Effectiveness and Retention of Pit and Fissure Sealants in Rural Setup: A School-based Clinical Trial in Nepal

NCT05894200 | Unknown DMC

• 1 other identifier: 66/23
• Study Type: observational
• Target: 377
• Locations: 1 country
• Sites: 1

Brief Summary

The program titled "Campus to Community: breaking the barrier in oral health education and dental care" is uniquely designed program to link University (Kathmandu University School of Medical Sciences) to community (Sanghutar, Ramechhap). Dhulikhel Hospital, Kathmandu University Teaching Hospital has established a model dental clinic in the premises of Him Ganga Secondary School, Shangutar which is operated by council registered Dentist and dental hygienist. The objective of this study is to assess oral health condition of the children aged 6-15 years of the school followed by application of pit and fissure sealant (PFS) in non-carious permanent molar and Silver diamine fluoride (SDF) in carious permanent teeth. Data will be recorded according to the WHO Oral health assessment form for children, 2013 by a calibrated dentist from Dhulikhel Hospital and retention of PFS and efficacy of SDF application will be followed up after 6 months by the same investigators. The program is proposed with the expectation that proper oral hygiene prevention program combined with preventive procedures like pit and fissure sealant and SDF can reduce the burden of oral diseases in rural setup.

Conditions

Dental Caries Pit and Fissure; Oral Disease

Keywords

Nepal; Oral health; Dental

Outcome Measures

Primary Outcomes (1)

• Effectiveness and Retention of Pit and Fissure Sealants in Rural Setup: A School-based Clinical Trial in Nepal

  Effectiveness of pit and fissure sealant in permanent molars, change from baseline in retention of the sealant at six months

  one year

Secondary Outcomes (1)

• Effectiveness of silver diamine fluoride in caries prevention and arrest: An observational rural school based study

  one year

Interventions

Glass Ionomer cement pit and fissure sealant, Silver Diamine Fluoride OTHER

GC Fuji 7, e-SDF

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Purposive sampling technique used among school children from Him Ganga secondary School, Shangutar, Ramechhap , Nepal

You may qualify if:

• All the students from the school who is willing to participate in this study aged between 6-15 years old

You may not qualify if:

• Students who is not willing to participate or not permitted from parents

Sponsors & Collaborators

• Kathmandu University School of Medical Sciences: lead
• University Grants Commission: collaborator

Study Sites (1)

Kathmandu University

Kavre, Bagmati, 45210, Nepal

Location

Related Publications (3)

• Beauchamp J, Caufield PW, Crall JJ, Donly K, Feigal R, Gooch B, Ismail A, Kohn W, Siegal M, Simonsen R; American Dental Association Council on Scientific Affairs. Evidence-based clinical recommendations for the use of pit-and-fissure sealants: a report of the American Dental Association Council on Scientific Affairs. J Am Dent Assoc. 2008 Mar;139(3):257-68. doi: 10.14219/jada.archive.2008.0155.

  PMID: 18310730 RESULT

• Alkhodairi A, Alseweed M, Alwashmi S, Elmoazen RA. Clinical Evaluation of the Retention of Resin and Glass Ionomer Sealants Applied as a Part of School-Based Caries Prevention Program. Open Access Maced J Med Sci. 2019 Dec 13;7(23):4127-4130. doi: 10.3889/oamjms.2019.869. eCollection 2019 Dec 15.

  PMID: 32165964 RESULT

• Bridge G, Martel AS, Lomazzi M. Silver Diamine Fluoride: Transforming Community Dental Caries Program. Int Dent J. 2021 Dec;71(6):458-461. doi: 10.1016/j.identj.2020.12.017. Epub 2021 Feb 27.

  PMID: 33653594 RESULT

Related Links

• Central bureau of statistic, Government of Nepal Census 2021
• World Health organization. Oralhealth survey fifth edition

MeSH Terms

Conditions

Mouth Diseases

Interventions

Pit and Fissure Sealants; silver diamine fluoride

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Dashrath Kafle, MDS

  KUSMS

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: June 8, 2023
• Study Start: August 10, 2023
• Primary Completion: November 15, 2023
• Study Completion: December 25, 2023
• Last Updated: June 8, 2023

Record last verified: 2023-06

Locations

NE (1)