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

June 6, 2023 updated by: Dilip Prajapati, Kathmandu University School of Medical Sciences
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

377

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nepal
    • Bagmati
      • Kavre, Bagmati, Nepal, 45210
        • Kathmandu University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness and Retention of Pit and Fissure Sealants in Rural Setup: A School-based Clinical Trial in Nepal
Time Frame: one year
Effectiveness of pit and fissure sealant in permanent molars, change from baseline in retention of the sealant at six months
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of silver diamine fluoride in caries prevention and arrest: An observational rural school based study
Time Frame: one year
Rate of arrested dental caries on permanent first molars with SDF application within one year followup
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kathmandu University School of Medical Sciences

Collaborators

University Grants Commission

Investigators

  • Study Director: Dashrath Kafle, MDS, KUSMS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 10, 2023

Primary Completion (Estimated)

November 15, 2023

Study Completion (Estimated)

December 25, 2023

Study Registration Dates

First Submitted

May 29, 2023

First Submitted That Met QC Criteria

June 6, 2023

First Posted (Actual)

June 8, 2023

Study Record Updates

Last Update Posted (Actual)

June 8, 2023

Last Update Submitted That Met QC Criteria

June 6, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 66/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

if needed , will share IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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