Caries, DentalNCT02958891
Dental Health Epidemiology Among Israel Defense Forces (IDF) Recruits
An observational study of Caries, Dental and Gingivitis, run by Medical Corps, Israel Defense Force at 1 site in Israel.
Trial summary
An epidemiological survey for prevalence description of dental morbidity (caries, gingivitis, dental trauma and fluorosis) among Israel Defense Forces (IDF) general recruits. Morbidity measures were collected from 700 recruits at their first day of military service in order to evaluate extent and burden of dental… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caries, Dental, Gingivitis, Fluorosis
- What is being tested?
- Data collection
- How many people
- 700 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2016to Dec 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: General IDF recruits.
Who may be able to join
- Above 18 years old.
Who cannot join
- Chronic bone diseases.
- Mineralization defects
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Caries, Gingivitis, Dental Trauma and Fluorosis Prevalence Among IDF Recruits - an Epidemiological Survey
An epidemiological survey for prevalence description of dental morbidity (caries, gingivitis, dental trauma and fluorosis) among Israel Defense Forces (IDF) general recruits. Morbidity measures were collected from 700 recruits at their first day of military service in order to evaluate extent and burden of dental diseases among recruits. The data will enable the military dental services commanders to plan and implement dental services according to the dental needs.
Read the detailed description
Caries, gingivitis, dental trauma and fluorosis epidemiological measures were collected among IDF recruits in 700 sample using short clinical evaluation without radiographs. water fluoridation ecological data will be obtained from the ministry of health. the results might impact dental services plan, professional manpower system, and the layout of the dental clinics in the IDF. It will give the professionals in the military dental services an evidence based data for planning an accurate primary and secondary prevention programs and an evaluation of dental diseases burden in order to have the "full picture" of recruits dental needs. .
- Conditions
- Caries, Dental, Gingivitis, Fluorosis, Dental Trauma
- Being tested
- Data collection
- Medical subject headings
- Dental Caries, Gingivitis, Fluoride Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Collection epidemiological dental measures
What is being measured
The primary outcome is the main question the study is designed to answer.
DMFT index (Decayed, Missing, Filled, Tooth)
Measured: 7 days
CPI (Community Periodontal Index) index
Measured: 7 days
TDI (Dental Trauma Index) index
Measured: 7 days
TF (Thylstrup & Fejerskov Index for dental Fluorosis) index
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2016
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caries, DentalStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Corps, Israel Defense Force
- Sponsor type
- University, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Responsible party
- Principal investigator, Nirit Yavnai, Medical Corps, Israel Defense Force
- Investigators
- Nirit Yavnai, DMD MPH, Principal investigator, IDF Medical Corps
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958891
- Sponsor's protocol ID
- 1524-2015
- Status last verified
- Nov 2016
- First submitted
- 6 Nov 2016
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data will be published after statistical analysis only.
Publications
Yavnai N, Mazor S, Vered Y, Shavit I, Zini A. Caries prevalence among 18 years old, an epidemiological survey in Israel. Isr J Health Policy Res. 2020 Aug 31;9(1):45. doi: 10.1186/s13584-020-00402-4.
PubMed 32867853
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caries, Gingivitis, Dental Trauma and Fluorosis Prevalence Among IDF Recruits - an Epidemiological Survey
- ClinicalTrials.gov ID
- NCT02958891
- Acronym / sponsor ID
- 1524-2015
- Conditions
- Caries, Dental, Gingivitis, Fluorosis, Dental Trauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Medical Corps, Israel Defense ForceUniversity, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Study start
- Mar 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 8 Nov 2016 (estimated)
- 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.
An epidemiological survey for prevalence description of dental morbidity (caries, gingivitis, dental trauma and fluorosis) among Israel Defense Forces (IDF) general recruits. Morbidity measures were collected from 700 recruits at their first day of military service in order to evaluate extent and burden of dental diseases among recruits. The data will enable the military dental services commanders to plan and implement dental services according to the dental needs.
Detailed description
Caries, gingivitis, dental trauma and fluorosis epidemiological measures were collected among IDF recruits in 700 sample using short clinical evaluation without radiographs. water fluoridation ecological data will be obtained from the ministry of health. the results might impact dental services plan, professional manpower system, and the layout of the dental clinics in the IDF. It will give the professionals in the military dental services an evidence based data for planning an accurate primary and secondary prevention programs and an evaluation of dental diseases burden in order to have the "full picture" of recruits dental needs. .
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- General IDF recruits.
Key inclusion criteria (1 listed)
- Above 18 years old.
Key exclusion criteria (2 listed)
- Chronic bone diseases.
- Mineralization defects
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 |
|---|---|---|
| Data collectionCollection epidemiological dental measures | Other | – |
Primary outcome
DMFT index (Decayed, Missing, Filled, Tooth)
Time frame: 7 days
CPI (Community Periodontal Index) index
Time frame: 7 days
TDI (Dental Trauma Index) index
Time frame: 7 days
TF (Thylstrup & Fejerskov Index for dental Fluorosis) index
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- Derived from this study: PubMed 32867853Yavnai N, Mazor S, Vered Y, Shavit I, Zini A. Caries prevalence among 18 years old, an epidemiological survey in Israel. Isr J Health Policy Res. 2020 Aug 31;9(1):45. doi: 10.1186/s13584-020-00402-4.
- Individual participant dataSharing planned: No. Data will be published after statistical analysis only.
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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.
Nirit Yavnai, DMD MPH principal investigator
IDF Medical Corps
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 Caries, Dental and Gingivitis, run by Medical Corps, Israel Defense Force at 1 site in Israel.
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 2 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 15 Nov 2016. 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 Israel. 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?
DMFT index (Decayed, Missing, Filled, Tooth) (time frame: 7 days). The study lists 4 primary outcomes in all. 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 NCT02958891, which also lists 1 linked publication.
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 15 Nov 2016.