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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Medical Corps, Israel Defense Force.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical Corps, Israel Defense Force
ClinicalTrials.gov Identifier:
NCT01142440
First received: June 10, 2010
Last updated: June 28, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Dental Caries
Behavioral: behavioral intervention
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dental Caries Management by Risk Assessment: Identification and Treatment of Risk Factors Among Israeli Defence Force (IDF) Personnel

Resource links provided by NLM:


Further study details as provided by Medical Corps, Israel Defense Force:

Primary Outcome Measures:
  • Improvement in one of the risk factors (such as eating habits, saliva, plaque control, fluorides). [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: June 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Informed consent

Exclusion Criteria:

  • Pregnancy
  • Available for 18 month follow-up
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01142440

Contacts
Contact: Einav Hirschhorn, DMD 972-57-8182218 ariel_hirschhorn_77@hotmail.com

Locations
Israel
Israeli Defence Force Recruiting
Tel Hashomer, Israel
Principal Investigator: Einav Hirschhorn, DMD         
Sponsors and Collaborators
Medical Corps, Israel Defense Force
Investigators
Study Chair: erwin weiss, professor Head, Department of Prosthodontics Hebrew University - Hadassah, Jerusalem
  More Information

No publications provided

Responsible Party: Einav Hirschhorn, DMD, Medical Corps, Israel Defense Force
ClinicalTrials.gov Identifier: NCT01142440     History of Changes
Other Study ID Numbers: IDF-918-2010
Study First Received: June 10, 2010
Last Updated: June 28, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 20, 2014