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Effect of Tailored Preventive Program on Caires Incidence Using International Caries Classification and Management System (ICCMS) A Randomized Clinical Trial

Primary Purpose

Dental Caries

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
tailored preventive program
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Dental student.
  • No malocclusion.
  • Medically free

Exclusion Criteria:

  • Compromised medical history.
  • Severe or active periodontal disease.
  • Heavy bruxism or a traumatic occlusion

Sites / Locations

  • Ahmed Mamdouh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

study group

control group

Arm Description

After defining the individual patient's likelihood risk status and the diagnosis for each lesion, ICCMS presents a management element to build a comprehensive patient care plan as follow: In the study group they were given a preventive program as homecare program including tooth brushing 2/day with a fluoride toothpaste( 5000 ppm F) following the instructions in addition to fluoride mouth rinse. For the clinical approach motivational engagement was done by discussing with patients how to improve oral health behavior including amount of sugar, fibrous food and junk food. This in addition to pits and fissures sealant, F- varnish 2 times /year. and application of fluoride varnish every 6 months and dietary intake interventions.

In the Control group participants assigned to the control condition will be advised to maintain their existing lifestyles. For ethical reasons, if the program shows its effectiveness, it will be made available to all groups at the end of the study.

Outcomes

Primary Outcome Measures

Incidence of dental caires
ICCMS caries index Before the dental educational program, an oral examination will be done for the patient. Examination will be done by using mouth mirror and probe in natural day light. The educational program and outcome assessment will be assessed by ICCMS three times (immediately, three and six months) as the follow: Score 0 Tooth surfaces show no evidence of visible caries (no or questionable change in enamel translucency). Score 1 First or distinct visual changes in enamel seen as a carious opacity or visible discolouration not consistent with clinical appearance of sound enamel and which show no evidence of surface breakdown or underlying dentine shadowing. Score 2 A white or brown spot lesion with Localised enamel breakdown, without visible dentine exposure. Extensive stage Score 3 A distinct cavity in opaque or discoloured enamel with visible dentine.
Incidence of dental caires
ICCMS caries index
Incidence of dental caires
ICCMS caries index
Incidence of dental caires
ICCMS caries index

Secondary Outcome Measures

Full Information

First Posted
June 12, 2017
Last Updated
February 18, 2019
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03189797
Brief Title
Effect of Tailored Preventive Program on Caires Incidence Using International Caries Classification and Management System (ICCMS) A Randomized Clinical Trial
Official Title
Effect of Tailored Preventive Program on Caires Incidence Using International Caries Classification and Management System (ICCMS) A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 30, 2017 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
July 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will be conducted to evaluate The Effect of tailored preventive program on caries incidence using International Caries Classification and Management System (ICCMS) at a follow up periods of 3 ,6 and 12 months.
Detailed Description
A total number of 144 high caries risk dental students were selected based on the applied caries risk assessment method (CAMBRA). In the study group they were given a preventive program as homecare program including tooth brushing 2/day with a fluoride toothpaste( 5000 ppm F) following the instructions in addition to fluoride mouth rinse. For the clinical approach motivational engagement was done by discussing with patients how to improve oral health behavior including amount of sugar, fibrous food and junk food. This in addition to pits and fissures sealant, F- varnish 2 times /year. Recalls up were done at 3, 6 and 12 months by recording the caries prevalence , application of fluoride varnish every 6 months and dietary intake interventions. In the Control group participants assigned to the control condition will be advised to maintain their existing lifestyles. For ethical reasons, if the program shows its effectiveness, it will be made available to all groups at the end of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A total number of 144 high caries risk dental students are selected based on the applied caries risk assessment method (CAMBRA). In the study group they are given a preventive program as homecare program including tooth brushing 2/day with a fluoride toothpaste( 5000 ppm F) in addition to fluoride mouth rinse. For the clinical approach motivational engagement isdone by discussing with patients how to improve oral health behavior including amount of sugar, fibrous food and junk food. This in addition to pits and fissures sealant, F- varnish 2 times /year.application of fluoride varnish every 6 months and dietary intake interventions. In the Control group participants assigned to the control condition will be advised to maintain their existing lifestyles. For ethical reasons, if the program shows its effectiveness, it will be made available to all groups at the end of the study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
After defining the individual patient's likelihood risk status and the diagnosis for each lesion, ICCMS presents a management element to build a comprehensive patient care plan as follow: In the study group they were given a preventive program as homecare program including tooth brushing 2/day with a fluoride toothpaste( 5000 ppm F) following the instructions in addition to fluoride mouth rinse. For the clinical approach motivational engagement was done by discussing with patients how to improve oral health behavior including amount of sugar, fibrous food and junk food. This in addition to pits and fissures sealant, F- varnish 2 times /year. and application of fluoride varnish every 6 months and dietary intake interventions.
Arm Title
control group
Arm Type
No Intervention
Arm Description
In the Control group participants assigned to the control condition will be advised to maintain their existing lifestyles. For ethical reasons, if the program shows its effectiveness, it will be made available to all groups at the end of the study.
Intervention Type
Other
Intervention Name(s)
tailored preventive program
Other Intervention Name(s)
preventive dental program
Intervention Description
In the study group they were given a preventive program as homecare program including tooth brushing 2/day with a fluoride toothpaste( 5000 ppm F) following the instructions in addition to fluoride mouth rinse. For the clinical approach motivational engagement was done by discussing with patients how to improve oral health behavior including amount of sugar, fibrous food and junk food. This in addition to pits and fissures sealant, F- varnish 2 times /year. and application of fluoride varnish every 6 months and dietary intake interventions.
Primary Outcome Measure Information:
Title
Incidence of dental caires
Description
ICCMS caries index Before the dental educational program, an oral examination will be done for the patient. Examination will be done by using mouth mirror and probe in natural day light. The educational program and outcome assessment will be assessed by ICCMS three times (immediately, three and six months) as the follow: Score 0 Tooth surfaces show no evidence of visible caries (no or questionable change in enamel translucency). Score 1 First or distinct visual changes in enamel seen as a carious opacity or visible discolouration not consistent with clinical appearance of sound enamel and which show no evidence of surface breakdown or underlying dentine shadowing. Score 2 A white or brown spot lesion with Localised enamel breakdown, without visible dentine exposure. Extensive stage Score 3 A distinct cavity in opaque or discoloured enamel with visible dentine.
Time Frame
baseline
Title
Incidence of dental caires
Description
ICCMS caries index
Time Frame
3 months
Title
Incidence of dental caires
Description
ICCMS caries index
Time Frame
6 months
Title
Incidence of dental caires
Description
ICCMS caries index
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Dental student. No malocclusion. Medically free Exclusion Criteria: Compromised medical history. Severe or active periodontal disease. Heavy bruxism or a traumatic occlusion
Facility Information:
Facility Name
Ahmed Mamdouh
City
Cairo
State/Province
Maadi
ZIP/Postal Code
12345
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22262548
Citation
Garcia RI, Sohn W. The paradigm shift to prevention and its relationship to dental education. J Dent Educ. 2012 Jan;76(1):36-45.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.ncbi.nlm.nih.gov/pubmed

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Effect of Tailored Preventive Program on Caires Incidence Using International Caries Classification and Management System (ICCMS) A Randomized Clinical Trial

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