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

Cairo University (CU) logo

Cairo University (CU)

Status

Completed

Conditions

Dental Caries

Treatments

Other: ICCM
Other: CAMBRA

Study type

Interventional

Funder types

Other

Identifiers

NCT03668093
CEBD-CU-2018-09-07

Details and patient eligibility

About

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)

Full 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.

Enrollment

104 patients

Sex

All

Ages

17 to 22 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

104 participants in 2 patient groups

ICCMS
Experimental group
Description:
Intervention
Treatment:
Other: CAMBRA
CAMBRA
Active Comparator group
Description:
Comparator
Treatment:
Other: ICCM

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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