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

Pit and Fissure Sealant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05606874
• Other study ID #: preheated flowable composite
• Status: Completed
• Phase: N/A
• Start date: November 20, 2022
• Est. completion date: May 10, 2024

Study information

• Verified date: March 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Statement of the problem:

Pit and fissure sealant placement is considered as an effective modality for prevention of caries on occlusal surfaces. Penetration, retention and lateral wall adaptation are the key factors in success of pit and fissure sealant restorations .

The retention is very critical for the sealing material and the successful penetration of the material into the pits and fissures However, the morphology of the fissures significantly influences the penetration of the sealing material occlusal fissure pattern like in deep and narrow fissures like I-type and IK- type where lesser penetration may be encountered fillers are added to the pit and fissure sealants in order to increase their wear and abrasion resistance. However, these fillers could lead to increase in the viscosity with subsequent decrease in the penetration.

Rationale:

According to a systematic review, they found that preheating of resin composite apparently increases the flowability of regular consistency composites, which improves the adaptation of the material into the cavity walls. Also studied the effect of heat and sonic vibration on penetration of flowable resin composite, they found that higher penetration was associated with heat compared with the conventional application method. So, this proposal is introduced with the hypothesis that preheating of filled fissure sealants may enhance their flowability and penetration especially into those fissures with complex structure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 10, 2024
• Est. primary completion date: November 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 22 Years

Eligibility

Inclusion Criteria:

participant:

1. Young adults (16_22y)

2. Patients who have existing pits and fissures that are anatomically deep and caries susceptible.

Teeth

1. Permanent molars teeth without any caries and cavitation. (Azarpazhooh & Main 2008)

2. Permanent molar teeth that have deep pit and fissure morphology, with "sticky" fissures.

3. Permanent molar teeth with stained grooves.

4. Stained pits and fissures with minimum decalcification of opacification and no softness at the base of the fissure (ICDAS 1 and 2).

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Exclusion Criteria:

participant:

1. Uncooperative behavior, limits the use of sealants due to hampering of adequate field or isolation techniques throughout the procedure.

2. Patients allergic to sealant material.

3. Patient with history of medical disease, drug therapies or any other serious relevant problem.

Teeth:

1. An individual with no previous caries experience and well coalesced pits and fissures

2. Partially erupted teeth.

3. Teeth with cavitation or caries of the dentin.

4. A large restoration is present on occlusal surface.

5. If pits and fissures are self-cleansable.

6. Teeth with dental fluorosis, hypocalcification or hypercalcification

Related Conditions & MeSH terms

• Pit and Fissure Sealant

Intervention

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

Locations

Country	Name	City	State
Egypt	Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (21)

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. — View Citation

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. — View Citation

Bagherian A, Shirazi AS. Flowable composite as fissure sealing material? A systematic review and meta-analysis. Br Dent J. 2018 Jan 26;224(2):92-97. doi: 10.1038/sj.bdj.2018.40. Erratum In: Br Dent J. 2018 Feb 23;224(4):254. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Featherstone JD. Dental caries: a dynamic disease process. Aust Dent J. 2008 Sep;53(3):286-91. doi: 10.1111/j.1834-7819.2008.00064.x. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention rate	Retention criteria	T1: 3 months
Primary	Retention rate	Retention criteria	T2: 6 months
Primary	Retention rate	Retention criteria	T3: 12 months
Secondary	Caries incidence	ICDAS-II visual criteria	T1: 3 months
Secondary	Caries incidence	ICDAS-II visual criteria	T2: 6 months
Secondary	Caries incidence	ICDAS-II visual criteria	T3: 12 months