Peri-Implant MucositisNCT07300657
Impact of an AI-Based Chatbot on Implant Patient Management: RCT
A study testing AI Chatbot and Standard Oral Hygiene Education in people with Peri-Implant Mucositis and Peri-implantitis, run by University of Catania at 1 site in Italy.
Trial summary
Background: Dental implant therapy is a well-established and predictable procedure for replacing missing teeth, with high long-term survival rates. However, poor oral hygiene remains one of the main modifiable risk factors for peri-implant diseases such as mucositis and peri-implantitis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-Implant Mucositis, Peri-implantitis, Peri-Implant Health
- What is being tested?
- AI Chatbot and Standard Oral Hygiene Education
- 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
- 110 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2024to 30 Jun 2025
- Phase
- Interventional
- 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
Who may be able to join
- Systemically healthy or with controlled systemic conditions;
- Good periodontal health on either an intact or reduced periodontium;
- Regular adherence to supportive periodontal therapy (SPT);
- Presence of at least one osseointegrated dental implant in the maxilla or mandible, following transmucosal healing for 2-4 months;
- Daily access to a smartphone.
Who cannot join
- Age < 18 years;
- Untreated or active periodontal disease;
- Currently undergoing orthodontic therapy;
- Patients with cognitive deficits;
- Smoking habit (more than 10 cigarettes per day);
- History of heavy alcohol consumption;
- Use of immunosuppressive medication;
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Intradepartmental Program of Oral Surgery and Early Detection of Oral Cancer, G. Rodolico - San Marco Hospital, AOU Policlinico - San Marco
Catania, 95124
About this study
Official title: Impact of an Artificial Intelligence-Based Chatbot on Implant Patient Management: A Randomised Controlled Trial
Background: Dental implant therapy is a well-established and predictable procedure for replacing missing teeth, with high long-term survival rates. However, poor oral hygiene remains one of the main modifiable risk factors for peri-implant diseases such as mucositis and peri-implantitis.
Objective: The aim of this randomized controlled clinical trial is to evaluate the effectiveness of an artificial intelligence (AI)-based chatbot, developed and validated by dental experts, in improving oral hygiene and clinical outcomes in patients with implant-supported restorations, compared to traditional educational methods such as printed leaflets and dental hygienist sessions.
Read more
Methods: A total of 110 adult patients rehabilitated with dental implants were randomly assigned to either an AI chatbot intervention group or a control group receiving standard oral hygiene education. The chatbot provides continuous, personalized education and motivation through natural language interaction. Clinical and radiographic parameters, including plaque index (PI), bleeding on probing (BOP), probing pocket depth (PPD), and marginal bone loss (MBL), were recorded at baseline and at follow-up visits.
Expected outcomes: It is hypothesized that the use of an AI-based chatbot will significantly improve oral hygiene compliance and clinical outcomes compared to conventional methods.
Significance: The study aims to demonstrate the potential of AI-assisted patient education in promoting long-term peri-implant health and preventing peri-implant diseases.
Read the detailed description
Rationale and Background:
Dental implant therapy is highly successful, but peri-implant diseases, primarily caused by inadequate plaque control, remain a major cause of implant failure. Conventional oral hygiene education methods, such as verbal instructions and printed materials, often fail to ensure long-term patient compliance. Artificial intelligence (AI)-based chatbots, powered by large language models, offer a new way to provide continuous, personalized education and motivation to patients. Although their potential has been explored in orthodontics, little is known about their role in peri-implant maintenance.
Study Objective:
This randomized controlled clinical trial investigates whether an AI-based chatbot developed by dental experts can improve oral hygiene compliance and peri-implant health compared to traditional educational methods.
Study Design:
A total of 110 participants were enrolled between June 2024 and June 2025 in private dental practices in Catania, Italy. The study was approved by the local ethics committee (Protocol ID: 60/2024/CL-PAR) and conducted in accordance with the Declaration of Helsinki (2016 revision). Eligible participants were adults (≥18 years), systemically healthy or with controlled conditions, attending regular supportive periodontal therapy, and having at least one osseointegrated implant. Exclusion criteria included active periodontal disease, heavy smoking, systemic immunosuppression, and pregnancy.
Interventions:
Participants were randomly assigned to two groups:
Chatbot group: Received oral hygiene education and motivational support through an AI-based chatbot specifically developed for implant maintenance.
Control group: Received standard oral hygiene instructions through printed materials and sessions with a dental hygienist.
After the study, the chatbot was made available to the control group.
Outcome Measures:
The primary outcome was the Plaque Index (PI) at implant sites. Secondary outcomes included bleeding on probing (BOP), suppuration (SUP), probing pocket depth (PPD), and radiographic marginal bone loss (MBL).
Expected Impact:
This study aims to validate the use of AI-based educational tools as a complementary strategy for improving patient compliance, plaque control, and peri-implant health. The findings could support the safe and effective integration of AI chatbots into clinical dental practice and patient education programs.
- Being tested
- AI Chatbot, Standard Oral Hygiene Education
- Keywords
- Dental Implants, Oral Hygiene, Artificial Intelligence, Chatbot, Patient Education, Peri-Implant Diseases, Peri-Implantitis, Mucositis, Randomized Controlled Trial, Preventive Dentistry
- Medical subject headings
- Peri-Implantitis, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI ChatbotBehavioural
An artificial intelligence-based chatbot specifically designed and validated by dental experts to provide personalized oral hygiene education and motivational support.
Standard Oral Hygiene EducationBehavioural
Participants in the Control Group receive traditional oral hygiene education, including printed informational leaflets and scheduled sessions with a dental hygienist.
| Study group | Role | What they receive |
|---|---|---|
| Chatbot Group | Experimental | Participants receive oral hygiene education and motivational support through an AI-based chatbot developed and validated by dental professionals. Receives: Behavioral: AI Chatbot |
| Control Group | Active comparator | Participants receive standard oral hygiene education through printed informational leaflets and scheduled sessions with a dental hygienist. Receives: Behavioral: Standard Oral Hygiene Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Index (PI) Score at Implant Sites
The PI is considered a direct indicator of the quality of oral hygiene at home and reflects the level of plaque control achieved by each participant. Measurements will be recorded using a standard four-grade scale (0-3) at six sites per implant by a blinded examiner.
Measured: Baseline (prosthetic loading of implant) and 6 months after intervention start.
Secondary outcomes (3)
Presence of Bleeding on Probing (BOP) at Implant Sites
Bleeding on probing (BOP) is used to assess peri-implant tissue inflammation and is defined as the occurrence of bleeding immediately upon probe withdrawal. This parameter will be recorded at six sites per implant.
Measured: Baseline (prosthetic loading of implant) and 6 months after intervention start.
Presence of Suppuration on Probing (SUP) at Implant Sites
Suppuration (SUP) is used to assess peri-implant bacterial infection and is defined as the presence of pus upon probe withdrawal. SUP will be recorded at six sites per implant.
Measured: Baseline (prosthetic loading of implant) and 6 months after intervention start.
Marginal Bone Loss (MBL) in Millimeters at Implant Sites
Marginal bone loss (MBL) will be assessed radiographically at the mesial and distal aspects of each implant and measured in millimeters (mm) to evaluate peri-implant bone level changes over time using standardized periapical radiographs.
Measured: Baseline (prosthetic loading of implant) and 6 months after intervention start.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start1 Jun 2024
- Primary completion31 May 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-Implant MucositisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to either the AI-based chatbot intervention group or the standard oral hygiene education control group. Each participant receives only one intervention during the study. Randomization ensures balanced allocation and reduces selection bias.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Cicciù, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300657
- Sponsor's protocol ID
- Odonto-IA01
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) from this study, including clinical outcomes (Plaque Index, Bleeding on Probing, Probing Pocket Depth) and radiographic outcomes (Marginal Bone Loss), will be shared. Data will be provided in a format suitable for secondary analysis and will exclude any information that could directly identify participants.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Artificial Intelligence-Based Chatbot on Implant Patient Management: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07300657
- Acronym / sponsor ID
- Odonto-IA01
- Keywords
- Dental Implants, Oral Hygiene, Artificial Intelligence, Chatbot, Patient Education, Peri-Implant Diseases, Peri-Implantitis, Mucositis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 24 Dec 2025 (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.
Background: Dental implant therapy is a well-established and predictable procedure for replacing missing teeth, with high long-term survival rates. However, poor oral hygiene remains one of the main modifiable risk factors for peri-implant diseases such as mucositis and peri-implantitis.
Objective: The aim of this randomized controlled clinical trial is to evaluate the effectiveness of an artificial intelligence (AI)-based chatbot, developed and validated by dental experts, in improving oral hygiene and clinical outcomes in patients with implant-supported restorations, compared to traditional educational methods such as printed leaflets and dental hygienist sessions.
Methods: A total of 110 adult patients rehabilitated with dental implants were randomly assigned to either an AI chatbot intervention group or a control group receiving standard oral hygiene education. The chatbot provides continuous, personalized education and motivation through natural language interaction. Clinical and radiographic parameters, including plaque index (PI), bleeding on probing (BOP), probing pocket depth (PPD), and marginal bone loss (MBL), were recorded at baseline and at follow-up visits.
Expected outcomes: It is hypothesized that the use of an AI-based chatbot will significantly improve oral hygiene compliance and clinical outcomes compared to conventional methods.
Significance: The study aims to demonstrate the potential of AI-assisted patient education in promoting long-term peri-implant health and preventing peri-implant diseases.
Detailed description
Rationale and Background:
Dental implant therapy is highly successful, but peri-implant diseases, primarily caused by inadequate plaque control, remain a major cause of implant failure. Conventional oral hygiene education methods, such as verbal instructions and printed materials, often fail to ensure long-term patient compliance. Artificial intelligence (AI)-based chatbots, powered by large language models, offer a new way to provide continuous, personalized education and motivation to patients. Although their potential has been explored in orthodontics, little is known about their role in peri-implant maintenance.
Study Objective:
This randomized controlled clinical trial investigates whether an AI-based chatbot developed by dental experts can improve oral hygiene compliance and peri-implant health compared to traditional educational methods.
Study Design:
A total of 110 participants were enrolled between June 2024 and June 2025 in private dental practices in Catania, Italy. The study was approved by the local ethics committee (Protocol ID: 60/2024/CL-PAR) and conducted in accordance with the Declaration of Helsinki (2016 revision). Eligible participants were adults (≥18 years), systemically healthy or with controlled conditions, attending regular supportive periodontal therapy, and having at least one osseointegrated implant. Exclusion criteria included active periodontal disease, heavy smoking, systemic immunosuppression, and pregnancy.
Interventions:
Participants were randomly assigned to two groups:
Chatbot group: Received oral hygiene education and motivational support through an AI-based chatbot specifically developed for implant maintenance.
Control group: Received standard oral hygiene instructions through printed materials and sessions with a dental hygienist.
After the study, the chatbot was made available to the control group.
Outcome Measures:
The primary outcome was the Plaque Index (PI) at implant sites. Secondary outcomes included bleeding on probing (BOP), suppuration (SUP), probing pocket depth (PPD), and radiographic marginal bone loss (MBL).
Expected Impact:
This study aims to validate the use of AI-based educational tools as a complementary strategy for improving patient compliance, plaque control, and peri-implant health. The findings could support the safe and effective integration of AI chatbots into clinical dental practice and patient education programs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to either the AI-based chatbot intervention group or the standard oral hygiene education control group. Each participant receives only one intervention during the study. Randomization ensures balanced allocation and reduces selection bias.
| Arm | Type | Receives |
|---|---|---|
| Chatbot Group | Experimental | Behavioral: AI ChatbotParticipants receive oral hygiene education and motivational support through an AI-based chatbot developed and validated by dental professionals. |
| Control Group | Active comparator | Behavioral: Standard Oral Hygiene EducationParticipants receive standard oral hygiene education through printed informational leaflets and scheduled sessions with a dental hygienist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Systemically healthy or with controlled systemic conditions;
- Good periodontal health on either an intact or reduced periodontium;
- Regular adherence to supportive periodontal therapy (SPT);
- Presence of at least one osseointegrated dental implant in the maxilla or mandible, following transmucosal healing for 2-4 months;
- Daily access to a smartphone.
Key exclusion criteria (8 listed)
- Age < 18 years;
- Untreated or active periodontal disease;
- Currently undergoing orthodontic therapy;
- Patients with cognitive deficits;
- Smoking habit (more than 10 cigarettes per day);
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 |
|---|---|---|
| AI ChatbotAn artificial intelligence-based chatbot specifically designed and validated by dental experts to provide personalized oral hygiene education and motivational support. | Behavioural | Chatbot Group |
| Standard Oral Hygiene EducationParticipants in the Control Group receive traditional oral hygiene education, including printed informational leaflets and scheduled sessions with a dental hygienist. | Behavioural | Control Group |
Primary outcome
Plaque Index (PI) Score at Implant Sites
Time frame: Baseline (prosthetic loading of implant) and 6 months after intervention start.
The PI is considered a direct indicator of the quality of oral hygiene at home and reflects the level of plaque control achieved by each participant. Measurements will be recorded using a standard four-grade scale (0-3) at six sites per implant by a blinded examiner.
3 secondary outcomes
Presence of Bleeding on Probing (BOP) at Implant Sites
Time frame: Baseline (prosthetic loading of implant) and 6 months after intervention start.
Presence of Suppuration on Probing (SUP) at Implant Sites
Time frame: Baseline (prosthetic loading of implant) and 6 months after intervention start.
Marginal Bone Loss (MBL) in Millimeters at Implant Sites
Time frame: Baseline (prosthetic loading of implant) and 6 months after intervention start.
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 24 Dec 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) from this study, including clinical outcomes (Plaque Index, Bleeding on Probing, Probing Pocket Depth) and radiographic outcomes (Marginal Bone Loss), will be shared. Data will be provided in a format suitable for secondary analysis and will exclude any information that could directly identify participants.
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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?
A study testing AI Chatbot and Standard Oral Hygiene Education in people with Peri-Implant Mucositis and Peri-implantitis, run by University of Catania at 1 site in Italy.
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 8 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 24 Dec 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 Italy. 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?
Plaque Index (PI) Score at Implant Sites (time frame: Baseline (prosthetic loading of implant) and 6 months after intervention start.). 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 24 Dec 2025.