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Enrolling by invitationNCT05894200Updated Jun 8, 2023

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

An observational study in Dental Caries Pit and Fissure and Oral Disease, sponsored by Kathmandu University School of Medical Sciences. Enrolling by invitation at 1 site in Nepal. Open to participants aged 6 Years to 15 Years. Per ClinicalTrials.gov, last updated 2023-06-08.

Sponsored by Kathmandu University School of Medical Sciences · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2023, 2 years 10 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
377
Ages
6 Years to 15 Years
Sex
All
01

Study 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.

Read the detailed description

World Health Organization reported that untreated caries in permanent teeth is the most prevalent condition, affecting 3.5 billion people globally, which seems more aggressive in developing countries. Such untreated dental caries in permanent teeth is the most common health condition according to the global burden of disease 2019 which can be largely preventable and school based preventive program are the most effective one to overcome such problems. Acute or unplanned dental care accounted loss of 34 million school hours annually compared to children with very good oral health. Silver diamine fluoride is safe and effective alternative treatment for the children which can improve oral health outcomes for community members especially for individuals from low socioeconomic settings and can transform the concept of community dental caries program. pit and fissure sealants is very effective tool for caries prevention on an individual basis or as part of a public health measure for at - risk populations which can be applied both primary and secondary level of prevention. However in developing and underdeveloped countries, because of the lack of this preventive measure, every year children develop dental caries, pulpitis and ultimately extraction of permanent teeth which could otherwise be saved.

Methodology: Screening will be done in the school premises by the expert dentist from Kathmandu University School of Medical Science with sterilized Dental kit and head lamp taking universal precautions. Participants will be segregated according to class and respective class teachers will help them in screening accordingly. Both verbal and written consent will be taken from students, respective class teachers and parents if available.

World health organization, Oral Health Assessment form for Children, 2013 will be used to collect oral health data which includes demographic details, dentition status, gingival status, enamel fluorosis, Dental trauma, oral mucosal lesions, intervention urgency and dento-facial anomalies. After recording the data, Investigator will make a treatment plan and segregate the students according to the need for Silver diamine fluoride application, GIC pit and fissure sealant application or oral urgency treatment which will be coordinated by the available volunteers. All the students who participated in this study will be provided with fluoridated toothpaste and brush.

Pit and fissure sealant application: Deep pit and fissure will be identified and plaque removal is done with the toothbrush provided, conditioning will be done by conditioner liquid available with GIC pit and fissure sealant. Tooth surface will be cleaned with three-way syringe available in dental chair, Isolation will be maintained with cotton roll and sealant will be evaluated and occlusal bite will be registered. Students will be informed about post-restoration instructions in verbal and printed form of instruction will be given to individuals.

02

Conditions studied

  • Dental Caries Pit and Fissure
  • Oral Disease

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Keywords

  • Nepal
  • Oral health
  • Dental
03

In context

Dental Caries

1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.

This study's planned enrollment of 377 is above the median of 180 across 177 observational studies indexed under Dental Caries.

Browse Dental Caries studies →

Lead sponsor

Kathmandu University School of Medical Sciences is the lead sponsor of 27 studies on the registry; 12 are open to participants now.

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

04

Who can participate

Ages eligible
6 Years to 15 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Students who is not willing to participate or not permitted from parents
05

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
377 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Interventions

  • OtherGlass Ionomer cement pit and fissure sealant, Silver Diamine Fluoride

    GC Fuji 7, e-SDF

06

What researchers measure

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

    Time frame: one year

Secondary outcomes

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

    Rate of arrested dental caries on permanent first molars with SDF application within one year followup

    Time frame: one year

07

Study locations

1 site
  • Kathmandu University
    Kavre, Bagmati 45210, Nepal
08

References and documents

Publications

  • 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. PubMed 18310730 ↗
  • 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. PubMed 32165964 ↗
  • 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. PubMed 33653594 ↗

Individual participant data

Plan to share: Undecided — if needed , will share IPD

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05894200
Lead sponsor
Kathmandu University School of Medical Sciences
Collaborators
University Grants Commission
Responsible party
Dilip Prajapati (Assistant professor, Kathmandu University School of Medical Sciences) — Principal investigator
First posted
Jun 8, 2023
Start date
Aug 10, 2023 (estimated)
Primary completion
Nov 15, 2023 (estimated)
Completion
Dec 25, 2023 (estimated)
Last update
Jun 8, 2023

Study contacts

Dashrath Kafle, MDS
study director · KUSMS

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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