Dental Caries Pit and FissureNCT05894200
Effectiveness and Retention of Pit and Fissure Sealants in Rural Setup: A School-based Clinical Trial in Nepal
An observational study of Dental Caries Pit and Fissure and Oral Disease, run by Kathmandu University School of Medical Sciences at 1 site in Nepal.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Dental Caries Pit and Fissure, Oral Disease
- What is being tested?
- Glass Ionomer cement pit and fissure sealant, Silver Diamine Fluoride
- How many people
- 377 participants
- Where
- 1 siteNepal
- Study dates
- 10 Aug 2023to 25 Dec 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- Child
Study population: Purposive sampling technique used among school children from Him Ganga secondary School, Shangutar, Ramechhap , Nepal
Who may be able to join
- All the students from the school who is willing to participate in this study aged between 6-15 years old
Who cannot join
- Students who is not willing to participate or not permitted from parents
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Dental Caries Pit and Fissure, Oral Disease
- Being tested
- Glass Ionomer cement pit and fissure sealant, Silver Diamine Fluoride
- Keywords
- Nepal, Oral health, Dental
- Medical subject headings
- Mouth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glass Ionomer cement pit and fissure sealant, Silver Diamine FluorideOther
GC Fuji 7, e-SDF
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start10 Aug 2023 (estimated)
- Primary completion15 Nov 2023 (estimated)
- Study completion25 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dental Caries Pit and FissureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 377 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Kathmandu University School of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University Grants Commission
- Responsible party
- Principal investigator, Dilip Prajapati, Kathmandu University School of Medical Sciences
- Investigators
- Dashrath Kafle, MDS, Study director, KUSMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894200
- Sponsor's protocol ID
- 66/23
- Status last verified
- Jun 2023
- First submitted
- 29 May 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: if needed , will share IPD
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 18310730Alkhodairi 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 32165964Bridge 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Retention of Pit and Fissure Sealants in Rural Setup: A School-based Clinical Trial in Nepal
- ClinicalTrials.gov ID
- NCT05894200
- Acronym / sponsor ID
- 66/23
- Conditions
- Dental Caries Pit and Fissure, Oral Disease
- Keywords
- Nepal, Oral health, Dental
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 377 participants (estimated)
- Lead sponsor
- Kathmandu University School of Medical SciencesUniversity, hospital or other
- Collaborators
- University Grants Commission
- Study start
- 10 Aug 2023 (estimated)
- Primary completion
- 15 Nov 2023 (estimated)
- Study completion
- 25 Dec 2023 (estimated)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Age groups
- Child
- Study population
- Purposive sampling technique used among school children from Him Ganga secondary School, Shangutar, Ramechhap , Nepal
Key inclusion criteria (1 listed)
- All the students from the school who is willing to participate in this study aged between 6-15 years old
Key exclusion criteria (1 listed)
- Students who is not willing to participate or not permitted from parents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glass Ionomer cement pit and fissure sealant, Silver Diamine FluorideGC Fuji 7, e-SDF | Other | – |
Primary outcome
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
1 secondary outcome
Effectiveness of silver diamine fluoride in caries prevention and arrest: An observational rural school based study
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Results publication: PubMed 18310730Beauchamp 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.
- Results publication: PubMed 32165964Alkhodairi 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.
- Results publication: PubMed 33653594Bridge 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.
- Central bureau of statistic, Government of Nepal Census 2021Link provided by the sponsor.
- World Health organization. Oralhealth survey fifth editionLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. if needed , will share IPD
Related trials for Dental Caries Pit and Fissure
Not yet recruiting
Clinical Evaluation of the Retention of Fissure Sealants Applied Following Guided Biofilm Therapy and Conventional Polishing
Pit and Fissure Sealant Retention, Dental Caries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dashrath Kafle, MDS study director
KUSMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries Pit and Fissure and Oral Disease, run by Kathmandu University School of Medical Sciences at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness and Retention of Pit and Fissure Sealants in Rural Setup: A School-based Clinical Trial in Nepal (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05894200, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.