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Evaluation of CAMBRA Versus ICCMS Caries Risk Assessment Models Acquisition On Treatment Plan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03668093
Recruitment Status : Completed
First Posted : September 12, 2018
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
yomna sayed khallaf, Cairo University

Study Description
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Brief Summary:
randomized clinical study to evaluate 'caries management by risk assessment' Versus 'international caries classification and management system' Caries Risk Assessment Models Acquisition On Treatment Plan In Young Adult Population with null hypothesis that International Caries Classification and Management System (ICCMS™) will have the same clinical performance as Caries management by risk assessment (CAMBRA)

Condition or disease Intervention/treatment Phase
Dental Caries Other: ICCM Other: CAMBRA Not Applicable

Detailed Description:

. (ICCMS™) Comprehensive Patient Care Pathway considered as significant development from the traditional system of treatment plan. Comprehensive patient care should include all recent information related to the biological, social, behavioral, cultural, systemic, and dental/oral risk factors which help development and progression of dental caries. (ICCMS™) also report all essential decisions that aid to preserve tooth structure; as diagnosis, prevention and restoration only if indicated [9]. Moreover ( ICCMS™) deals with caries as a disease and not as a lesion, prevent development of initial caries lesions, and restore moderate or extensive caries lesions with the aim of preserving of tooth structure as much as possible.

Follow up period is selected to be 12 months, since risk category is changed for better or worse over 1-2 year.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of CAMBRA Versus ICCMS Caries Risk Assessment Models Acquisition On Treatment Plan In Young Adult Population
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : November 1, 2019
Actual Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arms and Interventions
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Arm Intervention/treatment
Experimental: ICCMS
Intervention
 Other: CAMBRA
Caries risk assessment model
Active Comparator: CAMBRA
Comparator
 Other: ICCM
comprehensive system for caries management


Outcome Measures
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Primary Outcome Measures :
  1. new carious lesions [ Time Frame: 12 months ]

    Primary outcome :-New carious lesions Measuring device:- Visual-Tactile & Digital radiograph "Digora" Measuring unit :- Scoring system (ordinal)

    (ICDASTM code 0) Sound surfaces

    Initial stage caries (ICDASTM codes 1 and 2) First or distinct visual changes in enamel seen as a carious opacity or visible discolouration Moderate stage caries (ICDASTM codes 3 and 4) A white or brown spot lesion with Localised enamel breakdown, without visible dentine exposure (ICDASTM code 3), or an Underlying dentine shadow (ICDASTM code 4) Extensive stage caries (ICDASTM codes 5 and 6) A distinct cavity in opaque or discoloured enamel with visible dentine (ICDASTM code 5 or 6).



Eligibility Criteria
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Ages Eligible for Study:   17 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • New patients
  • Able to give informed consent in Arabic
  • Unlikely to move from the area within 1y for work educational, or personal reasons (determined by residential history and questioning);
  • Willing to participate regardless of group assignment
  • Willing to comply with all study procedures and protocol
  • ≥16 permanent teeth

Exclusion Criteria:

  • Patient not willing to have dental radiographs taken
  • Patient with significant past or current medical conditions that might affect oral health or oral flora (i.e., diabetes, human immunodeficiency virus, heart conditions requiring antibiotic prophylaxis)
  • Patient with medication use that might affect the oral flora or salivary flow (e.g., antibiotic use in the past 3 months, drugs associated with dry mouth/xerostomia)
  • Patient with root caries at enrollment
  • Patient with periodontal disease requiring surgery, chemotherapeutic agents, or frequent prophylaxis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668093


Locations
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Egypt
Yomna
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Yomna Khallaf, MD Cairo University
More Information
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Responsible Party: yomna sayed khallaf, demonstrator, Cairo University
ClinicalTrials.gov Identifier: NCT03668093    
Other Study ID Numbers: CEBD-CU-2018-09-07
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by yomna sayed khallaf, Cairo University:
caries prevention
caries management
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases