Retention Rate and Caries Preventive Effect of Preheated Flowable Resin Composite Used as a Pit and Fissure Sealant

NCT05606874 | Completed

• 1 other identifier: preheated flowable composite
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Retention rate and caries preventive effect of preheated flowable resin composite used as a pit and fissure sealant versus conventional resin-based fissure sealant in patients with permanent molars with deep pit and fissure over one year follow up. A randomized clinical trial

Conditions

Pit and Fissure Sealant

Keywords

preheated flowable composite; pit and fissure sealant; Retention Rate

Outcome Measures

Primary Outcomes (3)

• Retention rate

  Retention criteria

  T1: 3 months

• Retention rate

  Retention criteria

  T2: 6 months

• Retention rate

  Retention criteria

  T3: 12 months

Secondary Outcomes (3)

• Caries incidence

  T1: 3 months

• Caries incidence

  T2: 6 months

• Caries incidence

  T3: 12 months

Study Arms (2)

Pre-heating of flowable resin composite .

EXPERIMENTAL

(Filtek™ Z350Xt Flowable Restorative, 3M ESPSE, USA)

Other: Pre-heating of flowable resin composite used as a pit and fissure sealant.

Conventional resin fissure sealant

ACTIVE COMPARATOR

(total etch), (UltraSeal XT®, Ultradent, USA)

Other: Conventional resin fissure sealant

Interventions

Pre-heating of flowable resin composite used as a pit and fissure sealant. OTHER

The occlusal fissures will be etched with a 37% phosphoric acid gel for 30 s. After rinsing the enamel with water for 30 s the enamel will be dried for 15 s with compressed air. After completing the fissure preparations a single coat of adhesive (3M ESPE ADPER ,USA) will be applied to the etched surface ,dried under gentle air flow for 2- 3 s and light cured for 20 s using a LED light curing unit with a 1000 mw output .Conventional resin fissure sealant (total etch), (UltraSeal XT®, Ultradent, USA) will be applied to the etched pits and fissures. After removing the rubber dam the occlusion will be checked the sealant will be adjusted with a composite finishing bur and polished with polishing points.

Also known as: (Filtek™ Z350Xt Flowable Restorative, 3M ESPSE, USA)

Pre-heating of flowable resin composite .

Conventional resin fissure sealant OTHER

The occlusal fissures will be etched with a 37% phosphoric acid gel for 30 s. After rinsing the enamel with water for 30 s the enamel will be dried for 15 s with compressed air. After completing the fissure preparations a single coat of adhesive (3M ESPE ADPER ,USA) will be applied to the etched surface ,dried under gentle air flow for 2- 3 s and light cured for 20 s using a LED light curing unit with a 1000 mw output .Conventional resin fissure sealant (total etch), (UltraSeal XT®, Ultradent, USA) will be applied to the etched pits and fissures. After removing the rubber dam the occlusion will be checked the sealant will be adjusted with a composite finishing bur and polished with polishing points.

Also known as: (total etch), (UltraSeal XT®, Ultradent, USA)

Conventional resin fissure sealant

Eligibility Criteria

• Age: 16 Years - 22 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• participant:
• Young adults (16\_22y)
• Patients who have existing pits and fissures that are anatomically deep and caries susceptible.
• Teeth
• Permanent molars teeth without any caries and cavitation. (Azarpazhooh \& Main 2008)
• Permanent molar teeth that have deep pit and fissure morphology, with "sticky" fissures.
• Permanent molar teeth with stained grooves.
• Stained pits and fissures with minimum decalcification of opacification and no softness at the base of the fissure (ICDAS 1 and 2).

You may not qualify if:

• participant:
• Uncooperative behavior, limits the use of sealants due to hampering of adequate field or isolation techniques throughout the procedure.
• Patients allergic to sealant material.
• Patient with history of medical disease, drug therapies or any other serious relevant problem.
• Teeth:
• An individual with no previous caries experience and well coalesced pits and fissures
• Partially erupted teeth.
• Teeth with cavitation or caries of the dentin.
• A large restoration is present on occlusal surface.
• If pits and fissures are self-cleansable.
• Teeth with dental fluorosis, hypocalcification or hypercalcification

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, Egypt

Location

Related Publications (21)

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  PMID: 18782377 BACKGROUND

• Erbas Unverdi G, Atac SA, Cehreli ZC. Effectiveness of pit and fissure sealants bonded with different adhesive systems: a prospective randomized controlled trial. Clin Oral Investig. 2017 Sep;21(7):2235-2243. doi: 10.1007/s00784-016-2016-8. Epub 2016 Nov 30.

  PMID: 27900529 BACKGROUND

• Subramaniam P, Konde S, Mandanna DK. Retention of a resin-based sealant and a glass ionomer used as a fissure sealant: a comparative clinical study. J Indian Soc Pedod Prev Dent. 2008 Sep;26(3):114-20. doi: 10.4103/0970-4388.43192.

  PMID: 18923223 BACKGROUND

• Rickman LJ, Padipatvuthikul P, Chee B. Clinical applications of preheated hybrid resin composite. Br Dent J. 2011 Jul 22;211(2):63-7. doi: 10.1038/sj.bdj.2011.571.

  PMID: 21779058 BACKGROUND

• Ramesh H, Ashok R, Rajan M, Balaji L, Ganesh A. Retention of pit and fissure sealants versus flowable composites in permanent teeth: A systematic review. Heliyon. 2020 Sep 24;6(9):e04964. doi: 10.1016/j.heliyon.2020.e04964. eCollection 2020 Sep.

  PMID: 33005790 BACKGROUND

• Nahvi A, Razavian A, Abedi H, Charati JY. A comparison of microleakage in self-etch fissure sealants and conventional fissure sealants with total-etch or self-etch adhesive systems. Eur J Dent. 2018 Apr-Jun;12(2):242-246. doi: 10.4103/ejd.ejd_63_18.

  PMID: 29988227 BACKGROUND

• Lopes LCP, Terada RSS, Tsuzuki FM, Giannini M, Hirata R. Heating and preheating of dental restorative materials-a systematic review. Clin Oral Investig. 2020 Dec;24(12):4225-4235. doi: 10.1007/s00784-020-03637-2. Epub 2020 Oct 20.

  PMID: 33083851 BACKGROUND

• 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 BACKGROUND

• Kim HJ, Choi HJ, Kim KY, Kim KM. Effect of Heat and Sonic Vibration on Penetration of a Flowable Resin Composite Used as a Pit and Fissure Sealant. J Clin Pediatr Dent. 2020;44(1):41-46. doi: 10.17796/1053-4625-44.1.7.

  PMID: 31995416 BACKGROUND

• 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 BACKGROUND

• Irinoda Y, Matsumura Y, Kito H, Nakano T, Toyama T, Nakagaki H, Tsuchiya T. Effect of sealant viscosity on the penetration of resin into etched human enamel. Oper Dent. 2000 Jul-Aug;25(4):274-82.

  PMID: 11203831 BACKGROUND

• Ganesh M, Shobha T. Comparative evaluation of the marginal sealing ability of Fuji VII and Concise as pit and fissure sealants. J Contemp Dent Pract. 2007 May 1;8(4):10-8.

  PMID: 17486182 BACKGROUND

• 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 BACKGROUND

• Garg N, Indushekar KR, Saraf BG, Sheoran N, Sardana D. Comparative Evaluation of Penetration Ability of Three Pit and Fissure Sealants and Their Relationship with Fissure Patterns. J Dent (Shiraz). 2018 Jun;19(2):92-99.

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• Erdemir U, Sancakli HS, Yaman BC, Ozel S, Yucel T, Yildiz E. Clinical comparison of a flowable composite and fissure sealant: a 24-month split-mouth, randomized, and controlled study. J Dent. 2014 Feb;42(2):149-57. doi: 10.1016/j.jdent.2013.11.015. Epub 2013 Dec 1.

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• Dukic W, Dukic OL, Milardovic S, Vindakijevic Z. Clinical comparison of flowable composite to other fissure sealing materials--a 12 months study. Coll Antropol. 2007 Dec;31(4):1019-24.

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• 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.

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• Oba AA, Sonmez IS, Ercan E, Dulgergil T. Comparison of retention rates of fissure sealants using two flowable restorative materials and a conventional resin sealant: two-year follow-up. Med Princ Pract. 2012;21(3):234-7. doi: 10.1159/000333561. Epub 2011 Dec 8.

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• Beun S, Bailly C, Devaux J, Leloup G. Physical, mechanical and rheological characterization of resin-based pit and fissure sealants compared to flowable resin composites. Dent Mater. 2012 Apr;28(4):349-59. doi: 10.1016/j.dental.2011.11.001. Epub 2011 Nov 25.

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• Aguilar FG, Drubi-Filho B, Casemiro LA, Watanabe MG, Pires-de-Souza FC. Retention and penetration of a conventional resin-based sealant and a photochromatic flowable composite resin placed on occlusal pits and fissures. J Indian Soc Pedod Prev Dent. 2007 Oct-Dec;25(4):169-73. doi: 10.4103/0970-4388.37012.

  PMID: 18007102 BACKGROUND

MeSH Terms

Conditions

Van der Woude syndrome

Interventions

Pit and Fissure Sealants; Ultra Seal XT

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Eman Abouauf, Ass.prof

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: operator, data entry and corresponding author; B.D.S. Cairo University (2016), Conservative Dentistry Department, Faculty of Dentistry, Cairo University. Egypt

Study Record Dates

• First Submitted: October 29, 2022
• First Posted: November 7, 2022
• Study Start: November 20, 2022
• Primary Completion: November 20, 2023
• Study Completion: May 10, 2024
• Last Updated: May 14, 2024

Record last verified: 2022-03

Locations

EG (1)