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

NCT ID: NCT03189797

Last Updated: 2019-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-30

Study Completion Date

2018-07-31

Brief Summary

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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

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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.

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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study group

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.

Group Type EXPERIMENTAL

tailored preventive program

Intervention Type OTHER

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.

control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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tailored preventive program

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.

Intervention Type OTHER

Other Intervention Names

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preventive dental program

Eligibility Criteria

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Inclusion Criteria

* Dental student.
* No malocclusion.
* Medically free

Exclusion Criteria

* Compromised medical history.
* Severe or active periodontal disease.
* Heavy bruxism or a traumatic occlusion
Minimum Eligible Age

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mamdouh

Internal resident at operative department cairo university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ahmed Mamdouh

Cairo, Maadi, Egypt

Site Status

Countries

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Egypt

References

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Garcia RI, Sohn W. The paradigm shift to prevention and its relationship to dental education. J Dent Educ. 2012 Jan;76(1):36-45.

Reference Type RESULT
PMID: 22262548 (View on PubMed)

Study Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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CEBC-CU-2017-03-15

Identifier Type: -

Identifier Source: org_study_id

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