NCT01142440

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

June 29, 2011

Status Verified

June 1, 2011

Enrollment Period

1.7 years

First QC Date

June 10, 2010

Last Update Submit

June 28, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (1)

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

    18 months

Study Arms (2)

behavioral intervention

EXPERIMENTAL
Behavioral: behavioral intervention

convention dental treatment

NO INTERVENTION
Behavioral: behavioral intervention

Interventions

* 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

behavioral interventionconvention dental treatment

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Informed consent

You may not qualify if:

  • Pregnancy
  • Available for 18 month follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Israeli Defence Force

Tel Litwinsky, Israel

RECRUITING

MeSH Terms

Conditions

Dental Caries

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • erwin weiss, professor

    Head, Department of Prosthodontics Hebrew University - Hadassah, Jerusalem

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 10, 2010

First Posted

June 11, 2010

Study Start

June 1, 2010

Primary Completion

February 1, 2012

Study Completion

March 1, 2012

Last Updated

June 29, 2011

Record last verified: 2011-06

Locations