Dental CariesPhase 4CAMBRANCT01142440
Dental Caries Management by Risk Assessment: Identification and Treatment of Risk Factors Among (IDF) Personnel
A Phase 4 study testing behavioral intervention in people with Dental Caries, run by Medical Corps, Israel Defense Force at 1 site in Israel.
Trial summary
Our study is designed as an interventional prospective longitudinal study which examines the Israeli defense force personnel. The population of our study is composed out of the IDF personnel which will be randomly be subdivided into 2 different groups - one will be noted as the intervention group and the other will… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- behavioral intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2010to Mar 2012
- Phase
- Phase 4
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent
Who cannot join
- Pregnancy
- Available for 18 month follow-up
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Israeli Defence Force
Tel HaShomer
Einav Hirschhorn, DMD
About this study
Official title: Dental Caries Management by Risk Assessment: Identification and Treatment of Risk Factors Among Israeli Defence Force (IDF) Personnel
Our study is designed as an interventional prospective longitudinal study which examines the Israeli defense force personnel. The population of our study is composed out of the IDF personnel which will be randomly be subdivided into 2 different groups - one will be noted as the intervention group and the other will function as a control group. Each participant will be monitored for a period of 18 months.
Read the detailed description
On the intervention group, which includes a couple of hundreds participants, a thorough caries management by risk assessment plan will be conducted. The risk assessment will include the following criteria:
- Saliva check
- Plaque control
- Plaque acidity
- Diet - Frequency of carbohydrate intake
- Previous caries experience and present carious activity
- Others (prosthetic/orthodontic appliances, systemic diseases etc.)
After obtaining the data the patients will be categorized into 1 of 3 distinct risk level - low, medium, high. Each category will be treated according to a tailored treatment protocol:
- Dietary instructions
- Oral hygiene instructions
- Antibacterial therapy
- Fluorides
- Restoration
- Follow ups The control group will be treated according to standard protocol of treatment in the IDF dental clinics, which is based on removal the cavitated lesions, and lacks any reference to caries as a multifactorial infectious disease.
We assume that personalized treatment of the disease, based on identifying risk factors will lower the number of patients with active disease.
- Conditions
- Dental Caries
- Being tested
- behavioral intervention
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral interventionBehavioural
- Dietary instructions
- Oral hygiene instructions: GC plaque indicator kit
- Antibacterial therapy: medident sol. one week a month, for 6 months
- Fluorides: VOCO Profluorid varnish, once every 3 month
- Restoration
- Follow ups
| Study group | Role | What they receive |
|---|---|---|
| behavioral intervention | Experimental | Not described Receives: Behavioral: behavioral intervention |
| convention dental treatment | No intervention | Not described Receives: Behavioral: behavioral intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in one of the risk factors (such as eating habits, saliva, plaque control, fluorides).
Measured: 6 months
Secondary outcomes (1)
Progression of the disease in 30% of patients in the control group in comparison to only 15% in the intervention group.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionFeb 2012 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Corps, Israel Defense Force
- Sponsor type
- University, hospital or other
- Investigators
- erwin weiss, professor, Study chair, Head, Department of Prosthodontics Hebrew University - Hadassah, Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142440
- Sponsor's protocol ID
- IDF-918-2010
- Acronym
- CAMBRA
- Status last verified
- Jun 2011
- First submitted
- 10 Jun 2010
- Last updated
- 29 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dental Caries Management by Risk Assessment: Identification and Treatment of Risk Factors Among Israeli Defence Force (IDF) Personnel
- ClinicalTrials.gov ID
- NCT01142440
- Acronym / sponsor ID
- CAMBRA / IDF-918-2010
- Conditions
- Dental Caries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Medical Corps, Israel Defense ForceUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 11 Jun 2010 (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.
Our study is designed as an interventional prospective longitudinal study which examines the Israeli defense force personnel. The population of our study is composed out of the IDF personnel which will be randomly be subdivided into 2 different groups - one will be noted as the intervention group and the other will function as a control group. Each participant will be monitored for a period of 18 months.
Detailed description
On the intervention group, which includes a couple of hundreds participants, a thorough caries management by risk assessment plan will be conducted. The risk assessment will include the following criteria:
- Saliva check
- Plaque control
- Plaque acidity
- Diet - Frequency of carbohydrate intake
- Previous caries experience and present carious activity
- Others (prosthetic/orthodontic appliances, systemic diseases etc.)
After obtaining the data the patients will be categorized into 1 of 3 distinct risk level - low, medium, high. Each category will be treated according to a tailored treatment protocol:
- Dietary instructions
- Oral hygiene instructions
- Antibacterial therapy
- Fluorides
- Restoration
- Follow ups The control group will be treated according to standard protocol of treatment in the IDF dental clinics, which is based on removal the cavitated lesions, and lacks any reference to caries as a multifactorial infectious disease.
We assume that personalized treatment of the disease, based on identifying risk factors will lower the number of patients with active disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| behavioral intervention | Experimental | Behavioral: behavioral intervention |
| convention dental treatment | No intervention | Behavioral: behavioral intervention |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Informed consent
Key exclusion criteria (2 listed)
- Pregnancy
- Available for 18 month follow-up
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 |
|---|---|---|
| behavioral intervention* Dietary instructions * Oral hygiene instructions: GC plaque indicator kit * Antibacterial therapy: medident sol. one week a month, for 6 months * Fluorides: VOCO Profluorid varnish, once every 3 month * Restoration * Follow ups | Behavioural | behavioral intervention, convention dental treatment |
Primary outcome
Improvement in one of the risk factors (such as eating habits, saliva, plaque control, fluorides).
Time frame: 6 months
1 secondary outcome
Progression of the disease in 30% of patients in the control group in comparison to only 15% in the intervention group.
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2011.
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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.
erwin weiss, professor study chair
Head, Department of Prosthodontics Hebrew University - Hadassah, Jerusalem
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing behavioral intervention in people with Dental Caries, 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 29 Jun 2011. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Einav Hirschhorn, DMD (972-57-8182218, ariel_hirschhorn_77@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in one of the risk factors (such as eating habits, saliva, plaque control, fluorides). (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2011; AzTrials last refreshed its copy on 7 Nov 2026.