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

September 4, 2023 updated by: safa abd alwahab natiq, Cairo University

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 22 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pre-heating of flowable resin composite .
(Filtek™ Z350Xt Flowable Restorative, 3M ESPSE, USA)
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.
Other Names:
  • (Filtek™ Z350Xt Flowable Restorative, 3M ESPSE, USA)
Active Comparator: Conventional resin fissure sealant
(total etch), (UltraSeal XT®, Ultradent, USA)
Other: 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.
Other Names:
  • (total etch), (UltraSeal XT®, Ultradent, USA)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Eman Abouauf, Ass.prof, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 20, 2023

Primary Completion (Estimated)

November 20, 2023

Study Completion (Estimated)

December 10, 2024

Study Registration Dates

First Submitted

October 29, 2022

First Submitted That Met QC Criteria

November 3, 2022

First Posted (Actual)

November 7, 2022

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 4, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • preheated flowable composite

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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