Pit and Fissure SealantNCT05606874
Retention Rate and Caries Preventive Effect of Preheated Flowable Resin Composite Used as a Pit and Fissure Sealant
A study testing Pre-heating of flowable resin composite used as a pit and fissure sealant. and Conventional resin fissure sealant in people with Pit and Fissure Sealant, run by Cairo University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 16 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Pit and Fissure Sealant
- What is being tested?
- Pre-heating of flowable resin composite used as a pit and fissure sealant. and Conventional resin fissure sealant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Nov 2022to 10 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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).
- -
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Pit and Fissure Sealant
- Being tested
- Pre-heating of flowable resin composite used as a pit and fissure sealant., Conventional resin fissure sealant
- Keywords
- preheated flowable composite, pit and fissure sealant, Retention Rate
- Medical subject headings
- Van der Woude syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-heating of flowable resin composite used as a pit and fissure sealant.Other
Also called (Filtek™ Z350Xt Flowable Restorative, 3M ESPSE, USA)
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.
Conventional resin fissure sealantOther
Also called (total etch), (UltraSeal XT®, Ultradent, USA)
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-heating of flowable resin composite . | Experimental | (Filtek™ Z350Xt Flowable Restorative, 3M ESPSE, USA) Receives: Other: Pre-heating of flowable resin composite used as a pit and fissure sealant. |
| Conventional resin fissure sealant | Active comparator | (total etch), (UltraSeal XT®, Ultradent, USA) Receives: Other: Conventional resin fissure sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rate
Retention criteria
Measured: T1: 3 months
Retention rate
Retention criteria
Measured: T2: 6 months
Retention rate
Retention criteria
Measured: T3: 12 months
Secondary outcomes (3)
Caries incidence
ICDAS-II visual criteria
Measured: T1: 3 months
Caries incidence
ICDAS-II visual criteria
Measured: T2: 6 months
Caries incidence
ICDAS-II visual criteria
Measured: T3: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start20 Nov 2022
- Primary completion20 Nov 2023
- Study completion10 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Pit and Fissure SealantStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, safa abd alwahab natiq, Cairo University
- Investigators
- Eman Abouauf, Ass.prof, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606874
- Sponsor's protocol ID
- preheated flowable composite
- Status last verified
- Mar 2022
- First submitted
- 29 Oct 2022
- Last updated
- 14 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Featherstone JD. Dental caries: a dynamic disease process. Aust Dent J. 2008 Sep;53(3):286-91. doi: 10.1111/j.1834-7819.2008.00064.x.
PubMed 18782377Erbas Unverdi G, Atac SA, Cehreli ZC. Effectiveness of pit and fissure sealants bonded with different adhesive systems: a prospective randomized controlled trial. Clin Oral Investig. 2017 Sep;21(7):2235-2243. doi: 10.1007/s00784-016-2016-8. Epub 2016 Nov 30.
PubMed 27900529Subramaniam P, Konde S, Mandanna DK. Retention of a resin-based sealant and a glass ionomer used as a fissure sealant: a comparative clinical study. J Indian Soc Pedod Prev Dent. 2008 Sep;26(3):114-20. doi: 10.4103/0970-4388.43192.
PubMed 18923223Rickman LJ, Padipatvuthikul P, Chee B. Clinical applications of preheated hybrid resin composite. Br Dent J. 2011 Jul 22;211(2):63-7. doi: 10.1038/sj.bdj.2011.571.
PubMed 21779058Ramesh H, Ashok R, Rajan M, Balaji L, Ganesh A. Retention of pit and fissure sealants versus flowable composites in permanent teeth: A systematic review. Heliyon. 2020 Sep 24;6(9):e04964. doi: 10.1016/j.heliyon.2020.e04964. eCollection 2020 Sep.
PubMed 33005790Nahvi A, Razavian A, Abedi H, Charati JY. A comparison of microleakage in self-etch fissure sealants and conventional fissure sealants with total-etch or self-etch adhesive systems. Eur J Dent. 2018 Apr-Jun;12(2):242-246. doi: 10.4103/ejd.ejd_63_18.
PubMed 29988227Lopes LCP, Terada RSS, Tsuzuki FM, Giannini M, Hirata R. Heating and preheating of dental restorative materials-a systematic review. Clin Oral Investig. 2020 Dec;24(12):4225-4235. doi: 10.1007/s00784-020-03637-2. Epub 2020 Oct 20.
PubMed 33083851Khare M, Suprabha BS, Shenoy R, Rao A. Evaluation of pit-and-fissure sealants placed with four different bonding protocols: a randomized clinical trial. Int J Paediatr Dent. 2017 Nov;27(6):444-453. doi: 10.1111/ipd.12281. Epub 2016 Dec 26.
PubMed 28024165Kim HJ, Choi HJ, Kim KY, Kim KM. Effect of Heat and Sonic Vibration on Penetration of a Flowable Resin Composite Used as a Pit and Fissure Sealant. J Clin Pediatr Dent. 2020;44(1):41-46. doi: 10.17796/1053-4625-44.1.7.
PubMed 31995416Jafarzadeh M, Malekafzali B, Tadayon N, Fallahi S. Retention of a Flowable Composite Resin in Comparison to a Conventional Resin-Based Sealant: One-year Follow-up. J Dent (Tehran). 2010 Winter;7(1):1-5. Epub 2010 Mar 31.
PubMed 21998768Irinoda Y, Matsumura Y, Kito H, Nakano T, Toyama T, Nakagaki H, Tsuchiya T. Effect of sealant viscosity on the penetration of resin into etched human enamel. Oper Dent. 2000 Jul-Aug;25(4):274-82.
PubMed 11203831Ganesh M, Shobha T. Comparative evaluation of the marginal sealing ability of Fuji VII and Concise as pit and fissure sealants. J Contemp Dent Pract. 2007 May 1;8(4):10-8.
PubMed 17486182Rishika, Garg N, Mayall SS, Pathivada L, Yeluri R. Combined Effect of Enamel Deproteinization and Intermediate Bonding in the Retention of Pit and Fissure Sealants in Children: A Randomized Clinical Trial. J Clin Pediatr Dent. 2018;42(6):427-433. doi: 10.17796/1053-4625-42.6.4. Epub 2018 Aug 7.
PubMed 30085876Garg N, Indushekar KR, Saraf BG, Sheoran N, Sardana D. Comparative Evaluation of Penetration Ability of Three Pit and Fissure Sealants and Their Relationship with Fissure Patterns. J Dent (Shiraz). 2018 Jun;19(2):92-99.
PubMed 29854882Erdemir U, Sancakli HS, Yaman BC, Ozel S, Yucel T, Yildiz E. Clinical comparison of a flowable composite and fissure sealant: a 24-month split-mouth, randomized, and controlled study. J Dent. 2014 Feb;42(2):149-57. doi: 10.1016/j.jdent.2013.11.015. Epub 2013 Dec 1.
PubMed 24296163
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05606874
- Acronym / sponsor ID
- preheated flowable composite
- Conditions
- Pit and Fissure Sealant
- Keywords
- preheated flowable composite, pit and fissure sealant, Retention Rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Nov 2022 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 7 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-heating of flowable resin composite . | Experimental | Other: Pre-heating of flowable resin composite used as a pit and fissure sealant.(Filtek™ Z350Xt Flowable Restorative, 3M ESPSE, USA) |
| Conventional resin fissure sealant | Active comparator | Other: Conventional resin fissure sealant(total etch), (UltraSeal XT®, Ultradent, USA) |
Who may qualify
- Ages
- 16 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-heating of flowable resin composite used as a pit and fissure sealant.Also: (Filtek™ Z350Xt Flowable Restorative, 3M ESPSE, USA)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 | Pre-heating of flowable resin composite . |
| Conventional resin fissure sealantAlso: (total etch), (UltraSeal XT®, Ultradent, USA)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 | Conventional resin fissure sealant |
Primary outcome
Retention rate
Time frame: T1: 3 months
Retention criteria
Retention rate
Time frame: T2: 6 months
Retention criteria
Retention rate
Time frame: T3: 12 months
Retention criteria
3 secondary outcomes
Caries incidence
Time frame: T1: 3 months
Caries incidence
Time frame: T2: 6 months
Caries incidence
Time frame: T3: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Background: PubMed 18782377Featherstone JD. Dental caries: a dynamic disease process. Aust Dent J. 2008 Sep;53(3):286-91. doi: 10.1111/j.1834-7819.2008.00064.x.
- Background: PubMed 27900529Erbas Unverdi G, Atac SA, Cehreli ZC. Effectiveness of pit and fissure sealants bonded with different adhesive systems: a prospective randomized controlled trial. Clin Oral Investig. 2017 Sep;21(7):2235-2243. doi: 10.1007/s00784-016-2016-8. Epub 2016 Nov 30.
- Background: PubMed 18923223Subramaniam P, Konde S, Mandanna DK. Retention of a resin-based sealant and a glass ionomer used as a fissure sealant: a comparative clinical study. J Indian Soc Pedod Prev Dent. 2008 Sep;26(3):114-20. doi: 10.4103/0970-4388.43192.
- Background: PubMed 21779058Rickman LJ, Padipatvuthikul P, Chee B. Clinical applications of preheated hybrid resin composite. Br Dent J. 2011 Jul 22;211(2):63-7. doi: 10.1038/sj.bdj.2011.571.
- Background: PubMed 33005790Ramesh H, Ashok R, Rajan M, Balaji L, Ganesh A. Retention of pit and fissure sealants versus flowable composites in permanent teeth: A systematic review. Heliyon. 2020 Sep 24;6(9):e04964. doi: 10.1016/j.heliyon.2020.e04964. eCollection 2020 Sep.
- Background: PubMed 29988227Nahvi A, Razavian A, Abedi H, Charati JY. A comparison of microleakage in self-etch fissure sealants and conventional fissure sealants with total-etch or self-etch adhesive systems. Eur J Dent. 2018 Apr-Jun;12(2):242-246. doi: 10.4103/ejd.ejd_63_18.
- Background: PubMed 33083851Lopes LCP, Terada RSS, Tsuzuki FM, Giannini M, Hirata R. Heating and preheating of dental restorative materials-a systematic review. Clin Oral Investig. 2020 Dec;24(12):4225-4235. doi: 10.1007/s00784-020-03637-2. Epub 2020 Oct 20.
- Background: PubMed 28024165Khare M, Suprabha BS, Shenoy R, Rao A. Evaluation of pit-and-fissure sealants placed with four different bonding protocols: a randomized clinical trial. Int J Paediatr Dent. 2017 Nov;27(6):444-453. doi: 10.1111/ipd.12281. Epub 2016 Dec 26.
- Background: PubMed 31995416Kim HJ, Choi HJ, Kim KY, Kim KM. Effect of Heat and Sonic Vibration on Penetration of a Flowable Resin Composite Used as a Pit and Fissure Sealant. J Clin Pediatr Dent. 2020;44(1):41-46. doi: 10.17796/1053-4625-44.1.7.
- Background: PubMed 21998768Jafarzadeh M, Malekafzali B, Tadayon N, Fallahi S. Retention of a Flowable Composite Resin in Comparison to a Conventional Resin-Based Sealant: One-year Follow-up. J Dent (Tehran). 2010 Winter;7(1):1-5. Epub 2010 Mar 31.
- Background: PubMed 11203831Irinoda Y, Matsumura Y, Kito H, Nakano T, Toyama T, Nakagaki H, Tsuchiya T. Effect of sealant viscosity on the penetration of resin into etched human enamel. Oper Dent. 2000 Jul-Aug;25(4):274-82.
- Background: PubMed 17486182Ganesh M, Shobha T. Comparative evaluation of the marginal sealing ability of Fuji VII and Concise as pit and fissure sealants. J Contemp Dent Pract. 2007 May 1;8(4):10-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eman Abouauf, Ass.prof study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-heating of flowable resin composite used as a pit and fissure sealant. and Conventional resin fissure sealant in people with Pit and Fissure Sealant, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention rate (time frame: T1: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05606874, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.