NCT02933463

Brief Summary

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 14, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

10 months

First QC Date

October 11, 2016

Last Update Submit

October 31, 2016

Conditions

Caries

Keywords

children with high caries risk

Outcome Measures

Primary Outcomes (1)

  • Retention of sealant

    device for measurement: will make a questionnaire for the patients , unit of measurement: binary ( yes/no)

    6 months

Secondary Outcomes (1)

  • Retention and development of caries

    6 months

Study Arms (2)

embrace wetbond sealant

EXPERIMENTAL

moisture tolerant resin based, have same properties of other sealant

Other: Embrace Wetbond

clinpro sealant

ACTIVE COMPARATOR

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

Other: Clinpro sealant

Interventions

Embrace WetbondOTHER

not require an additional bonding agent hydrophilic, fluoride releasing

embrace wetbond sealant
Clinpro sealantOTHER
clinpro sealant

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • children with hypoplastic teeth
  • partially erupted
  • uncooperative children
  • children with carious molars.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (17)

  • 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.

    PMID: 20837736BACKGROUND

  • 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.

    PMID: 24021327BACKGROUND

  • 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.

    PMID: 24124301BACKGROUND

  • 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.

    PMID: 23263426BACKGROUND

  • 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.

    PMID: 10785296BACKGROUND

  • 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.

    PMID: 19626971BACKGROUND

  • 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.

    PMID: 25674325BACKGROUND

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

    PMID: 2050885BACKGROUND

  • 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.

    PMID: 25821368BACKGROUND

  • 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.

    PMID: 22552593BACKGROUND

  • 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.

    PMID: 26314605BACKGROUND

  • 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.

    PMID: 279600BACKGROUND

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

    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.

    BACKGROUND

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

    BACKGROUND

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

    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.

    BACKGROUND

Related Links

MeSH Terms

Interventions

Embrace WetBondClinpro Sealant

Study Officials

  • Mahmoud Hamdy, professor

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Noha Abdullah Agina, bachelor

CONTACT

01008318352noha-abdullah@dentistry.cu.edu.eg

Randa Youssef, lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 11, 2016

First Posted

October 14, 2016

Study Start

October 1, 2016

Primary Completion

August 1, 2017

Last Updated

November 1, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share