Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05606874
Enrollment
28
Registered
2022-11-07
Start date
2022-11-20
Completion date
2024-05-10
Last updated
2024-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pit and Fissure Sealant

Keywords

preheated flowable composite, pit and fissure sealant, Retention Rate

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

Detailed 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.

Interventions

OTHERPre-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.

OTHERConventional 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 22 Years
Healthy volunteers
Yes

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). \-

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

Design outcomes

Primary

MeasureTime frameDescription
Retention rateT1: 3 monthsRetention criteria

Secondary

MeasureTime frameDescription
Caries incidenceT1: 3 monthsICDAS-II visual criteria

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026