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

Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02933463
• Other study ID #: Nagina
• Status: Not yet recruiting
• Phase: N/A
• First received: October 11, 2016
• Last updated: October 31, 2016
• Start date: October 2016

Study information

• Verified date: October 2016
• Source: Cairo University
• Contact: Noha Abdullah Agina, bachelor
• Phone: 01008318352
• Email: noha-abdullah[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 9 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Caries

Intervention

Other:
• Embrace Wetbond
not require an additional bonding agent hydrophilic, fluoride releasing
• Clinpro sealant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (17)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Morales-Chávez 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. — View Citation

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

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. — View Citation

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

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. — View Citation

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

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.

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention of sealant	device for measurement: will make a questionnaire for the patients , unit of measurement: binary ( yes/no)	6 months	No
Secondary	Retention and development of caries	device of measurement: simonsen's criteria, unit of measurement: scoring system from 0-4 by tactile and visual examination.	6 months	No

External Links

•   Link
•   Link