6):444-453. doi: 10.1111/ipd.12281. Epub 2016 Dec 26.

  PMID: 28024165 RESULT

• Maher MM, Elkashlan HI, El-Housseiny AA. Effectiveness of a self-etching adhesive on sealant retention in primary teeth. Pediatr Dent. 2013 Jul-Aug;35(4):351-4.

  PMID: 23930635 RESULT

• Rishika, Garg N, Mayall SS, Pathivada L, Yeluri R. Combined Effect of Enamel Deproteinization and Intermediate Bonding in the Retention of Pit and Fissure Sealants in Children: A Randomized Clinical Trial. J Clin Pediatr Dent. 2018;42(6):427-433. doi: 10.17796/1053-4625-42.6.4. Epub 2018 Aug 7.

  PMID: 30085876 RESULT

• Muller-Bolla M, Courson F, Lupi-Pegurier L, Tardieu C, Mohit S, Staccini P, Velly AM. Effectiveness of Resin-Based Sealants with and without Fluoride Placed in a High Caries Risk Population: Multicentric 2-Year Randomized Clinical Trial. Caries Res. 2018;52(4):312-322. doi: 10.1159/000486426. Epub 2018 Mar 1.

  PMID: 29495020 RESULT

• Fracasso Mde L, Rios D, Machado MA, Silva SM, Abdo RC. Avaliacao da microinfiltracao marginal e profundidade de penetracao dos cimentos de ionomero de vidro utilizados como selantes oclusais. J Appl Oral Sci. 2005 Sep;13(3):269-74. doi: 10.1590/s1678-77572005000300013.

  PMID: 20878029 RESULT

• Wadhwa S, A Nayak U, Kappadi D, Prajapati D, Sharma R, Pawar A. Comparative Clinical Evaluation of Resin-based Pit and Fissure Sealant and Self-adhering Flowable Composite: An In Vivo Study. Int J Clin Pediatr Dent. 2018 Sep-Oct;11(5):430-434. doi: 10.5005/jp-journals-10005-1552. Epub 2018 Oct 1.

  PMID: 30787558 RESULT

• Tandon V, Lingesha RT, Tangade PS, Tirth A, Pal SK, Lingesha CT, Arora V, Yadav V. Effect of Adhesive Application on Sealant Success: A Clinical Study of Fifth and Seventh Generation Adhesive Systems. J Dent (Tehran). 2015 Oct;12(10):712-9.

  PMID: 27252754 RESULT

• Topal BG, Kirzioglu Z. Evaluation of the fissure sealants applied to erupting permanent molars in accordance to eruption stages: A prospective study. Niger J Clin Pract. 2019 Nov;22(11):1495-1502. doi: 10.4103/njcp.njcp_534_18.

  PMID: 31719270 RESULT

MeSH Terms

Conditions

Dental Caries; Van der Woude syndrome

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Gilmer Torres Ramos

CONTACT

01 993161289; gtorresr@unmsm.edu.pe

Mayra Barahona Hernandez

CONTACT

01 991736616; mbarahonah6788@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS,PhD

Model Details: A split mouth study design will be adopted , 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. They will then be randomly assigned following block randomization procedures with a 1: 1 allocation using the random block sizes of 4 and 8. A computerized random number generator and combinations will be used to select the tooth and material to be sealed first.

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 30, 2021
• Study Start: June 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: September 1, 2022
• Last Updated: June 30, 2021

Record last verified: 2021-06

Locations

PE (1)