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

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT03668093

Collaborator

(none)

104

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Other: ICCM Other: CAMBRA	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2018

Actual Primary Completion Date :

Nov 1, 2019

Actual Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ICCMS Intervention	Other: CAMBRA Caries risk assessment model
Active Comparator: CAMBRA Comparator	Other: ICCM comprehensive system for caries management

Arm

Intervention/Treatment

Experimental: ICCMS

Intervention

Other: CAMBRA

Caries risk assessment model

Active Comparator: CAMBRA

Comparator

Other: ICCM

comprehensive system for caries management

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 22 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yomna	Cairo		Egypt

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Yomna Khallaf, MD, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

yomna sayed khallaf, demonstrator, Cairo University

ClinicalTrials.gov Identifier:

NCT03668093

Other Study ID Numbers:

CEBD-CU-2018-09-07

First Posted:

Sep 12, 2018

Last Update Posted:

Mar 4, 2020

Last Verified:

Mar 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by yomna sayed khallaf, demonstrator, Cairo University

caries prevention

caries management

Additional relevant MeSH terms:

Dental Caries

Study Results

No Results Posted as of Mar 4, 2020