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

NCT03189797 | Completed DMC

• 1 other identifier: CEBC-CU-2017-03-15
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (4)

• 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.

  baseline

• Incidence of dental caires

  ICCMS caries index

  3 months

• Incidence of dental caires

  ICCMS caries index

  6 months

• Incidence of dental caires

  ICCMS caries index

  12 months

Study Arms (2)

study group

EXPERIMENTAL

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

control group

NO INTERVENTION

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.

Interventions

tailored preventive program 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.

Also known as: preventive dental program

study group

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Dental student.
• No malocclusion.
• Medically free

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ahmed Mamdouh

Cairo, Maadi, 12345, Egypt

Location

Related Publications (1)

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

  PMID: 22262548 RESULT

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internal resident at operative department cairo university

Model Details: 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.

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 16, 2017
• Study Start: June 30, 2017
• Primary Completion: September 30, 2017
• Study Completion: July 31, 2018
• Last Updated: February 20, 2019

Record last verified: 2019-02

Locations

EG (1)