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

Primary Purpose

Dental Caries

Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
behavioral intervention
Sponsored by
Medical Corps, Israel Defense Force
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Informed consent

Exclusion Criteria:

  • Pregnancy
  • Available for 18 month follow-up

Sites / Locations

  • Israeli Defence ForceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

behavioral intervention

convention dental treatment

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Progression of the disease in 30% of patients in the control group in comparison to only 15% in the intervention group.

Full Information

First Posted
June 10, 2010
Last Updated
June 28, 2011
Sponsor
Medical Corps, Israel Defense Force
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1. Study Identification

Unique Protocol Identification Number
NCT01142440
Brief Title
Dental Caries Management by Risk Assessment: Identification and Treatment of Risk Factors Among (IDF) Personnel
Acronym
CAMBRA
Official Title
Dental Caries Management by Risk Assessment: Identification and Treatment of Risk Factors Among Israeli Defence Force (IDF) Personnel
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
February 2012 (Anticipated)
Study Completion Date
March 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Medical Corps, Israel Defense Force

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
behavioral intervention
Arm Type
Experimental
Arm Title
convention dental treatment
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
behavioral intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Improvement in one of the risk factors (such as eating habits, saliva, plaque control, fluorides).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Informed consent Exclusion Criteria: Pregnancy Available for 18 month follow-up
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Einav Hirschhorn, DMD
Phone
972-57-8182218
Email
ariel_hirschhorn_77@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
erwin weiss, professor
Organizational Affiliation
Head, Department of Prosthodontics Hebrew University - Hadassah, Jerusalem
Official's Role
Study Chair
Facility Information:
Facility Name
Israeli Defence Force
City
Tel Hashomer
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Einav Hirschhorn, DMD

12. IPD Sharing Statement

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

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