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

June 28, 2011 updated by: Medical Corps, Israel Defense Force

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

Study Locations

  • Israel
      • Tel Hashomer, Israel
        • Recruiting
        • Israeli Defence Force
        • Principal Investigator:
          • Einav Hirschhorn, DMD

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

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent

Exclusion Criteria:

  • Pregnancy
  • Available for 18 month follow-up

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: behavioral intervention
Behavioral: 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
No Intervention: convention dental treatment
Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in one of the risk factors (such as eating habits, saliva, plaque control, fluorides).
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
18 months

Collaborators and Investigators

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

Sponsor

Medical Corps, Israel Defense Force

Investigators

  • Study Chair: erwin weiss, professor, Head, Department of Prosthodontics Hebrew University - Hadassah, Jerusalem

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

June 1, 2010

Primary Completion (Anticipated)

February 1, 2012

Study Completion (Anticipated)

March 1, 2012

Study Registration Dates

First Submitted

June 10, 2010

First Submitted That Met QC Criteria

June 10, 2010

First Posted (Estimate)

June 11, 2010

Study Record Updates

Last Update Posted (Estimate)

June 29, 2011

Last Update Submitted That Met QC Criteria

June 28, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDF-918-2010

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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