Clinical Effectiveness of Embrace Wetbond and Clinpro as Pits and Fissure Sealants in Young Permanent Molars

NCT ID: NCT02933463

Last Updated: 2016-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Brief Summary

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This study is designed to clinically evaluate the retention and development of caries when using self-priming (Embrace wetbond) and conventional flowable composite (Clinpro) as pit and fissure sealant in young first permanent molars.

Detailed Description

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The aim of this study is designed to clinically evaluate the retention and development of caries when using self-priming (Embrace Wetbond) and conventional flowable composite (Clinpro) as pit and fissure sealant in young first permanent molars.

PICO:

P: children aged 6-9 years old with high caries risk.

I: Embrace Wetbond.

C: Clinpro seal.

O:

Primary outcome: Retention of sealant; Device of measurement: questionnaire; unit: binary.

Secondary outcome: Retention and development of caries; Device of measurement: Modified simonsen's criteria; Unit: scoring system (0-4) tactile and visual examination.

Conditions

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Caries

Keywords

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children with high caries risk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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embrace wetbond sealant

moisture tolerant resin based, have same properties of other sealant

Group Type EXPERIMENTAL

Embrace Wetbond

Intervention Type OTHER

not require an additional bonding agent hydrophilic, fluoride releasing

clinpro sealant

is a dental resin, with low viscosity , fluoride releasing with a unique patented color change.

Group Type ACTIVE_COMPARATOR

Clinpro sealant

Intervention Type OTHER

Interventions

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Embrace Wetbond

not require an additional bonding agent hydrophilic, fluoride releasing

Intervention Type OTHER

Clinpro sealant

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* children aged 6-9 years
* children with high caries risk
* cooperative children
* fully erupted first permanent molars

Exclusion Criteria

* children with hypoplastic teeth
* partially erupted
* uncooperative children
* children with carious molars.
Minimum Eligible Age

6 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Noha Abdullah agina

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mahmoud Hamdy, professor

Role: STUDY_DIRECTOR

Cairo University

Central Contacts

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Noha Abdullah Agina, bachelor

Role: CONTACT

Phone: 01008318352

Email: [email protected]

Randa Youssef, lecturer

Role: CONTACT

References

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Aleksejuniene J, Brondani MA, Pattanaporn K, Brukiene V. Best practices for dental sealants in community service-learning. J Dent Educ. 2010 Sep;74(9):951-60.

Reference Type BACKGROUND
PMID: 20837736 (View on PubMed)

Al-Jobair A. Scanning electron microscope analysis of sealant penetration and adaptation in contaminated fissures. J Indian Soc Pedod Prev Dent. 2013 Jul-Sep;31(3):169-74. doi: 10.4103/0970-4388.117970.

Reference Type BACKGROUND
PMID: 24021327 (View on PubMed)

Bhat PK, Konde S, Raj SN, Kumar NC. Moisture-tolerant resin-based sealant: A boon. Contemp Clin Dent. 2013 Jul;4(3):343-8. doi: 10.4103/0976-237X.118394.

Reference Type BACKGROUND
PMID: 24124301 (View on PubMed)

Bhatia MR, Patel AR, Shirol DD. Evaluation of two resin based fissure sealants: a comparative clinical study. J Indian Soc Pedod Prev Dent. 2012 Jul-Sep;30(3):227-30. doi: 10.4103/0970-4388.105015.

Reference Type BACKGROUND
PMID: 23263426 (View on PubMed)

Deery C, Fyffe HE, Nugent ZJ, Nuttall NM, Pitts NB. General dental practitioners diagnostic and treatment decisions related to fissure sealed surfaces. J Dent. 2000 Jul;28(5):313-8. doi: 10.1016/s0300-5712(00)00004-x.

Reference Type BACKGROUND
PMID: 10785296 (View on PubMed)

Kane B, Karren J, Garcia-Godoy C, Garcia-Godoy F. Sealant adaptation and penetration into occlusal fissures. Am J Dent. 2009 Apr;22(2):89-91.

Reference Type BACKGROUND
PMID: 19626971 (View on PubMed)

Morales-Chavez MC, Nualart-Grollmus ZC. Retention of a resin-based sealant and a glass ionomer used as a fissure sealant in children with special needs. J Clin Exp Dent. 2014 Dec 1;6(5):e551-5. doi: 10.4317/jced.51688. eCollection 2014 Dec.

Reference Type BACKGROUND
PMID: 25674325 (View on PubMed)

Rohr M, Makinson OF, Burrow MF. Pits and fissures: morphology. ASDC J Dent Child. 1991 Mar-Apr;58(2):97-103.

Reference Type BACKGROUND
PMID: 2050885 (View on PubMed)

Reddy VR, Chowdhary N, Mukunda KS, Kiran NK, Kavyarani BS, Pradeep MC. Retention of resin-based filled and unfilled pit and fissure sealants: A comparative clinical study. Contemp Clin Dent. 2015 Mar;6(Suppl 1):S18-23. doi: 10.4103/0976-237X.152932.

Reference Type BACKGROUND
PMID: 25821368 (View on PubMed)

Schlueter N, Klimek J, Ganss C. Efficacy of a moisture-tolerant material for fissure sealing: a prospective randomised clinical trial. Clin Oral Investig. 2013 Apr;17(3):711-6. doi: 10.1007/s00784-012-0740-2. Epub 2012 May 3.

Reference Type BACKGROUND
PMID: 22552593 (View on PubMed)

Khatri SG, Samuel SR, Acharya S, Patil S, Madan K. Retention of Moisture-tolerant and Conventional Resin-based Sealant in Six- to Nine-year-old Children. Pediatr Dent. 2015 Jul-Aug;37(4):366-70.

Reference Type BACKGROUND
PMID: 26314605 (View on PubMed)

Going RE, Loesche WJ, Grainger DA, Syed SA. The viability of microorganisms in carious lesions five years after covering with a fissure sealant. J Am Dent Assoc. 1978 Sep;97(3):455-62. doi: 10.14219/jada.archive.1978.0327.

Reference Type BACKGROUND
PMID: 279600 (View on PubMed)

Mitchell DA, Mitchell L. Oxford Handbook of Clinical Dentistry (4th edition). New York: Oxford University Press; 2005.

Reference Type BACKGROUND

Ratnaditya A, Kumar MG , Jogenddrra SS,et al. Clinical evaluation of retention in hydrophobic and hydrophilic pit and fissure sealants-A Two Year Follow-Up Study. Journal of young pharmacist.2015;7(3):171.

Reference Type BACKGROUND

Strassler HE and O'Donnell JP. A unique moisture tolerant resin based pit and fissure sealant.2008.

Reference Type BACKGROUND

Pinkham J, Casamassimo P. Pediatric Dentistry. Infancy through Adolescence. 4 th ed. New Delhi: Saunders; 2005.

Reference Type BACKGROUND

Welburg R, Duggal H and Hosey M (Eds). Paediatric dentistry: treatment of dental caries in the preschool child. (3rd ed), 138-41.OXFORD UNIVERSITY PRESS, 2005.

Reference Type BACKGROUND

Related Links

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Other Identifiers

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Nagina

Identifier Type: -

Identifier Source: org_study_id