Clinical trial NCT03668093: Evaluation of CAMBRA Versus ICCMS Caries Risk Assessment Models Acquisition On Treatment Plan
Official title: Evaluation of CAMBRA Versus ICCMS Caries Risk Assessment Models Acquisition On Treatment Plan In Young Adult Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: caries prevention
caries management
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 104
Sex: ALL
Minimum age (years): 17
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: new carious lesions
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Yomna
Study officials:
affiliation: Cairo University
name: Yomna Khallaf, MD
role: PRINCIPAL_INVESTIGATOR
References: