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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dental Caries

Intervention / Treatment
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* Behavioral: behavioral intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent Exclusion Criteria: Pregnancy Available for 18 month follow-up

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: behavioral intervention<br> | Behavioral: behavioral intervention<br>* 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<br>|
| No Intervention: convention dental treatment<br> | Behavioral: behavioral intervention<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of the disease in 30% of patients in the control group in comparison to only 15% in the intervention group. |  | 18 months |