Periodontal DiseasesNCT06290414
The Accuracy of Infrared Thermographic Imaging for Assessment of Periodontal Status
An observational study of Periodontal Diseases, run by Ain Shams University at 1 site in Egypt.
Trial summary
The diagnosis and differentiation between periodontal diseases are currently based on the measuring and interpretation of full-mouth clinical and radiographic criteria. Thermography is a modern non-invasive imaging method in which the infrared radiation emitted by an object allows the mapping and analysis of the exact… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- infrared thermal camera
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Nov 2023to 30 Nov 2024
- How long will I take part?
- 1 Day
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: A total of 45 of consecutive patients attending the periodontology outpatient clinic Patients will be selected according to the previously mentioned inclusion and exclusion criteria to be examined clinically and thermographically then they will be clustered into 3 clusters gingivitis , periodontitis and healthy patients based on the clinical diagnosis and each cluster will consist of 15 patients .
Who may be able to join
- The patients will be enrolled into the study based on the following inclusion criteria:
- Patients with generalized gingivitis
- patient with generalized periodontitis .
- patient with healthy periodontium .
- Both genders above 18 y to 60 y .
Who cannot join
- The patients will not be enrolled into this study based on the following exclusion criteria:
- pregnant women .
- smokers .
- Patients on medications that cause xerostomia as diuretics , antidepressants
- ,bronchodilators ,antihistaminics , antiepileptic ( etc ..)
- Patient using antibiotic, anti-inflammatory, and immunosuppressive therapy during the during the study .
Show all 9Show fewer
- molars according to camera specifications
- handicapped patients
- para functional habits as mouth breathing and tongue thrusting
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of dentistry Ain Shams University
Cairo
Shrouk N. Elboray, BDS, +201065433857, shrouk.elboraay@dent.asu.edu.eg
Mahetab M. AbdalWahab, lecturer, +201115554490, mahetabmohamed@dent.asu.edu.eg
About this study
Official title: The Accuracy of Infrared Thermographic Imaging for Assessment of Periodontal Status (A Cross-Sectional Study )
The diagnosis and differentiation between periodontal diseases are currently based on the measuring and interpretation of full-mouth clinical and radiographic criteria. Thermography is a modern non-invasive imaging method in which the infrared radiation emitted by an object allows the mapping and analysis of the exact temperature distribution on the surface of the object. The produced thermal images correlate with variations in local blood supply and tissue metabolism. Thus, suggested to be a useful rapid and non-invasive tool for the diagnosis of periodontal diseases. However, the validity of this tool compared to standard tools should be evaluated.
Read the detailed description
A total of 45 of consecutive patients attending the periodontology outpatient clinic will be examined using standard periodontal clinical parameters including; Plaque index (PI), Gingival index (GI), Probing depth (PD), Clinical attachment level (CAL), and standardized periapical radiograph, to identify patients with gingivitis, periodontitis, or healthy periodontium , these 45 patients will be clustered into 3 clusters consisting of 15 patients each to represent each category. The same patients will be examined using an infrared thermal camera (Fluke PTi120 Pocket Thermal Imager), the settings will be all according to the standards of infrared medical diagnosis then the acquired images will be analyzed with (Fluke SmartView IR Analysis Reporting Software and Mobile Application). The images will be interpreted to detect the temperature changes in each mm in tissues in order to determine the patients with gingivitis, periodontitis, or healthy periodontium by an investigator blinded to clinical diagnosis. Then the diagnostic sensitivity and specificity of thermographic images for diagnosis of periodontal diseases will be calculated
- Conditions
- Periodontal Diseases
- Being tested
- infrared thermal camera
- Keywords
- thermography, thermal changes, periodontal disease
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infrared thermal cameraDiagnostic test
capturing thermographic imaging of gingiva to detect thermal changes due to inflammation as a result of periodontal disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the agreement of thermographic images for diagnosis of periodontal diseases
Determine the agreement of thermographic images for diagnosis of periodontal diseases through the following outcomes:
- Sensitivity The proportion of true positives in diseased subjects= True positives/ (true positives + false negatives)
- Specificity The proportion of true negatives in non-diseased subjects= True negatives/ (true negatives + false positives).
Measured: 1 day
Secondary outcomes (1)
The temperature ranges for healthy periodontium, gingivitis and periodontitis
The temperature ranges for healthy periodontium, and for gingivitis, as well as, for periodontitis will be evaluated.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start30 Nov 2023
- Primary completion31 Oct 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shrouk Nabil, Ain Shams University
- Investigators
- Ola M. Ezzatt, professor, Study director, faculty of dentistry - Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290414
- Sponsor's protocol ID
- FDASU-Rec IM 112318
- Status last verified
- Aug 2024
- First submitted
- 25 Feb 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elboray SN, Ezzatt OM, Salah A, Mohamed A, Abdalwahab MM. Evaluation of the Accuracy of Infrared Thermographic Imaging for the Diagnosis of Periodontal Diseases: A Cross-Sectional Study. J Clin Periodontol. 2026 Apr;53(4):498-507. doi: 10.1111/jcpe.70066. Epub 2025 Dec 29.
PubMed 41457916
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of Infrared Thermographic Imaging for Assessment of Periodontal Status (A Cross-Sectional Study )
- ClinicalTrials.gov ID
- NCT06290414
- Acronym / sponsor ID
- FDASU-Rec IM 112318
- Conditions
- Periodontal Diseases
- Keywords
- thermography, thermal changes, periodontal disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 4 Mar 2024 (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.
The diagnosis and differentiation between periodontal diseases are currently based on the measuring and interpretation of full-mouth clinical and radiographic criteria. Thermography is a modern non-invasive imaging method in which the infrared radiation emitted by an object allows the mapping and analysis of the exact temperature distribution on the surface of the object. The produced thermal images correlate with variations in local blood supply and tissue metabolism. Thus, suggested to be a useful rapid and non-invasive tool for the diagnosis of periodontal diseases. However, the validity of this tool compared to standard tools should be evaluated.
Detailed description
A total of 45 of consecutive patients attending the periodontology outpatient clinic will be examined using standard periodontal clinical parameters including; Plaque index (PI), Gingival index (GI), Probing depth (PD), Clinical attachment level (CAL), and standardized periapical radiograph, to identify patients with gingivitis, periodontitis, or healthy periodontium , these 45 patients will be clustered into 3 clusters consisting of 15 patients each to represent each category. The same patients will be examined using an infrared thermal camera (Fluke PTi120 Pocket Thermal Imager), the settings will be all according to the standards of infrared medical diagnosis then the acquired images will be analyzed with (Fluke SmartView IR Analysis Reporting Software and Mobile Application). The images will be interpreted to detect the temperature changes in each mm in tissues in order to determine the patients with gingivitis, periodontitis, or healthy periodontium by an investigator blinded to clinical diagnosis. Then the diagnostic sensitivity and specificity of thermographic images for diagnosis of periodontal diseases will be calculated
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A total of 45 of consecutive patients attending the periodontology outpatient clinic Patients will be selected according to the previously mentioned inclusion and exclusion criteria to be examined clinically and thermographically then they will be clustered into 3 clusters gingivitis , periodontitis and healthy patients based on the clinical diagnosis and each cluster will consist of 15 patients .
Key inclusion criteria (5 listed)
- The patients will be enrolled into the study based on the following inclusion criteria:
Key exclusion criteria (9 listed)
- The patients will not be enrolled into this study based on the following exclusion criteria:
- ,bronchodilators ,antihistaminics , antiepileptic ( etc ..)
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 |
|---|---|---|
| infrared thermal cameracapturing thermographic imaging of gingiva to detect thermal changes due to inflammation as a result of periodontal disease | Diagnostic test | – |
Primary outcome
Determine the agreement of thermographic images for diagnosis of periodontal diseases
Time frame: 1 day
Determine the agreement of thermographic images for diagnosis of periodontal diseases through the following outcomes: * Sensitivity The proportion of true positives in diseased subjects= True positives/ (true positives + false negatives) * Specificity The proportion of true negatives in non-diseased subjects= True negatives/ (true negatives + false positives).
1 secondary outcome
The temperature ranges for healthy periodontium, gingivitis and periodontitis
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Derived from this study: PubMed 41457916Elboray SN, Ezzatt OM, Salah A, Mohamed A, Abdalwahab MM. Evaluation of the Accuracy of Infrared Thermographic Imaging for the Diagnosis of Periodontal Diseases: A Cross-Sectional Study. J Clin Periodontol. 2026 Apr;53(4):498-507. doi: 10.1111/jcpe.70066. Epub 2025 Dec 29.
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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.
Ola M. Ezzatt, professor study director
faculty of dentistry - Ain Shams University
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 Periodontal Diseases, run by Ain Shams 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 5 inclusion and 9 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 14 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shrouk N. Elboray, BDS (+0201065433857, shrouk.elboraay@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the agreement of thermographic images for diagnosis of periodontal diseases (time frame: 1 day). 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 NCT06290414, which also lists 1 linked publication.
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 14 Aug 2024.