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Status unknownNCT02933463Updated Nov 1, 2016

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

An interventional study of Embrace Wetbond and Clinpro sealant in Caries, sponsored by Cairo University. Status unknown. Open to participants aged 6 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-01.

Sponsored by Cairo University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Oct 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
6 Years to 9 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Caries

Keywords

  • children with high caries risk
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • children with hypoplastic teeth
  • partially erupted
  • uncooperative children
  • children with carious molars.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    embrace wetbond sealant

    moisture tolerant resin based, have same properties of other sealant

    Other: Embrace Wetbond

  • Active comparator
    clinpro sealant

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

    Other: Clinpro sealant

Interventions

  • OtherEmbrace Wetbond

    not require an additional bonding agent hydrophilic, fluoride releasing

  • OtherClinpro sealant
06

What researchers measure

Primary outcomes

  1. Retention of sealant

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

    Time frame: 6 months

Secondary outcomes

  1. Retention and development of caries

    device of measurement: simonsen's criteria, unit of measurement: scoring system from 0-4 by tactile and visual examination.

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 20837736 ↗
  • 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. PubMed 24021327 ↗
  • 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. PubMed 24124301 ↗
  • 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. PubMed 23263426 ↗
  • 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. PubMed 10785296 ↗
  • 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. PubMed 19626971 ↗
  • 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. PubMed 25674325 ↗
  • Rohr M, Makinson OF, Burrow MF. Pits and fissures: morphology. ASDC J Dent Child. 1991 Mar-Apr;58(2):97-103. PubMed 2050885 ↗
  • 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. PubMed 25821368 ↗
  • 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. PubMed 22552593 ↗
  • 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. PubMed 26314605 ↗
  • 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. PubMed 279600 ↗
  • Mitchell DA, Mitchell L. Oxford Handbook of Clinical Dentistry (4th edition). New York: Oxford University Press; 2005.
  • 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.
  • Strassler HE and O'Donnell JP. A unique moisture tolerant resin based pit and fissure sealant.2008.
  • Pinkham J, Casamassimo P. Pediatric Dentistry. Infancy through Adolescence. 4 th ed. New Delhi: Saunders; 2005.
  • 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.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02933463
Lead sponsor
Cairo University
Responsible party
Noha Abdullah agina (Principal Investigator, Cairo University) — Principal investigator
First posted
Oct 14, 2016
Start date
Oct 2016
Primary completion
Aug 2017 (estimated)
Last update
Nov 1, 2016

Study contacts

Noha Abdullah Agina, bachelor
Contact
noha-abdullah@dentistry.cu.edu.eg
01008318352
Randa Youssef, lecturer
Contact
Mahmoud Hamdy, professor
study director · Cairo University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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