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

NCT03668093 | Completed

• 1 other identifier: CEBD-CU-2018-09-07
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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)

Conditions

Dental Caries

Keywords

caries prevention; caries management

Outcome Measures

Primary Outcomes (1)

• new carious lesions

  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).

  12 months

Study Arms (2)

ICCMS

EXPERIMENTAL

Intervention

Other: CAMBRA

CAMBRA

ACTIVE COMPARATOR

Comparator

Other: ICCM

Interventions

ICCM OTHER

comprehensive system for caries management

CAMBRA

CAMBRA OTHER

Caries risk assessment model

ICCMS

Eligibility Criteria

• Age: 17 Years - 22 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Yomna

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Yomna Khallaf, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: demonstrator

Study Record Dates

• First Submitted: September 8, 2018
• First Posted: September 12, 2018
• Study Start: November 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 4, 2020

Record last verified: 2020-03

Locations

EG (1)