Clinical trial NCT05606874: Retention Rate and Caries Preventive Effect of Preheated Flowable Resin Composite Used as a Pit and Fissure Sealant
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pit and Fissure Sealant
Keywords: preheated flowable composite
pit and fissure sealant
Retention Rate
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-11-07
Enrollment: 28
Sex: ALL
Minimum age (years): 16
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Retention rate
timeFrame: T1: 3 months
measure: Retention rate
timeFrame: T2: 6 months
measure: Retention rate
timeFrame: T3: 12 months
Secondary outcomes:
measure: Caries incidence
timeFrame: T1: 3 months
measure: Caries incidence
timeFrame: T2: 6 months
measure: Caries incidence
timeFrame: T3: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
affiliation: Cairo University
name: Eman Abouauf, Ass.prof
role: STUDY_DIRECTOR
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