Dental CariesNCT03668093
Evaluation of CAMBRA Versus ICCMS Caries Risk Assessment Models Acquisition On Treatment Plan
A study testing ICCM and CAMBRA in people with Dental Caries, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 17 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- ICCM and CAMBRA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2018to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of CAMBRA Versus ICCMS Caries Risk Assessment Models Acquisition On Treatment Plan In Young Adult Population
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)
Read the 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
- Being tested
- ICCM, CAMBRA
- Keywords
- caries prevention, caries management
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICCMOther
comprehensive system for caries management
CAMBRAOther
Caries risk assessment model
| Study group | Role | What they receive |
|---|---|---|
| ICCMS | Experimental | Intervention Receives: Other: CAMBRA |
| CAMBRA | Active comparator | Comparator Receives: Other: ICCM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start1 Nov 2018
- Primary completion1 Nov 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yomna sayed khallaf, Cairo University
- Investigators
- Yomna Khallaf, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668093
- Sponsor's protocol ID
- CEBD-CU-2018-09-07
- Status last verified
- Mar 2020
- First submitted
- 8 Sep 2018
- Last updated
- 4 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of CAMBRA Versus ICCMS Caries Risk Assessment Models Acquisition On Treatment Plan In Young Adult Population
- ClinicalTrials.gov ID
- NCT03668093
- Acronym / sponsor ID
- CEBD-CU-2018-09-07
- Conditions
- Dental Caries
- Keywords
- caries prevention, caries management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICCMS | Experimental | Other: CAMBRAIntervention |
| CAMBRA | Active comparator | Other: ICCMComparator |
Who may qualify
- Ages
- 17 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICCMcomprehensive system for caries management | Other | CAMBRA |
| CAMBRACaries risk assessment model | Other | ICCMS |
Primary outcome
new carious lesions
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yomna Khallaf, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICCM and CAMBRA in people with Dental Caries, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
new carious lesions (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.