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

NCT ID: NCT03668093

Last Updated: 2020-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2019-12-01

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.

Conditions

Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ICCMS

Intervention

Group Type: EXPERIMENTAL

CAMBRA

Intervention Type: OTHER

Caries risk assessment model

CAMBRA

Comparator

Group Type: ACTIVE_COMPARATOR

ICCM

Intervention Type: OTHER

comprehensive system for caries management

Interventions

ICCM

comprehensive system for caries management

Intervention Type: OTHER

CAMBRA

Caries risk assessment model

Intervention Type: OTHER

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

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

yomna sayed khallaf

demonstrator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yomna Khallaf, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Yomna

Cairo, , Egypt

Countries

Egypt

Other Identifiers

CEBD-CU-2018-09-07

Identifier Type: -

Identifier Source: org_study_id