Dental CariesNCT03342066
Reproducibility of Interactive Cariogram Software Versus Manual Caries Risk Assessment Form
An observational study of Dental Caries, run by Cairo University at 1 site in Egypt.
Trial summary
Reproducibility of Interactive Cariogram Software versus Manual Caries Risk Assessment Form on Clinician Decision: observational study Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- reproducability of caries risk assessment
- How many people
- 47 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2018to 10 Feb 2019
- Phase
- Observational
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: patients of both sex ,age from 18-40 with different oral hygiene and different dental condition but with good periodontal condition and no multiple extraction
Who may be able to join
- Patients should be in range of 18-40 years old. Patient should have good periodontal health
Who cannot join
- Patient below 18 years and above 40 years old Patient with periodontally affected teeth and mobility. Patient with multiple extraction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reproducibility of Interactive Cariogram Software Versus Manual Caries Risk Assessment Form on Clinician Decision: Observational Study
Reproducibility of Interactive Cariogram Software versus Manual Caries Risk Assessment Form on Clinician Decision: observational study
Read the detailed description
A main factor for planning any preventive program is to accurately assess a person's risk of developing a caries. Dental caries is a multifactorial disease and is affected by several factors, such as the patient's general health and diet, the amount and type of bacteria present in the oral cavity, salivary factors and exposure to fluoride.
Thus, caries risk assessment approaches should take into account risk implications from various factors that influence carious activity Many caries risk assessment models had been developed to assess the caries for certain individual, this study will be carried out to measure the reproducibility between CAMBRA and cariogram model to evaluate if one of them is enough to be used as they give the same result or not
- Conditions
- Dental Caries
- Being tested
- reproducability of caries risk assessment
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reproducability of caries risk assessmentDiagnostic test
reproducability of caries risk assessment CAMBRA verses cariogram
| Study group | Role | What they receive |
|---|---|---|
| A | Cariogram Receives: Diagnostic Test: reproducability of caries risk assessment | |
| B | CAMBRA Receives: Diagnostic Test: reproducability of caries risk assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducability "degree of matching between cariogram and cambra
reproducability of cariogram and cambra
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start1 Mar 2018
- Primary completion10 Feb 2019
- Study completion10 Feb 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Gamal ashour, Cairo University
- Investigators
- Mohamed farid, prof.Dr, Study director, Professor, Conservative Dentistry Department, Faculty of dentistry, Cairo University, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342066
- Sponsor's protocol ID
- gsda.1986
- Status last verified
- Feb 2019
- First submitted
- 6 Nov 2017
- Last updated
- 12 Feb 2019
- 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 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility of Interactive Cariogram Software Versus Manual Caries Risk Assessment Form on Clinician Decision: Observational Study
- ClinicalTrials.gov ID
- NCT03342066
- Acronym / sponsor ID
- gsda.1986
- Conditions
- Dental Caries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 10 Feb 2019 (actual)
- Study completion
- 10 Feb 2019 (actual)
- First posted
- 14 Nov 2017 (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.
Reproducibility of Interactive Cariogram Software versus Manual Caries Risk Assessment Form on Clinician Decision: observational study
Detailed description
A main factor for planning any preventive program is to accurately assess a person's risk of developing a caries. Dental caries is a multifactorial disease and is affected by several factors, such as the patient's general health and diet, the amount and type of bacteria present in the oral cavity, salivary factors and exposure to fluoride.
Thus, caries risk assessment approaches should take into account risk implications from various factors that influence carious activity Many caries risk assessment models had been developed to assess the caries for certain individual, this study will be carried out to measure the reproducibility between CAMBRA and cariogram model to evaluate if one of them is enough to be used as they give the same result or not
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Diagnostic Test: reproducability of caries risk assessmentCariogram |
| B | – | Diagnostic Test: reproducability of caries risk assessmentCAMBRA |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- patients of both sex ,age from 18-40 with different oral hygiene and different dental condition but with good periodontal condition and no multiple extraction
Key inclusion criteria (1 listed)
- Patients should be in range of 18-40 years old. Patient should have good periodontal health
Key exclusion criteria (1 listed)
- Patient below 18 years and above 40 years old Patient with periodontally affected teeth and mobility. Patient with multiple extraction
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 |
|---|---|---|
| reproducability of caries risk assessmentreproducability of caries risk assessment CAMBRA verses cariogram | Diagnostic test | A, B |
Primary outcome
Reproducability "degree of matching between cariogram and cambra
Time frame: one day
reproducability of cariogram and cambra
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 12 Feb 2019.
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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.
Mohamed farid, prof.Dr study director
Professor, Conservative Dentistry Department, Faculty of dentistry, Cairo University, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 1 inclusion and 1 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 12 Feb 2019. 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?
Reproducability "degree of matching between cariogram and cambra (time frame: one day). 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 12 Feb 2019.