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

Dental Caries Clinical Trial

— CAMBRA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01142440
• Other study ID #: IDF-918-2010
• Status: Recruiting
• Phase: Phase 4
• First received: June 10, 2010
• Last updated: June 28, 2011
• Start date: June 2010
• Est. completion date: March 2012

Study information

• Verified date: June 2011
• Source: Medical Corps, Israel Defense Force
• Contact: Einav Hirschhorn, DMD
• Phone: 972-57-8182218
• Email: ariel_hirschhorn_77[@]hotmail.com
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical 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 function as a control group. Each participant will be monitored for a period of 18 months.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: March 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Informed consent

Exclusion Criteria:

• Pregnancy

• Available for 18 month follow-up

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Caries

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

Locations

Country	Name	City	State
Israel	Israeli Defence Force	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Medical Corps, Israel Defense Force

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in one of the risk factors (such as eating habits, saliva, plaque control, fluorides).		6 months	No
Secondary	Progression of the disease in 30% of patients in the control group in comparison to only 15% in the intervention group.		18 months	No