GingivitisNCT04326413
Artificial Intelligence Evaluation of Periodontal Health Using Selfie Intraoral Photography
An observational study of Gingivitis, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Periodontal (gum) disease affecting more than 90% of the population globally. The soft and hard tissues that supporting the teeth are being affected. If untreated, the disease progresses from the mild and reversible form (i.e. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Oral hygiene instruction and simple scaling
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2023to 24 Mar 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy dentate patients with gingivitis only and have 24 or more teeth
Who may be able to join
- Adult subjects attending PPDH and are able to give informed consent
- Subjects who diagnosed to have gingivitis only and have 24 or more teeth
- Subjects who are otherwise medically health
- Subjects who are able to attend multiple dental visits
Who cannot join
- Subjects who are in acute dental infection or in pain
- Subjects who have oral mucosal diseases that preclude retraction of soft tissues for photos
- Subjects who are in fixed appliance for orthodontic treatment
- Subjects who are pregnancy, or medically unfit for periodontal charting or requires antibiotic coverage (e.g. risk of infective endocarditis)
Trial locations and contacts
1 site in 1 country.
About this study
Periodontal (gum) disease affecting more than 90% of the population globally. The soft and hard tissues that supporting the teeth are being affected. If untreated, the disease progresses from the mild and reversible form (i.e. gingivitis) that involves superficial gum only to the more severe and irreversible form (i.e. periodontitis) that involves loss of periodontal ligament and bone. Teeth will be lost eventually and significantly impairs the function and the oral health related quality of health. Moreover, periodontal disease has been strongly linked to the systemic diseases via centrally or local routes with significant health implications.
Periodontal disease is initiated by bacteria (plaque) adhere on tooth surfaces and the body defense by eliciting inflammatory response. The disease and associated inflammation is site-specific and the affected gum is manifested with the cardinal signs of inflammation such as redness (color), swelling (increased volume), edema (loss of surface characteristics) and bleeds easily. Dentists are trained to identify the disease sites by visual (redness and swelling) and by mechanical probing (bleeding). Traditionally these give rises to clinical gum indices showing the degree of inflammation and are important to the clinical monitoring and management of gum diseases.
Read more
The management of periodontal disease involves the removal of bacteria plaque by both dentists' tooth cleaning and maintained by patients' daily home-care. Home-care plaque removal has been shown by many studies to prevent and/or cease the development of periodontitis. However, most patients do not able to remove plaque effectively and it only takes few days for a health site to development inflammation. Professional monitoring and feedback are highly desirable but many patients only have monthly or even yearly appointment which is too late. Such "non-compliance" increase the treatment cost/time, patient discomfort and reduce treatment efficacy. Moreover, many patients do not receive regular dental checkup and they seek dentists when the gum problem becomes irreversible that complicated and expensive treatment such as tooth extraction and rehabilitation is required.
This study consists of 1) collecting the standardized clinical photography with clinical gum indices/ marked by an experienced clinician, 2) import into computer for training, and 3) longitudinally monitoring and analyze of gum condition in a group of gingivitis patients receiving gum treatment.
Read the detailed description
The first part of this study will collect buccal view of intraoral photo and clinical gum indices from 300 patients visiting Prince Philip Dental Hospital (PPDH). These intraoral photo will be taken by patients using smartphone (iphone) mounted with apparatus (Scanbox) in a standardized way and the quality supervised by clinical staff. Clinical gum indices will be taken by a trained and calibrated clinical staff. Alternatively clinical photo may be assessed by an experienced clinician to locate the inflamed/health gum. This synthesized data set imported into neural network to learn the image characteristics of inflamed and health gum and train the computer.
The second part of this study will recruit 150 patients with gingivitis and longitudinally follow up their gum condition pre- and post- gum treatment in PPDH using standardized intraoral photo and clinical gum indices. The clinical gum indices are the gold standard reflecting the changes in the gum condition.
All photos collected would be analyzed by computer (software: MatLab) to identify key features that help with screening and monitoring of gum condition. Data would then be collected for building a program that quantifies the identified features which may include the following:
- Color of marginal gum tissues
- Texture of marginal gum tissues
- Volume of marginal gum tissues, with reference to the clinical gum indices.
Data and sample size analysis: The computer will be trained with the photo and clinical indices/assessment obtained in the part I of this study. The trained computer will then use to monitor changes of periodontal condition of patients in part II of this study based on photo only. The sensitivity (detect true disease), specificity (detect true health) and the area under these curves (with reference to the gold standard clinical gum indices) will be calculated and are the main outcome of this study. The training of computer is a continuous process and the endpoint comes when the sensitivity, specificity and the area under these curves (AUC) reach plateau (saturation). Therefore, the training of computer will be staged into three phrases with 100, 200 and 300 of cases in the part I of this study and observe the changes in the sensitivity, specificity and AUC.
Patient reported outcome on the use of smartphone selfie would be recorded in visual analogue scale (VAS) as secondary outcome.
Sample size determination: Each tooth represents one unit and assume each subject has 20 teeth, there will be more than 300 subjects X 20 teeth =6000 units for training. For the part 2 study, 150 subjects will be recruited and 130X20=2600 units for testing of the computer.
All new patients attending Prince Philip Dental Hospital will be screen for gum inflammation and periodontal diseases by clinical examination.
Basic periodontal examination (BPE, including visual examination and mechanical probing of gum) will be performed for all of them and assign to the undergraduate students for patient care according to the severity.
Computer record can retrieve patients with gum inflammation (BPE score 2). Data handling All data will be kept reviewed by unblended member (YHL) to check the quality. Only the data that related to the study outcomes will be disclosed. All the data will be kept for another two years since the study finishes. After that, the data will be destroyed completely. Primary investigator will have access to the personal data during and after the study.
- Conditions
- Gingivitis
- Being tested
- Oral hygiene instruction and simple scaling
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral hygiene instruction and simple scalingProcedure or surgery
Monitor the changes of gum condition
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical gingival inflammation at 3 month
Mean number/Percentage of sites with, as determined by the plaque index (Silness and Loe 1965 from 0 to 3) by observation of patient's mouth
Measured: 3-month
Photographic gingival inflammation at 3 month
Mean number/Percentage of sites with, as determined by the plaque index (Silness and Loe 1965 from 0 to 3) by observation of patient's standardized photo
Measured: 3-month
Photographic gingival inflammation at baseline
Mean number/Percentage of sites with, as determined by the plaque index (Silness and Loe 1965 from 0 to 3) by observation of patient's standardized photo
Measured: baseline
Clinical gingival inflammation at baseline
Mean number/Percentage of sites with, as determined by the plaque index (Silness and Loe 1965 from 0 to 3) by observation of patient's mouth
Measured: baseline
Secondary outcomes (1)
Patient reported outcome on the use of smartphone selfie
Satisfactory in Visual analogue scale (VAS) from 0 (not satisfactory) to 100 (satisfactory)
Measured: 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start1 Jan 2023
- Primary completion31 Dec 2024
- Study completion24 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Walter Y.H. Lam, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326413
- Sponsor's protocol ID
- HKWC-2019-0666
- Status last verified
- Mar 2025
- First submitted
- 25 Mar 2020
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence Evaluation of Periodontal Health Using Selfie Intraoral Photography
- ClinicalTrials.gov ID
- NCT04326413
- Acronym / sponsor ID
- HKWC-2019-0666
- Conditions
- Gingivitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 24 Mar 2025 (actual)
- First posted
- 30 Mar 2020 (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.
Periodontal (gum) disease affecting more than 90% of the population globally. The soft and hard tissues that supporting the teeth are being affected. If untreated, the disease progresses from the mild and reversible form (i.e. gingivitis) that involves superficial gum only to the more severe and irreversible form (i.e. periodontitis) that involves loss of periodontal ligament and bone. Teeth will be lost eventually and significantly impairs the function and the oral health related quality of health. Moreover, periodontal disease has been strongly linked to the systemic diseases via centrally or local routes with significant health implications.
Periodontal disease is initiated by bacteria (plaque) adhere on tooth surfaces and the body defense by eliciting inflammatory response. The disease and associated inflammation is site-specific and the affected gum is manifested with the cardinal signs of inflammation such as redness (color), swelling (increased volume), edema (loss of surface characteristics) and bleeds easily. Dentists are trained to identify the disease sites by visual (redness and swelling) and by mechanical probing (bleeding). Traditionally these give rises to clinical gum indices showing the degree of inflammation and are important to the clinical monitoring and management of gum diseases.
The management of periodontal disease involves the removal of bacteria plaque by both dentists' tooth cleaning and maintained by patients' daily home-care. Home-care plaque removal has been shown by many studies to prevent and/or cease the development of periodontitis. However, most patients do not able to remove plaque effectively and it only takes few days for a health site to development inflammation. Professional monitoring and feedback are highly desirable but many patients only have monthly or even yearly appointment which is too late. Such "non-compliance" increase the treatment cost/time, patient discomfort and reduce treatment efficacy. Moreover, many patients do not receive regular dental checkup and they seek dentists when the gum problem becomes irreversible that complicated and expensive treatment such as tooth extraction and rehabilitation is required.
This study consists of 1) collecting the standardized clinical photography with clinical gum indices/ marked by an experienced clinician, 2) import into computer for training, and 3) longitudinally monitoring and analyze of gum condition in a group of gingivitis patients receiving gum treatment.
Detailed description
The first part of this study will collect buccal view of intraoral photo and clinical gum indices from 300 patients visiting Prince Philip Dental Hospital (PPDH). These intraoral photo will be taken by patients using smartphone (iphone) mounted with apparatus (Scanbox) in a standardized way and the quality supervised by clinical staff. Clinical gum indices will be taken by a trained and calibrated clinical staff. Alternatively clinical photo may be assessed by an experienced clinician to locate the inflamed/health gum. This synthesized data set imported into neural network to learn the image characteristics of inflamed and health gum and train the computer.
The second part of this study will recruit 150 patients with gingivitis and longitudinally follow up their gum condition pre- and post- gum treatment in PPDH using standardized intraoral photo and clinical gum indices. The clinical gum indices are the gold standard reflecting the changes in the gum condition.
All photos collected would be analyzed by computer (software: MatLab) to identify key features that help with screening and monitoring of gum condition. Data would then be collected for building a program that quantifies the identified features which may include the following:
- Color of marginal gum tissues
- Texture of marginal gum tissues
- Volume of marginal gum tissues, with reference to the clinical gum indices.
Data and sample size analysis: The computer will be trained with the photo and clinical indices/assessment obtained in the part I of this study. The trained computer will then use to monitor changes of periodontal condition of patients in part II of this study based on photo only. The sensitivity (detect true disease), specificity (detect true health) and the area under these curves (with reference to the gold standard clinical gum indices) will be calculated and are the main outcome of this study. The training of computer is a continuous process and the endpoint comes when the sensitivity, specificity and the area under these curves (AUC) reach plateau (saturation). Therefore, the training of computer will be staged into three phrases with 100, 200 and 300 of cases in the part I of this study and observe the changes in the sensitivity, specificity and AUC.
Patient reported outcome on the use of smartphone selfie would be recorded in visual analogue scale (VAS) as secondary outcome.
Sample size determination: Each tooth represents one unit and assume each subject has 20 teeth, there will be more than 300 subjects X 20 teeth =6000 units for training. For the part 2 study, 150 subjects will be recruited and 130X20=2600 units for testing of the computer.
All new patients attending Prince Philip Dental Hospital will be screen for gum inflammation and periodontal diseases by clinical examination.
Basic periodontal examination (BPE, including visual examination and mechanical probing of gum) will be performed for all of them and assign to the undergraduate students for patient care according to the severity.
Computer record can retrieve patients with gum inflammation (BPE score 2). Data handling All data will be kept reviewed by unblended member (YHL) to check the quality. Only the data that related to the study outcomes will be disclosed. All the data will be kept for another two years since the study finishes. After that, the data will be destroyed completely. Primary investigator will have access to the personal data during and after the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy dentate patients with gingivitis only and have 24 or more teeth
Key inclusion criteria (4 listed)
- Adult subjects attending PPDH and are able to give informed consent
- Subjects who diagnosed to have gingivitis only and have 24 or more teeth
- Subjects who are otherwise medically health
- Subjects who are able to attend multiple dental visits
Key exclusion criteria (4 listed)
- Subjects who are in acute dental infection or in pain
- Subjects who have oral mucosal diseases that preclude retraction of soft tissues for photos
- Subjects who are in fixed appliance for orthodontic treatment
- Subjects who are pregnancy, or medically unfit for periodontal charting or requires antibiotic coverage (e.g. risk of infective endocarditis)
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 |
|---|---|---|
| Oral hygiene instruction and simple scalingMonitor the changes of gum condition | Procedure or surgery | – |
Primary outcome
Clinical gingival inflammation at 3 month
Time frame: 3-month
Mean number/Percentage of sites with, as determined by the plaque index (Silness and Loe 1965 from 0 to 3) by observation of patient's mouth
Photographic gingival inflammation at 3 month
Time frame: 3-month
Mean number/Percentage of sites with, as determined by the plaque index (Silness and Loe 1965 from 0 to 3) by observation of patient's standardized photo
Photographic gingival inflammation at baseline
Time frame: baseline
Mean number/Percentage of sites with, as determined by the plaque index (Silness and Loe 1965 from 0 to 3) by observation of patient's standardized photo
Clinical gingival inflammation at baseline
Time frame: baseline
Mean number/Percentage of sites with, as determined by the plaque index (Silness and Loe 1965 from 0 to 3) by observation of patient's mouth
1 secondary outcome
Patient reported outcome on the use of smartphone selfie
Time frame: 3-month
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 28 Mar 2025.
- 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.
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 Gingivitis, run by The University of Hong Kong at 1 site in Hong Kong.
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 4 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: finished, as of the sponsor's last update on 28 Mar 2025. 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 Hong Kong. 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?
Clinical gingival inflammation at 3 month (time frame: 3-month). The study lists 4 primary outcomes in all. 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 28 Mar 2025.