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Completed

NCT Number: NCT03668093

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

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)

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Key information

Age range

17 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yomna

Cairo, Egypt

About this study

. (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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICCM

Other

comprehensive system for caries management

CAMBRA

Other

Caries risk assessment model

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Evaluation of CAMBRA Versus ICCMS Caries Risk Assessment Models Acquisition On Treatment Plan In Young Adult Population

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 12, 2018
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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