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

Primary Purpose

Dental Caries

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

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring caries prevention, caries management

Eligibility Criteria

17 Years - 22 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Yomna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ICCMS

CAMBRA

Arm Description

Intervention

Comparator

Outcomes

Primary Outcome Measures

new carious lesions
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).

Secondary Outcome Measures

Full Information

First Posted
September 8, 2018
Last Updated
March 3, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03668093
Brief Title
Evaluation of CAMBRA Versus ICCMS Caries Risk Assessment Models Acquisition On Treatment Plan
Official Title
Evaluation of CAMBRA Versus ICCMS Caries Risk Assessment Models Acquisition On Treatment Plan In Young Adult Population
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (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

5. Study Description

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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
caries prevention, caries management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICCMS
Arm Type
Experimental
Arm Description
Intervention
Arm Title
CAMBRA
Arm Type
Active Comparator
Arm Description
Comparator
Intervention Type
Other
Intervention Name(s)
ICCM
Intervention Description
comprehensive system for caries management
Intervention Type
Other
Intervention Name(s)
CAMBRA
Intervention Description
Caries risk assessment model
Primary Outcome Measure Information:
Title
new carious lesions
Description
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).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yomna Khallaf, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yomna
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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

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