CClinicalTrials.gg
Status unknownNCT01142440CAMBRAUpdated Jun 29, 2011

Dental Caries Management by Risk Assessment: Identification and Treatment of Risk Factors Among (IDF) Personnel

A Phase 4 interventional study of behavioral intervention in Dental Caries, sponsored by Medical Corps, Israel Defense Force. Status unknown at 1 site in Israel. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-29.

Sponsored by Medical Corps, Israel Defense Force · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Dental Caries

Browse trials for

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 400 is above the median of 60 across 916 interventional studies indexed under Dental Caries.

Browse Dental Caries studies →

Lead sponsor

Medical Corps, Israel Defense Force is the lead sponsor of 33 studies on the registry; 3 are open to participants now.

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

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Informed consent

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Available for 18 month follow-up
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    behavioral intervention

    Behavioral: behavioral intervention

  • No intervention
    convention dental treatment

    Behavioral: behavioral intervention

Interventions

  • Behavioralbehavioral 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

06

What researchers measure

Primary outcomes

  1. Improvement in one of the risk factors (such as eating habits, saliva, plaque control, fluorides).

    Time frame: 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.

    Time frame: 18 months

07

Study locations

1 of 1 sites recruiting
  • Israeli Defence Force
    Tel Hashomer, Israel
    • Einav Hirschhorn, DMD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01142440
Lead sponsor
Medical Corps, Israel Defense Force
First posted
Jun 11, 2010
Start date
Jun 2010
Primary completion
Feb 2012 (estimated)
Completion
Mar 2012 (estimated)
Last update
Jun 29, 2011

Study contacts

Einav Hirschhorn, DMD
Contact
ariel_hirschhorn_77@hotmail.com
972-57-8182218
erwin weiss, professor
study chair · Head, Department of Prosthodontics Hebrew University - Hadassah, Jerusalem

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion