Oral Soft Tissue ConditionsNCT03717389
The Prevalence of Soft Tissue Calcifications in the Head and Neck Region Using CBCT Among Egyptian Population
An observational study of Oral Soft Tissue Conditions, run by Maha Samy Elhadidy.
Trial summary
Prevalence of soft tissue calcifications in the head and neck region is not clearly studied in the Egyptian population. Determining the incidence of these calcifications can improve the knowledge of dental practitioners and allow such practitioners to initiate proper diagnostic. Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Oral Soft Tissue Conditions
- What is being tested?
- presence of soft tissue calcification in head and neck
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- Nov 2018to Jun 2020
- 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 10 to 80 years
- All sexes
- Child, Adult, Older adult
Study population: A total of 350 CBCT scans belonging to Egyptian individuals who had CBCT examination as part of their dental treatment planning during the years 2017-2018-2019.from the data base available at the Oral and Maxillofacial Radiology department at the faculty of dentistry -Cairo university
Who may be able to join
- CBCT scans of 0.2 mm Voxel size will be included
- Scans that clearly show mandible only; maxilla only; maxilla and mandible or whole face will be included.
- Patients age 10-80 years old .
Who cannot join
- • Images with (Field Of View) show only one tooth or teeth.
- Images of poor quality will be excluded.
- Images showing artifacts caused by metallic implants or osteosynthesis plates.
- Images subjected to patient movement during acquisition will be excluded also.
About this study
Official title: The Prevalence of Soft Tissue Calcifications in the Head and Neck Region Using CBCT Among Egyptian Population: Observational Cross Sectional Study
Prevalence of soft tissue calcifications in the head and neck region is not clearly studied in the Egyptian population.
Determining the incidence of these calcifications can improve the knowledge of dental practitioners and allow such practitioners to initiate proper diagnostic. And if patients need treatment they can start early by the right therapy to stop the.
The aim of this research is to detect and quantify the prevalence of the soft tissue calcifications by cone beam computed tomography (CBCT) images of the head and neck region in the Egyptian population.
Read the detailed description
Calcification of various structures located in the head and neck region are reported in patients seeking dental care.
Although most of the soft tissue calcification within the head and neck region might not be accompanied by clinical symptoms; the investigators should not assume that their detection do not has a strong clinical significance .
Some soft tissue calcification may suggest the presence of a systemic condition and may cause threatening consequences .
Understanding of the nature of soft tissue calcification in the head and neck helps in proper diagnosis of these calcification and in turn taking the right decision of asking for further investigation; referral or do nothing .
Also; many of the structures in the head and neck region are in close proximity to one another which makes identification and localization difficult and this may lead to false diagnosis .
CBCT is a valuable imaging modality to overcome this difficulty. The data collection for this study will be obtained from the data base available at the Oral and Maxillofacial Radiology department at the faculty of dentistry -Cairo university
The following information will be recorded for each patient by :
- Age of the patient at the time of the scan . 2. Sex (male or female). 3. Type of the scan (mandible only, maxilla and mandible, and full scan).
- Assessment will be made for the following;
- Presence or absence of calcification.
- Type of calcification present (or what is this soft tissue structure).
- Side (i.e. unilateral or bilateral and what side) .
- Single or multiple occurring.
- During assessing the CBCT images; neither clinical information nor demographic data of the patients will be available to any of the two radiologists.
- Then inter-observational and intra-observational variability between the observers will be evaluated.
- Conditions
- Oral Soft Tissue Conditions
- Being tested
- presence of soft tissue calcification in head and neck
- Keywords
- prevalence, soft tissue calcification in head and neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
presence of soft tissue calcification in head and neckOther
soft tissue calcifications of the head and neck region in the Egyptian population
What is being measured
The primary outcome is the main question the study is designed to answer.
what is percent of participants having soft tissue calcification among the whole population included"whether males or females"
percentage%
Measured: the participants will be assessed 2 times at 2 weeks interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study startNov 2018 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Oral Soft Tissue ConditionsStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maha Samy Elhadidy
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Maha Samy Elhadidy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717389
- Sponsor's protocol ID
- 2371987
- Status last verified
- Oct 2018
- First submitted
- 18 Oct 2018
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Khojastepour L, Haghnegahdar A, Sayar H. Prevalence of Soft Tissue Calcifications in CBCT Images of Mandibular Region. J Dent (Shiraz). 2017 Jun;18(2):88-94.
PubMed 28620632Caglayan F, Sumbullu MA, Miloglu O, Akgul HM. Are all soft tissue calcifications detected by cone-beam computed tomography in the submandibular region sialoliths? J Oral Maxillofac Surg. 2014 Aug;72(8):1531.e1-6. doi: 10.1016/j.joms.2014.04.005. Epub 2014 Apr 13.
PubMed 25037186Guarda-Nardini L, Piccotti F, Ferronato G, Manfredini D. Myositis ossificans traumatica of the temporalis muscle: a case report and diagnostic considerations. Oral Maxillofac Surg. 2012 Jun;16(2):221-5. doi: 10.1007/s10006-011-0293-6. Epub 2011 Sep 22.
PubMed 21938392Lewis DA, Brooks SL. Cartoid artery calcification in a general dental population: a retrospective study of panoramic radiographs. Gen Dent. 1999 Jan-Feb;47(1):98-103.
PubMed 10321159
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Soft Tissue Calcifications in the Head and Neck Region Using CBCT Among Egyptian Population: Observational Cross Sectional Study
- ClinicalTrials.gov ID
- NCT03717389
- Acronym / sponsor ID
- 2371987
- Conditions
- Oral Soft Tissue Conditions
- Keywords
- prevalence, soft tissue calcification in head and neck
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Maha Samy ElhadidyUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- Nov 2018 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 24 Oct 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.
Prevalence of soft tissue calcifications in the head and neck region is not clearly studied in the Egyptian population.
Determining the incidence of these calcifications can improve the knowledge of dental practitioners and allow such practitioners to initiate proper diagnostic. And if patients need treatment they can start early by the right therapy to stop the.
The aim of this research is to detect and quantify the prevalence of the soft tissue calcifications by cone beam computed tomography (CBCT) images of the head and neck region in the Egyptian population.
Detailed description
Calcification of various structures located in the head and neck region are reported in patients seeking dental care.
Although most of the soft tissue calcification within the head and neck region might not be accompanied by clinical symptoms; the investigators should not assume that their detection do not has a strong clinical significance .
Some soft tissue calcification may suggest the presence of a systemic condition and may cause threatening consequences .
Understanding of the nature of soft tissue calcification in the head and neck helps in proper diagnosis of these calcification and in turn taking the right decision of asking for further investigation; referral or do nothing .
Also; many of the structures in the head and neck region are in close proximity to one another which makes identification and localization difficult and this may lead to false diagnosis .
CBCT is a valuable imaging modality to overcome this difficulty. The data collection for this study will be obtained from the data base available at the Oral and Maxillofacial Radiology department at the faculty of dentistry -Cairo university
The following information will be recorded for each patient by :
- Age of the patient at the time of the scan . 2. Sex (male or female). 3. Type of the scan (mandible only, maxilla and mandible, and full scan).
- Assessment will be made for the following;
- Presence or absence of calcification.
- Type of calcification present (or what is this soft tissue structure).
- Side (i.e. unilateral or bilateral and what side) .
- Single or multiple occurring.
- During assessing the CBCT images; neither clinical information nor demographic data of the patients will be available to any of the two radiologists.
- Then inter-observational and intra-observational variability between the observers will be evaluated.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 350 CBCT scans belonging to Egyptian individuals who had CBCT examination as part of their dental treatment planning during the years 2017-2018-2019.from the data base available at the Oral and Maxillofacial Radiology department at the faculty of dentistry -Cairo university
Key inclusion criteria (3 listed)
- CBCT scans of 0.2 mm Voxel size will be included
- Scans that clearly show mandible only; maxilla only; maxilla and mandible or whole face will be included.
- Patients age 10-80 years old .
Key exclusion criteria (4 listed)
- • Images with (Field Of View) show only one tooth or teeth.
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 |
|---|---|---|
| presence of soft tissue calcification in head and necksoft tissue calcifications of the head and neck region in the Egyptian population | Other | – |
Primary outcome
what is percent of participants having soft tissue calcification among the whole population included"whether males or females"
Time frame: the participants will be assessed 2 times at 2 weeks interval
percentage%
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Background: PubMed 28620632Khojastepour L, Haghnegahdar A, Sayar H. Prevalence of Soft Tissue Calcifications in CBCT Images of Mandibular Region. J Dent (Shiraz). 2017 Jun;18(2):88-94.
- Background: PubMed 25037186Caglayan F, Sumbullu MA, Miloglu O, Akgul HM. Are all soft tissue calcifications detected by cone-beam computed tomography in the submandibular region sialoliths? J Oral Maxillofac Surg. 2014 Aug;72(8):1531.e1-6. doi: 10.1016/j.joms.2014.04.005. Epub 2014 Apr 13.
- Background: PubMed 21938392Guarda-Nardini L, Piccotti F, Ferronato G, Manfredini D. Myositis ossificans traumatica of the temporalis muscle: a case report and diagnostic considerations. Oral Maxillofac Surg. 2012 Jun;16(2):221-5. doi: 10.1007/s10006-011-0293-6. Epub 2011 Sep 22.
- Background: PubMed 10321159Lewis DA, Brooks SL. Cartoid artery calcification in a general dental population: a retrospective study of panoramic radiographs. Gen Dent. 1999 Jan-Feb;47(1):98-103.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Soft Tissue Conditions, run by Maha Samy Elhadidy.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
what is percent of participants having soft tissue calcification among the whole population included"whether males or females" (time frame: the participants will be assessed 2 times at 2 weeks interval). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03717389, which also lists 4 linked publications.
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 24 Oct 2018.