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

Phase 4

• Conditions: Dental Caries
• Interventions: Behavioral: behavioral intervention

• Registration Number: NCT01142440
• Lead Sponsor: Medical Corps, Israel Defense Force

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.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-10
• Study First Submitted QC: 2010-06-10
• Study First Posted: 2010-06-11
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-28
• Last Update Posted: 2011-06-29
• Primary Completion: 2012-02
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Informed consent

Exclusion Criteria

• Pregnancy
• Available for 18 month follow-up

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
behavioral intervention	behavioral intervention	-
convention dental treatment	behavioral intervention	-

Primary Outcome Measures

Name	Time	Method
Improvement in one of the risk factors (such as eating habits, saliva, plaque control, fluorides).	6 months

Secondary Outcome Measures

Name	Time	Method
Progression of the disease in 30% of patients in the control group in comparison to only 15% in the intervention group.	18 months

Trial Locations

Locations (1)

Israeli Defence Force; 🇮🇱 Tel Hashomer, Israel