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

Medical Corps, Israel Defense Force

Status and phase: Unknown; Phase 4

Conditions: Dental Caries

Treatments: Behavioral: behavioral intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01142440

IDF-918-2010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Informed consent

Exclusion criteria

• Pregnancy
• Available for 18 month follow-up

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

behavioral intervention

Experimental group

Treatment:

Behavioral: behavioral intervention

convention dental treatment

No Intervention group

Treatment:

Behavioral: behavioral intervention