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

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT03189797

Collaborator

(none)

144

Enrollment

Location

Arms

Actual Duration (Months)

11.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Other: tailored preventive program	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

144 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 30, 2017

Actual Primary Completion Date :

Sep 30, 2017

Actual Study Completion Date :

Jul 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: 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. Other Names: preventive dental program
No Intervention: 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.

Arm

Intervention/Treatment

Experimental: 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.

Other: 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.

Other Names:

preventive dental program

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

Incidence of dental caires [baseline]
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 [3 months]
ICCMS caries index
Incidence of dental caires [6 months]
ICCMS caries index
Incidence of dental caires [12 months]
ICCMS caries index

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 24 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmed Mamdouh	Cairo	Maadi	Egypt	12345

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Mamdouh, Internal resident at operative department cairo university, Cairo University

ClinicalTrials.gov Identifier:

NCT03189797

Other Study ID Numbers:

CEBC-CU-2017-03-15

First Posted:

Jun 16, 2017

Last Update Posted:

Feb 20, 2019

Last Verified:

Feb 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dental Caries

Study Results

No Results Posted as of Feb 20, 2019