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Clinical Trials/NCT05606874
NCT05606874CompletedNot Applicable

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

Cairo University1 site in 1 country28 target enrollmentStarted: November 20, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
28
Locations
1
Primary Endpoint
Retention rate

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
16 Years to 22 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • participant:
  • Young adults (16_22y)
  • Patients who have existing pits and fissures that are anatomically deep and caries susceptible.
  • 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.
  • 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

Outcomes

Primary Outcomes

Retention rate

Time Frame: T3: 12 months

Retention criteria

Secondary Outcomes

  • Caries incidence(T3: 12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

safa abd alwahab natiq

operator, data entry and corresponding author; B.D.S. Cairo University (2016), Conservative Dentistry Department, Faculty of Dentistry, Cairo University. Egypt

Cairo University

Study Sites (1)

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