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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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
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Pit and Fissure Sealant

Intervention / Treatment
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* Other: Pre-heating of flowable resin composite used as a pit and fissure sealant.
* Other: Conventional resin fissure sealant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). - Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-heating of flowable resin composite .<br>(Filtek™ Z350Xt Flowable Restorative, 3M ESPSE, USA) | Other: Pre-heating of flowable resin composite used as a pit and fissure sealant.<br>* 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.<br>* Other names: (Filtek™ Z350Xt Flowable Restorative, 3M ESPSE, USA);|
| Active Comparator: Conventional resin fissure sealant<br>(total etch), (UltraSeal XT®, Ultradent, USA) | Other: Conventional resin fissure sealant<br>* 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.<br>* Other names: (total etch), (UltraSeal XT®, Ultradent, USA);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention rate | Retention criteria | T1: 3 months | 
| Retention rate | Retention criteria | T2: 6 months | 
| Retention rate | Retention criteria | T3: 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries incidence | ICDAS-II visual criteria | T1: 3 months | 
| Caries incidence | ICDAS-II visual criteria | T2: 6 months | 
| Caries incidence | ICDAS-II visual criteria | T3: 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preheated flowable composite, pit and fissure sealant, Retention Rate