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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03668093
Enrollment
104
Registered
2018-09-12
Start date
2018-11-01
Completion date
2019-12-01
Last updated
2020-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

Keywords

caries prevention, caries management

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.

Interventions

OTHERICCM

comprehensive system for caries management

OTHERCAMBRA

Caries risk assessment model

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
17 Years to 22 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
new carious lesions12 monthsPrimary 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).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026