Periodontal DiseasesNCT06083649
The Dental Care Revolution: Health Education Using AI or Humanized Counseling on Plague Control and Periodontal Treatment Outcome in Patients With Periodontal Disease
A study testing The AI-assisted tool used in this study was called Dental Monitoring (DM). in people with Periodontal Diseases, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
The aim of this study was to evaluate the long-term effectiveness of an AI dental monitoring intervention on patients' periodontal disease, preventive behaviors and motivation. This randomized controlled trial included experimental group: AI group (EG-A), AI-humanized group (EG-B) and control group(CG), respectively. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- The AI-assisted tool used in this study was called Dental Monitoring (DM).
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Aug 2020to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 35-65 years old
- Diagnosed periodontal disease by dentist (Comprehensive Periodontal Treatment Project)
- More than 16 functional teeth
Who cannot join
- Have received periodontal treatment within 3 months
- Patient has disease related to periodontal disease (ex. Drug-related excessive gum growth or blood clotting problems, pregnancy, mental illness)
- Disability patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
FU-TZU YOU, +886-7-3121101 ext. 2159, alicedh110@gmail.com
About this study
The aim of this study was to evaluate the long-term effectiveness of an AI dental monitoring intervention on patients' periodontal disease, preventive behaviors and motivation. This randomized controlled trial included experimental group: AI group (EG-A), AI-humanized group (EG-B) and control group(CG), respectively.
The EG-A and EG-B received AI dental monitoring intervention by taking mouth image at home once a week for six month. Baseline and follow-up surveys were used to collect the data in oral health related quality of life,periodontal parameters, periodontal preventive behaviors and motivation.
Read the detailed description
A randomized experimental design was used. Patients with periodontal disease whose aged 35-65 years were recruited through department of Periodontics in Kaohsiung Medical University Hospital.
Each group was expected for 100 per group, patients will be randomized into each group. G*Power (version 3.1.9.4) was used for power analysis.
All patients will underwent periodontal examination at baseline and at 1-month, 3-month, 6-month follow-ups.
Each patients will be diagnosed periodontal disease by dentist and have more than 16 functional teeth.
Each patients will completed the questionnaire at baseline and at 1-month, 3-month and 6-month follow-up.
- Conditions
- Periodontal Diseases
- Being tested
- The AI-assisted tool used in this study was called Dental Monitoring (DM).
- Keywords
- periodontal disease, artificial intelligence (AI), OHRQoL
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The AI-assisted tool used in this study was called Dental Monitoring (DM).Behavioural
DM is the first APP system used in orthopedics patients in the world,it has been widely used in Asian countries (Taiwan, Hong Kong, Singapore, Japan,etc.) and has been used by 2140 patients so far. DM allows patients to take in-mouth photos at home, and uses AI as a background analysis to evaluate the patient's current oral condition (including oral hygiene and gum status) based on the photo.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group A (AI Group: EG-A) | Experimental | The AI group scanned their own mouths at home once a week for 6 months, with each scan taking approximately 5 min. After scanning, they uploaded the results to the AI system for evaluation. The AI system then selected and sent a message to each patient depending on their intraoral conditions. Receives: Behavioral: The AI-assisted tool used in this study was called Dental Monitoring (DM). |
| Experimental group B (AI and health counseling group: EG-B) | Experimental | The AI and health counseling group scanned their own mouths at home once a week for 6 months, with each scan taking approximately 5 min. After scanning, they uploaded the results to the AI system for evaluation. The EG-B received both AI-assisted DM and real-person oral health counseling and advice from a counselor, who assessed their oral hygiene conditions on the basis of their scanning results and then provided individualized counseling, such as pointing out unclean teeth and offering suggestions on cleaning tools. Receives: Behavioral: The AI-assisted tool used in this study was called Dental Monitoring (DM). |
| No Intervention: Control group (CG) | No intervention | the control group(CG) only have standard oral hygiene education |
What is being measured
The primary outcome is the main question the study is designed to answer.
gingival index (GI)
The gingival inflammation status of 6 tooth was recorded using the gingiva index, as follows:
0 = No inflammation.
- = Mild inflammation, slight change in color, slight edema, no bleeding on probing
- = Moderate inflammation, moderate glazing, redness, bleeding on probing
- = Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.
For each patient, GI will measured by the teeth 12,16,24,32,36,44
Measured: Change from Baseline GI at 1-month after intervention
gingival index (GI)
The gingival inflammation status of 6 tooth was recorded using the gingiva index, as follows:
0 = No inflammation.
- = Mild inflammation, slight change in color, slight edema, no bleeding on probing
- = Moderate inflammation, moderate glazing, redness, bleeding on probing
- = Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.
For each patient, GI will measured by the teeth 12,16,24,32,36,44
Measured: Change from Baseline GI at 3-month after intervention
gingival index (GI)
The gingival inflammation status of 6 tooth was recorded using the gingiva index, as follows:
0 = No inflammation.
- = Mild inflammation, slight change in color, slight edema, no bleeding on probing
- = Moderate inflammation, moderate glazing, redness, bleeding on probing
- = Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.
For each patient, GI will measured by the teeth 12,16,24,32,36,44
Measured: Change from Baseline GI at 6-month after intervention
plaque index (PI)
The plaque status of 6 tooth was recorded using the plaque index, as followes:
0 = No plaque
- = Thin film of plaque, scraped with explorer
- = Moderate amount of plaque, visible with naked eyes
- = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
For each patient, PI will measured by the teeth 12,16,24,32,36,44
Measured: Change from Baseline PI at 1-month after intervention
plaque index (PI)
The plaque status of 6 tooth was recorded using the plaque index, as followes:
0 = No plaque
- = Thin film of plaque, scraped with explorer
- = Moderate amount of plaque, visible with naked eyes
- = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
For each patient, PI will measured by the teeth 12,16,24,32,36,44
Measured: Change from Baseline PI at 3-month after intervention
plaque index (PI)
The plaque status of 6 tooth was recorded using the plaque index, as followes:
0 = No plaque
- = Thin film of plaque, scraped with explorer
- = Moderate amount of plaque, visible with naked eyes
- = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
For each patient, PI will measured by the teeth 12,16,24,32,36,44
Measured: Change from Baseline PI at 6-month after intervention
Probing Pocket Depth (PPD)
Using periodontal probe to measure the depth from the bottom of the periodontal pocket to the gingival margin, recorded at six sites (mesial [buccal and lingual/palatal], distal [buccal and lingual/palatal], mid-buccal, and mid-lingual/palatal) around each tooth, except for the third molar.
Measured: Change from Baseline PPD at 1-month after intervention
Probing Pocket Depth (PPD)
Using periodontal probe to measure the depth from the bottom of the periodontal pocket to the gingival margin, recorded at six sites (mesial [buccal and lingual/palatal], distal [buccal and lingual/palatal], mid-buccal, and mid-lingual/palatal) around each tooth, except for the third molar.
Measured: Change from Baseline PPD at 3-month after intervention
Probing Pocket Depth (PPD)
Using periodontal probe to measure the depth from the bottom of the periodontal pocket to the gingival margin, recorded at six sites (mesial [buccal and lingual/palatal], distal [buccal and lingual/palatal], mid-buccal, and mid-lingual/palatal) around each tooth, except for the third molar.
Measured: Change from Baseline PPD at 6-month after intervention
Clinical Attachment Loss(CAL)
Using periodontal probe to measure the distance from the enamel-dentin junction to the bottom of the periodontal pocket.
- Page 4 of 8 - For each patient, CAL will measured each teeth.
Measured: Change from Baseline CAL at 1-month after intervention
Clinical Attachment Loss(CAL)
Using periodontal probe to measure the distance from the enamel-dentin junction to the bottom of the periodontal pocket.
- Page 4 of 8 - For each patient, CAL will measured each teeth.
Measured: Change from Baseline CAL at 3-month after intervention
Clinical Attachment Loss(CAL)
Using periodontal probe to measure the distance from the enamel-dentin junction to the bottom of the periodontal pocket.
- Page 4 of 8 - For each patient, CAL will measured each teeth.
Measured: Change from Baseline CAL at 6-month after intervention
OHRQoL(OHIP-14T scales)
Item including that because of problems with your teeth or mouth, you:
- Have you had trouble pronouncing any words because of problems"
- Have you felt that your sense of taste has worsened"
- Have you had painful aching in your mouth"
- Have you found it uncomfortable to eat any foods"
- Have you been self-conscious"
- Have you felt tense"
- Has been your diet been unsatisfactory"
- Have you had to interrupt meals?"
- Have you found it difficult to relax"
- Have you been a bit embarrassed"
- Have you been a bit irritable with other people"
- Have you had difficulty doing your usual jobs"
- Have you felt that life in general was less satisfying"
- Have you been totally unable to function" Responses are scored on a 5-point Likert scale with endpoints ranging from 0 (never) to 4 (very often), indicating the frequency of the problem over the preceding 6 months. The possible scores were 0-56, with lower scores indicating more favorable OHRQoL.
Measured: Change from Baseline at 1 month after intervention
OHRQoL(OHIP-14T scales)
Item including that because of problems with your teeth or mouth, you:
- Have you had trouble pronouncing any words because of problems"
- Have you felt that your sense of taste has worsened"
- Have you had painful aching in your mouth"
- Have you found it uncomfortable to eat any foods"
- Have you been self-conscious"
- Have you felt tense"
- Has been your diet been unsatisfactory"
- Have you had to interrupt meals?"
- Have you found it difficult to relax"
- Have you been a bit embarrassed"
- Have you been a bit irritable with other people"
- Have you had difficulty doing your usual jobs"
- Have you felt that life in general was less satisfying"
- Have you been totally unable to function" Responses are scored on a 5-point Likert scale with endpoints ranging from 0 (never) to 4 (very often), indicating the frequency of the problem over the preceding 6 months. The possible scores were 0-56, with lower scores indicating more favorable OHRQoL.
Measured: Change from Baseline at 3 month after intervention
OHRQoL(OHIP-14T scales)
Item including that because of problems with your teeth or mouth, you:
- Have you had trouble pronouncing any words because of problems"
- Have you felt that your sense of taste has worsened"
- Have you had painful aching in your mouth"
- Have you found it uncomfortable to eat any foods"
- Have you been self-conscious"
- Have you felt tense"
- Has been your diet been unsatisfactory"
- Have you had to interrupt meals?"
- Have you found it difficult to relax"
- Have you been a bit embarrassed"
- Have you been a bit irritable with other people"
- Have you had difficulty doing your usual jobs"
- Have you felt that life in general was less satisfying"
- Have you been totally unable to function" Responses are scored on a 5-point Likert scale with endpoints ranging from 0 (never) to 4 (very often), indicating the frequency of the problem over the preceding 6 months. The possible scores were 0-56, with lower scores indicating more favorable OHRQoL.
Measured: Change from Baseline at 6 month after intervention
Secondary outcomes (6)
Protection Motivation Theory (PMT) scores
Item including that "I think periodontal disease is a serious disease"
- If I do not have periodontal disease prevention behavior, the risk of developing periodontal disease in the future is very high"
- If I stick to periodontal disease prevention behavior, it will improve my oral health"
- I believe that I can follow the periodontal health guidance"
- I find it hard to remember/hard to do periodontal health care guidance"
- Periodontal disease bothers me"
- I want to complete my personal periodontal disease prevention behavior plan" All the items' scores ranged from one to ten, with higher scores indicating a higher level of motivation toward change behaviors.
Cronbach's α was 0.70 for this scale. The scores ranged from one ("impossible") to ten ("very possible"), with the total possible score ranging from seven to seventy
Measured: Change from Baseline PMT at 1-month after intervention
Protection Motivation Theory (PMT) scores
Item including that "I think periodontal disease is a serious disease"
- If I do not have periodontal disease prevention behavior, the risk of developing periodontal disease in the future is very high"
- If I stick to periodontal disease prevention behavior, it will improve my oral health"
- I believe that I can follow the periodontal health guidance"
- I find it hard to remember/hard to do periodontal health care guidance"
- Periodontal disease bothers me"
- I want to complete my personal periodontal disease prevention behavior plan" All the items' scores ranged from one to ten, with higher scores indicating a higher level of motivation toward change behaviors.
Cronbach's α was 0.70 for this scale. The scores ranged from one ("impossible") to ten ("very possible"), with the total possible score ranging from seven to seventy
Measured: Change from Baseline PMT at 3-month after intervention
Protection Motivation Theory (PMT) scores
Item including that "I think periodontal disease is a serious disease"
- If I do not have periodontal disease prevention behavior, the risk of developing periodontal disease in the future is very high"
- If I stick to periodontal disease prevention behavior, it will improve my oral health"
- I believe that I can follow the periodontal health guidance"
- I find it hard to remember/hard to do periodontal health care guidance"
- Periodontal disease bothers me"
- I want to complete my personal periodontal disease prevention behavior plan" All the items' scores ranged from one to ten, with higher scores indicating a higher level of motivation toward change behaviors.
Cronbach's α was 0.70 for this scale. The scores ranged from one ("impossible") to ten ("very possible"), with the total possible score ranging from seven to seventy
Measured: Change from Baseline PMT at 6-month after intervention
oral self-care behavior
Item including that:
"How many times do you brush your teeth a day?" The response was (once or twice day or three times or fours times or more/ day).
"How long do you usually brush your teeth each time?" The response was lower than 1 min or 1-2 min or 2-3 min or more than 3 min/ day.
"What is your main method of brushing your teeth?"The response was horizontally or vertically or Circle brush or Rotating brush or Horizontal+vertical+ and by the gum at a 45 degree angle.
"How often do you replace your toothbrush?" The response was 3-6 month or more than 6 month or lower than 1 month or 1-2 month or 2-3 month.
"Do you use a soft-bristled toothbrush?" The response was no or unknown or yes. "Do you have a habit of using interdental brushes?" The response was no or yes. "Do you have a habit of eating snack?" The response was no or yes.
Measured: Change from Baseline at 1 month after intervention
oral self-care behavior
Item including that:
"How many times do you brush your teeth a day?" The response was (once or twice day or three times or fours times or more/ day).
"How long do you usually brush your teeth each time?" The response was lower than 1 min or 1-2 min or 2-3 min or more than 3 min/ day.
"What is your main method of brushing your teeth?"The response was horizontally or vertically or Circle brush or Rotating brush or Horizontal+vertical+ and by the gum at a 45 degree angle.
"How often do you replace your toothbrush?" The response was 3-6 month or more than 6 month or lower than 1 month or 1-2 month or 2-3 month.
"Do you use a soft-bristled toothbrush?" The response was no or unknown or yes. "Do you have a habit of using interdental brushes?" The response was no or yes. "Do you have a habit of eating snack?" The response was no or yes.
Measured: Change from Baseline at 3 month after intervention
oral self-care behavior
Item including that:
"How many times do you brush your teeth a day?" The response was (once or twice day or three times or fours times or more/ day).
"How long do you usually brush your teeth each time?" The response was lower than 1 min or 1-2 min or 2-3 min or more than 3 min/ day.
"What is your main method of brushing your teeth?"The response was horizontally or vertically or Circle brush or Rotating brush or Horizontal+vertical+ and by the gum at a 45 degree angle.
"How often do you replace your toothbrush?" The response was 3-6 month or more than 6 month or lower than 1 month or 1-2 month or 2-3 month.
"Do you use a soft-bristled toothbrush?" The response was no or unknown or yes. "Do you have a habit of using interdental brushes?" The response was no or yes. "Do you have a habit of eating snack?" The response was no or yes.
Measured: Change from Baseline at 6 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start10 Aug 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsiao-Ling Huang, Dr.PH, Principal investigator, Kaohsiung Medical University, College of Dental Medicine, Department of Oral Hygiene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083649
- Sponsor's protocol ID
- KMUHIRB-F(II)-20200059
- Status last verified
- Feb 2025
- First submitted
- 9 Oct 2023
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dental Care Revolution: Health Education Using AI or Humanized Counseling on Plague Control and Periodontal Treatment Outcome in Patients With Periodontal Disease
- ClinicalTrials.gov ID
- NCT06083649
- Acronym / sponsor ID
- KMUHIRB-F(II)-20200059
- Conditions
- Periodontal Diseases
- Keywords
- periodontal disease, artificial intelligence (AI), OHRQoL
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Oct 2023 (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 aim of this study was to evaluate the long-term effectiveness of an AI dental monitoring intervention on patients' periodontal disease, preventive behaviors and motivation. This randomized controlled trial included experimental group: AI group (EG-A), AI-humanized group (EG-B) and control group(CG), respectively.
The EG-A and EG-B received AI dental monitoring intervention by taking mouth image at home once a week for six month. Baseline and follow-up surveys were used to collect the data in oral health related quality of life,periodontal parameters, periodontal preventive behaviors and motivation.
Detailed description
A randomized experimental design was used. Patients with periodontal disease whose aged 35-65 years were recruited through department of Periodontics in Kaohsiung Medical University Hospital.
Each group was expected for 100 per group, patients will be randomized into each group. G*Power (version 3.1.9.4) was used for power analysis.
All patients will underwent periodontal examination at baseline and at 1-month, 3-month, 6-month follow-ups.
Each patients will be diagnosed periodontal disease by dentist and have more than 16 functional teeth.
Each patients will completed the questionnaire at baseline and at 1-month, 3-month and 6-month follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group A (AI Group: EG-A) | Experimental | Behavioral: The AI-assisted tool used in this study was called Dental Monitoring (DM).The AI group scanned their own mouths at home once a week for 6 months, with each scan taking approximately 5 min. After scanning, they uploaded the results to the AI system for evaluation. The AI system then selected and sent a message to each patient depending on their intraoral conditions. |
| Experimental group B (AI and health counseling group: EG-B) | Experimental | Behavioral: The AI-assisted tool used in this study was called Dental Monitoring (DM).The AI and health counseling group scanned their own mouths at home once a week for 6 months, with each scan taking approximately 5 min. After scanning, they uploaded the results to the AI system for evaluation. The EG-B received both AI-assisted DM and real-person oral health counseling and advice from a counselor, who assessed their oral hygiene conditions on the basis of their scanning results and then provided individualized counseling, such as pointing out unclean teeth and offering suggestions on cleaning tools. |
| No Intervention: Control group (CG) | No intervention | –the control group(CG) only have standard oral hygiene education |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 35-65 years old
- Diagnosed periodontal disease by dentist (Comprehensive Periodontal Treatment Project)
- More than 16 functional teeth
Key exclusion criteria (3 listed)
- Have received periodontal treatment within 3 months
- Patient has disease related to periodontal disease (ex. Drug-related excessive gum growth or blood clotting problems, pregnancy, mental illness)
- Disability patients
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 |
|---|---|---|
| The AI-assisted tool used in this study was called Dental Monitoring (DM).DM is the first APP system used in orthopedics patients in the world,it has been widely used in Asian countries (Taiwan, Hong Kong, Singapore, Japan,etc.) and has been used by 2140 patients so far. DM allows patients to take in-mouth photos at home, and uses AI as a background analysis to evaluate the patient's current oral condition (including oral hygiene and gum status) based on the photo. | Behavioural | Experimental group A (AI Group: EG-A), Experimental group B (AI and health counseling group: EG-B) |
Primary outcome
gingival index (GI)
Time frame: Change from Baseline GI at 1-month after intervention
The gingival inflammation status of 6 tooth was recorded using the gingiva index, as follows: 0 = No inflammation. 1. = Mild inflammation, slight change in color, slight edema, no bleeding on probing 2. = Moderate inflammation, moderate glazing, redness, bleeding on probing 3. = Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding. For each patient, GI will measured by the teeth 12,16,24,32,36,44
gingival index (GI)
Time frame: Change from Baseline GI at 3-month after intervention
The gingival inflammation status of 6 tooth was recorded using the gingiva index, as follows: 0 = No inflammation. 1. = Mild inflammation, slight change in color, slight edema, no bleeding on probing 2. = Moderate inflammation, moderate glazing, redness, bleeding on probing 3. = Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding. For each patient, GI will measured by the teeth 12,16,24,32,36,44
gingival index (GI)
Time frame: Change from Baseline GI at 6-month after intervention
The gingival inflammation status of 6 tooth was recorded using the gingiva index, as follows: 0 = No inflammation. 1. = Mild inflammation, slight change in color, slight edema, no bleeding on probing 2. = Moderate inflammation, moderate glazing, redness, bleeding on probing 3. = Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding. For each patient, GI will measured by the teeth 12,16,24,32,36,44
plaque index (PI)
Time frame: Change from Baseline PI at 1-month after intervention
The plaque status of 6 tooth was recorded using the plaque index, as followes: 0 = No plaque 1. = Thin film of plaque, scraped with explorer 2. = Moderate amount of plaque, visible with naked eyes 3. = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. For each patient, PI will measured by the teeth 12,16,24,32,36,44
plaque index (PI)
Time frame: Change from Baseline PI at 3-month after intervention
The plaque status of 6 tooth was recorded using the plaque index, as followes: 0 = No plaque 1. = Thin film of plaque, scraped with explorer 2. = Moderate amount of plaque, visible with naked eyes 3. = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. For each patient, PI will measured by the teeth 12,16,24,32,36,44
plaque index (PI)
Time frame: Change from Baseline PI at 6-month after intervention
The plaque status of 6 tooth was recorded using the plaque index, as followes: 0 = No plaque 1. = Thin film of plaque, scraped with explorer 2. = Moderate amount of plaque, visible with naked eyes 3. = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. For each patient, PI will measured by the teeth 12,16,24,32,36,44
Probing Pocket Depth (PPD)
Time frame: Change from Baseline PPD at 1-month after intervention
Using periodontal probe to measure the depth from the bottom of the periodontal pocket to the gingival margin, recorded at six sites (mesial [buccal and lingual/palatal], distal [buccal and lingual/palatal], mid-buccal, and mid-lingual/palatal) around each tooth, except for the third molar.
Probing Pocket Depth (PPD)
Time frame: Change from Baseline PPD at 3-month after intervention
Using periodontal probe to measure the depth from the bottom of the periodontal pocket to the gingival margin, recorded at six sites (mesial [buccal and lingual/palatal], distal [buccal and lingual/palatal], mid-buccal, and mid-lingual/palatal) around each tooth, except for the third molar.
Probing Pocket Depth (PPD)
Time frame: Change from Baseline PPD at 6-month after intervention
Using periodontal probe to measure the depth from the bottom of the periodontal pocket to the gingival margin, recorded at six sites (mesial [buccal and lingual/palatal], distal [buccal and lingual/palatal], mid-buccal, and mid-lingual/palatal) around each tooth, except for the third molar.
Clinical Attachment Loss(CAL)
Time frame: Change from Baseline CAL at 1-month after intervention
Using periodontal probe to measure the distance from the enamel-dentin junction to the bottom of the periodontal pocket. - Page 4 of 8 - For each patient, CAL will measured each teeth.
Clinical Attachment Loss(CAL)
Time frame: Change from Baseline CAL at 3-month after intervention
Using periodontal probe to measure the distance from the enamel-dentin junction to the bottom of the periodontal pocket. - Page 4 of 8 - For each patient, CAL will measured each teeth.
Clinical Attachment Loss(CAL)
Time frame: Change from Baseline CAL at 6-month after intervention
Using periodontal probe to measure the distance from the enamel-dentin junction to the bottom of the periodontal pocket. - Page 4 of 8 - For each patient, CAL will measured each teeth.
OHRQoL(OHIP-14T scales)
Time frame: Change from Baseline at 1 month after intervention
Item including that because of problems with your teeth or mouth, you: * Have you had trouble pronouncing any words because of problems" * Have you felt that your sense of taste has worsened" * Have you had painful aching in your mouth" * Have you found it uncomfortable to eat any foods" * Have you been self-conscious" * Have you felt tense" * Has been your diet been unsatisfactory" * Have you had to interrupt meals?" * Have you found it difficult to relax" * Have you been a bit embarrassed" * Have you been a bit irritable with other people" * Have you had difficulty doing your usual jobs" * Have you felt that life in general was less satisfying" * Have you been totally unable to function" Responses are scored on a 5-point Likert scale with endpoints ranging from 0 (never) to 4 (very often), indicating the frequency of the problem over the preceding 6 months. The possible scores were 0-56, with lower scores indicating more favorable OHRQoL.
OHRQoL(OHIP-14T scales)
Time frame: Change from Baseline at 3 month after intervention
Item including that because of problems with your teeth or mouth, you: * Have you had trouble pronouncing any words because of problems" * Have you felt that your sense of taste has worsened" * Have you had painful aching in your mouth" * Have you found it uncomfortable to eat any foods" * Have you been self-conscious" * Have you felt tense" * Has been your diet been unsatisfactory" * Have you had to interrupt meals?" * Have you found it difficult to relax" * Have you been a bit embarrassed" * Have you been a bit irritable with other people" * Have you had difficulty doing your usual jobs" * Have you felt that life in general was less satisfying" * Have you been totally unable to function" Responses are scored on a 5-point Likert scale with endpoints ranging from 0 (never) to 4 (very often), indicating the frequency of the problem over the preceding 6 months. The possible scores were 0-56, with lower scores indicating more favorable OHRQoL.
OHRQoL(OHIP-14T scales)
Time frame: Change from Baseline at 6 month after intervention
Item including that because of problems with your teeth or mouth, you: * Have you had trouble pronouncing any words because of problems" * Have you felt that your sense of taste has worsened" * Have you had painful aching in your mouth" * Have you found it uncomfortable to eat any foods" * Have you been self-conscious" * Have you felt tense" * Has been your diet been unsatisfactory" * Have you had to interrupt meals?" * Have you found it difficult to relax" * Have you been a bit embarrassed" * Have you been a bit irritable with other people" * Have you had difficulty doing your usual jobs" * Have you felt that life in general was less satisfying" * Have you been totally unable to function" Responses are scored on a 5-point Likert scale with endpoints ranging from 0 (never) to 4 (very often), indicating the frequency of the problem over the preceding 6 months. The possible scores were 0-56, with lower scores indicating more favorable OHRQoL.
6 secondary outcomes
Protection Motivation Theory (PMT) scores
Time frame: Change from Baseline PMT at 1-month after intervention
Protection Motivation Theory (PMT) scores
Time frame: Change from Baseline PMT at 3-month after intervention
Protection Motivation Theory (PMT) scores
Time frame: Change from Baseline PMT at 6-month after intervention
oral self-care behavior
Time frame: Change from Baseline at 1 month after intervention
oral self-care behavior
Time frame: Change from Baseline at 3 month after intervention
oral self-care behavior
Time frame: Change from Baseline at 6 month after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
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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.
Hsiao-Ling Huang, Dr.PH principal investigator
Kaohsiung Medical University, College of Dental Medicine, Department of Oral Hygiene
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The AI-assisted tool used in this study was called Dental Monitoring (DM). in people with Periodontal Diseases, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 3 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: looking for participants now, as of the sponsor's last update on 6 Feb 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hsiao-Ling Huang (+886-7-312-1101#2159, hhuang@kmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gingival index (GI) (time frame: Change from Baseline GI at 1-month after intervention). The study lists 15 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 6 Feb 2025.