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

Not Applicable

Completed

• Conditions: Dental Caries
• Interventions: Other: ICCM; Other: CAMBRA

• Registration Number: NCT03668093
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2018-09-08
• Study First Submitted QC: 2018-09-11
• Study First Posted: 2018-09-12
• Study Start: 2018-11-01
• Primary Completion: 2019-11-01
• Study Completion: 2019-12-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-03
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAMBRA	ICCM	Comparator
ICCMS	CAMBRA	Intervention

Primary Outcome Measures

Name	Time	Method
new carious lesions	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).

Trial Locations

Locations (1)

Yomna; 🇪🇬 Cairo, Egypt