Periodontal DiseasesSALIENCENCT07254039
AI-Assisted Saliva Diagnostics Using an Electrochemical Sensor Platform for Periodontitis Detection (SALIENCE)
An observational study of Periodontal Diseases and Biomarkers (D23.050.301), run by Ostergotland County Council, Sweden.
Trial summary
This observational study aims to develop and validate a novel, AI-assisted electrochemical sensor platform for saliva-based diagnostics in periodontitis. Periodontitis is a chronic inflammatory disease affecting the gums and supporting tissues of the teeth. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Biomarkers (D23.050.301), Diagnostic
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 30 Jun 2028
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult participants (≥18 years) will be recruited from an affiliated dental clinic. The study population consists of two groups: (1) patients clinically diagnosed with periodontitis according to the 2018 AAP/EFP classification, and (2) periodontally healthy adults with no signs of periodontal disease. All participants must be able to provide informed consent and a saliva sample according to study protocol.
Who may be able to join
- Adults ≥18 years.
- Able and willing to provide written informed consent.
- Ability to provide an unstimulated whole saliva sample per protocol (no food, drink, gum, toothbrushing, or smoking within 60 minutes prior to sampling).
- Periodontitis group: Clinical diagnosis of periodontitis according to 2018 AAP/EFP criteria (e.g., interdental CAL ≥3 mm at ≥2 non-adjacent teeth with radiographic bone loss; probing pocket depth ≥4 mm in ≥2 teeth).
- Healthy control group: No clinical signs of periodontal disease (no probing depths >3 mm, bleeding on probing <10%, and no radiographic bone loss).
Who cannot join
- Systemic antibiotics or systemic anti-inflammatory/immunosuppressive therapy within the past 3 months.
- Periodontal therapy (scaling/root planing or surgery) within the past 6 months.
- Current acute oral infection or abscess.
- Systemic conditions known to markedly alter saliva composition/flow (e.g., Sjögren's syndrome, prior head-and-neck radiation, ongoing chemotherapy, uncontrolled diabetes).
- Use of strongly xerogenic medications not on a stable dose ≥4 weeks, or clinically significant hyposalivation preventing sampling.
- Inability to comply with sampling procedures (e.g., cannot abstain from food/drink/tobacco for 60 minutes prior to sampling).
- Pregnancy or lactation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Development and Validation of an AI-Assisted Electrochemical Sensor Platform for Saliva-Based Diagnostics in Periodontitis
This observational study aims to develop and validate a novel, AI-assisted electrochemical sensor platform for saliva-based diagnostics in periodontitis. Periodontitis is a chronic inflammatory disease affecting the gums and supporting tissues of the teeth. Despite its high global prevalence, early diagnosis remains challenging because the disease often progresses silently until irreversible damage has occurred.
Saliva offers a promising, non-invasive diagnostic medium that reflects both oral and systemic health. However, its biological complexity and variability have limited its clinical use. This project addresses these challenges by combining advanced electrochemical sensing with artificial intelligence (AI) and synthetic data generation to improve diagnostic precision and reliability.
Read more
The study involves the collection of saliva samples from adult participants with diagnosed periodontitis and from healthy controls. The samples will be analyzed using a modular sensor platform equipped with multiple electrodes that detect electrochemical signals from a wide range of salivary biomarkers. The sensor data will then be processed using machine learning models trained on both real and synthetic data to classify disease states.
The main goals are to:
Evaluate the performance of the electrochemical sensor array for saliva analysis.
Develop and validate AI-based algorithms for detecting and differentiating between healthy and diseased samples.
Generate feasibility data supporting future clinical implementation of saliva-based diagnostics for periodontitis.
This interdisciplinary project combines expertise in clinical dentistry, biomedical engineering, and computer science. It is conducted in collaboration between Linköping University and Malmö University, with patient sampling carried out at an affiliated dental clinic.
The study is expected to result in a working proof-of-concept device that enables real-time, non-invasive detection of periodontitis at the point of care. By enabling earlier diagnosis and more personalized treatment, this technology may transform periodontal care and serve as a foundation for future saliva-based diagnostics targeting other oral and systemic diseases.
Read the detailed description
Background and Rationale Periodontitis is a chronic inflammatory disease that affects the supporting tissues of the teeth and is one of the most prevalent oral diseases worldwide. Despite its high prevalence, early diagnosis remains a major challenge, as current diagnostic tools rely on retrospective measures such as pocket depth, bleeding on probing, and radiographic bone loss. These indicators reflect past tissue destruction rather than current disease activity, leading to delayed diagnosis and treatment.
Saliva is an attractive diagnostic fluid for non-invasive, real-time disease monitoring because it contains a complex mixture of biomarkers that reflect both oral and systemic health. However, its biological variability, matrix effects, and susceptibility to contamination have limited its reliability as a diagnostic medium. To overcome these challenges, this project integrates electrochemical sensing with artificial intelligence (AI)-driven data interpretation and synthetic data generation to enable robust saliva-based diagnostics.
Study Objectives
The overall objective is to develop and validate an AI-assisted electrochemical sensor platform capable of detecting biochemical patterns in saliva associated with periodontitis. Specific aims are to:
Design and optimize a modular, multi-electrode sensor platform for saliva analysis.
Develop and validate AI algorithms for real-time signal interpretation and disease classification.
Generate feasibility and proof-of-concept data for future clinical implementation in dental care.
Study Design and Methods This is an observational study involving saliva sampling from adult participants diagnosed with periodontitis and healthy control subjects. Approximately 25 periodontitis patients and an expanded control group will be recruited from a collaborating dental clinic.
The electrochemical sensor platform will include multiple electrode types (carbon, gold, platinum, palladium), each selected for specific electrochemical and biochemical properties. The electrodes will detect a broad spectrum of salivary biomarkers, including metabolites related to inflammation, oxidative stress, and microbial activity. The system supports several analytical modes, such as differential pulse voltammetry (DPV), which provides high sensitivity and resolution across multiple analytes.
Collected saliva samples will first be tested under controlled laboratory conditions to establish baseline sensor responses. Selected samples will also undergo complementary analyses (e.g., H-NMR, LC-MS) for calibration and validation. Sensor signals will be processed and classified using supervised and unsupervised machine learning models, including support vector machines and random forests. Synthetic data augmentation, based on generative models such as variational autoencoders, will be used to increase dataset diversity and improve model generalization, particularly in the early phase when sample numbers are limited.
Implementation Plan The project is organized over 24 months, beginning in September 2025.
Months 1-4: Selection and benchmarking of electrode materials in artificial and healthy saliva samples.
Months 5-8: Assembly of the first prototype with integrated AI signal acquisition and secure, GDPR-compliant data transmission.
Months 9-12: Development of synthetic datasets and initial training of machine learning models.
Months 9-19: Clinical saliva sampling and iterative model refinement using new data.
Months 21-24: Real-world testing of the proof-of-concept system in a clinical setting, data analysis, and dissemination of results.
Data Handling and Analysis All collected data will be de-identified and processed according to GDPR and ethical standards. Sensor outputs will be linked to anonymized clinical metadata. Machine learning models will be evaluated based on classification accuracy, sensitivity, specificity, and robustness to biological variability. Statistical analyses will include cross-validation and performance benchmarking across electrode configurations and AI models.
Expected Outcomes and Significance The study will result in a functional proof-of-concept prototype of an AI-assisted saliva diagnostic system. The platform aims to provide rapid, non-invasive detection of periodontitis at the point of care. If successful, it will represent a paradigm shift in periodontal diagnostics, enabling earlier detection, better-targeted interventions, and improved patient outcomes.
Beyond periodontitis, the modular design of the system allows adaptation for other diseases, including oral cancer, systemic inflammation, and metabolic disorders. This flexibility enhances its long-term potential as a scalable diagnostic technology for both dental and medical applications.
Ethical Considerations and Risk Management The study has been approved by the Swedish Ethical Review Authority (reference number: 2025-04853-01). All participants will provide written informed consent prior to sample collection. The study involves minimal risk, limited to the discomfort associated with saliva sampling. No experimental treatment or invasive procedures will be performed.
Potential technical risks, such as variability in saliva samples or device performance, will be mitigated through standardized sampling protocols and iterative prototype refinement. The modular hardware design ensures that individual components can be adjusted or replaced without compromising the overall system.
Collaboration and Expertise This interdisciplinary project brings together experts in clinical dentistry, biomedical engineering, and computer science. The study is led by Assoc. Prof. Shariel Sayardoust (Linköping University and Östergötland County), with collaborators Assoc. Prof. Magnus Falk, Assoc. Prof. Julia Davies, and Dr. Erdal Akin from Malmö University. Industrial collaboration with Redoxme AB supports hardware prototyping and integration.
Together, the consortium aims to establish the foundation for next-generation saliva diagnostics that combine AI, electrochemical sensing, and patient-centered care in everyday clinical practice.
- Conditions
- Periodontal Diseases, Biomarkers (D23.050.301), Diagnostic, Saliva
- Keywords
- Saliva Diagnostics, Electrochemical Sensor, AI-Assisted Diagnostics, Biomarkers, Periodontal diseases
- Medical subject headings
- Periodontal Diseases, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Periodontitis Group | Adults diagnosed with periodontitis based on clinical criteria. | |
| Healthy Control Group | Adults with no clinical signs of periodontal disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of the AI-Assisted Electrochemical Saliva Sensor for Detecting Periodontitis
This outcome assesses the diagnostic accuracy of the AI-assisted electrochemical sensor platform by calculating sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and the area under the receiver operating characteristic curve (AUC). The platform analyzes electrochemical signal patterns in saliva samples, and an AI-based classification model predicts whether participants have periodontitis.
Clinical periodontal status (periodontitis vs. periodontal health) will be established using a full-mouth clinical examination according to the 2017 World Workshop classification criteria. Diagnostic accuracy metrics from the sensor platform will be compared against this clinical gold standard.
Measured: Within 24 months after study start (end of data collection and analysis).
Secondary outcomes (3)
Within-Run Repeatability of Electrochemical Saliva Sensor Signals (Coefficient of Variation)
This outcome will assess the within-run repeatability of electrochemical signal measurements generated by the sensor array when analyzing saliva samples. Repeatability will be quantified using the coefficient of variation (CV%) calculated from multiple consecutive measurements of the same saliva sample under standardized laboratory conditions.
Measured: Measured throughout the 24-month study period.
Correlation Between Sensor Outputs and Biochemical Reference Analyses
To evaluate the correlation between electrochemical sensor responses and conventional biochemical or molecular reference methods (e.g., LC-MS, H-NMR) for validation of analytical accuracy.
Measured: 24 month
System Usability Scale (SUS) Score for Clinical Use of the AI-Assisted Saliva Sensor Platform
Feasibility of clinical implementation will be evaluated using the System Usability Scale (SUS), a validated 10-item questionnaire that provides a global usability score from 0 to 100. The SUS score will assess perceived usability, learnability, and integration into dental workflow among clinical staff using the AI-assisted saliva sensor platform. Higher scores indicate better usability and feasibility for routine clinical implementation.
The SUS score will be summarized using mean and standard deviation.
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (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.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ostergotland County Council, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Malmö University, Linkoeping University
- Responsible party
- Principal investigator, Shariel Sayardoust, Ostergotland County Council, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254039
- Sponsor's protocol ID
- SALIENCE2025
- Acronym
- SALIENCE
- Status last verified
- Oct 2025
- First submitted
- 15 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of an AI-Assisted Electrochemical Sensor Platform for Saliva-Based Diagnostics in Periodontitis
- ClinicalTrials.gov ID
- NCT07254039
- Acronym / sponsor ID
- SALIENCE / SALIENCE2025
- Conditions
- Periodontal Diseases, Biomarkers (D23.050.301), Diagnostic, Saliva
- Keywords
- Saliva Diagnostics, Electrochemical Sensor, AI-Assisted Diagnostics, Biomarkers, Periodontal diseases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ostergotland County Council, SwedenUniversity, hospital or other
- Collaborators
- Malmö University, Linkoeping University
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 28 Nov 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.
This observational study aims to develop and validate a novel, AI-assisted electrochemical sensor platform for saliva-based diagnostics in periodontitis. Periodontitis is a chronic inflammatory disease affecting the gums and supporting tissues of the teeth. Despite its high global prevalence, early diagnosis remains challenging because the disease often progresses silently until irreversible damage has occurred.
Saliva offers a promising, non-invasive diagnostic medium that reflects both oral and systemic health. However, its biological complexity and variability have limited its clinical use. This project addresses these challenges by combining advanced electrochemical sensing with artificial intelligence (AI) and synthetic data generation to improve diagnostic precision and reliability.
The study involves the collection of saliva samples from adult participants with diagnosed periodontitis and from healthy controls. The samples will be analyzed using a modular sensor platform equipped with multiple electrodes that detect electrochemical signals from a wide range of salivary biomarkers. The sensor data will then be processed using machine learning models trained on both real and synthetic data to classify disease states.
The main goals are to:
Evaluate the performance of the electrochemical sensor array for saliva analysis.
Develop and validate AI-based algorithms for detecting and differentiating between healthy and diseased samples.
Generate feasibility data supporting future clinical implementation of saliva-based diagnostics for periodontitis.
This interdisciplinary project combines expertise in clinical dentistry, biomedical engineering, and computer science. It is conducted in collaboration between Linköping University and Malmö University, with patient sampling carried out at an affiliated dental clinic.
The study is expected to result in a working proof-of-concept device that enables real-time, non-invasive detection of periodontitis at the point of care. By enabling earlier diagnosis and more personalized treatment, this technology may transform periodontal care and serve as a foundation for future saliva-based diagnostics targeting other oral and systemic diseases.
Detailed description
Background and Rationale Periodontitis is a chronic inflammatory disease that affects the supporting tissues of the teeth and is one of the most prevalent oral diseases worldwide. Despite its high prevalence, early diagnosis remains a major challenge, as current diagnostic tools rely on retrospective measures such as pocket depth, bleeding on probing, and radiographic bone loss. These indicators reflect past tissue destruction rather than current disease activity, leading to delayed diagnosis and treatment.
Saliva is an attractive diagnostic fluid for non-invasive, real-time disease monitoring because it contains a complex mixture of biomarkers that reflect both oral and systemic health. However, its biological variability, matrix effects, and susceptibility to contamination have limited its reliability as a diagnostic medium. To overcome these challenges, this project integrates electrochemical sensing with artificial intelligence (AI)-driven data interpretation and synthetic data generation to enable robust saliva-based diagnostics.
Study Objectives
The overall objective is to develop and validate an AI-assisted electrochemical sensor platform capable of detecting biochemical patterns in saliva associated with periodontitis. Specific aims are to:
Design and optimize a modular, multi-electrode sensor platform for saliva analysis.
Develop and validate AI algorithms for real-time signal interpretation and disease classification.
Generate feasibility and proof-of-concept data for future clinical implementation in dental care.
Study Design and Methods This is an observational study involving saliva sampling from adult participants diagnosed with periodontitis and healthy control subjects. Approximately 25 periodontitis patients and an expanded control group will be recruited from a collaborating dental clinic.
The electrochemical sensor platform will include multiple electrode types (carbon, gold, platinum, palladium), each selected for specific electrochemical and biochemical properties. The electrodes will detect a broad spectrum of salivary biomarkers, including metabolites related to inflammation, oxidative stress, and microbial activity. The system supports several analytical modes, such as differential pulse voltammetry (DPV), which provides high sensitivity and resolution across multiple analytes.
Collected saliva samples will first be tested under controlled laboratory conditions to establish baseline sensor responses. Selected samples will also undergo complementary analyses (e.g., H-NMR, LC-MS) for calibration and validation. Sensor signals will be processed and classified using supervised and unsupervised machine learning models, including support vector machines and random forests. Synthetic data augmentation, based on generative models such as variational autoencoders, will be used to increase dataset diversity and improve model generalization, particularly in the early phase when sample numbers are limited.
Implementation Plan The project is organized over 24 months, beginning in September 2025.
Months 1-4: Selection and benchmarking of electrode materials in artificial and healthy saliva samples.
Months 5-8: Assembly of the first prototype with integrated AI signal acquisition and secure, GDPR-compliant data transmission.
Months 9-12: Development of synthetic datasets and initial training of machine learning models.
Months 9-19: Clinical saliva sampling and iterative model refinement using new data.
Months 21-24: Real-world testing of the proof-of-concept system in a clinical setting, data analysis, and dissemination of results.
Data Handling and Analysis All collected data will be de-identified and processed according to GDPR and ethical standards. Sensor outputs will be linked to anonymized clinical metadata. Machine learning models will be evaluated based on classification accuracy, sensitivity, specificity, and robustness to biological variability. Statistical analyses will include cross-validation and performance benchmarking across electrode configurations and AI models.
Expected Outcomes and Significance The study will result in a functional proof-of-concept prototype of an AI-assisted saliva diagnostic system. The platform aims to provide rapid, non-invasive detection of periodontitis at the point of care. If successful, it will represent a paradigm shift in periodontal diagnostics, enabling earlier detection, better-targeted interventions, and improved patient outcomes.
Beyond periodontitis, the modular design of the system allows adaptation for other diseases, including oral cancer, systemic inflammation, and metabolic disorders. This flexibility enhances its long-term potential as a scalable diagnostic technology for both dental and medical applications.
Ethical Considerations and Risk Management The study has been approved by the Swedish Ethical Review Authority (reference number: 2025-04853-01). All participants will provide written informed consent prior to sample collection. The study involves minimal risk, limited to the discomfort associated with saliva sampling. No experimental treatment or invasive procedures will be performed.
Potential technical risks, such as variability in saliva samples or device performance, will be mitigated through standardized sampling protocols and iterative prototype refinement. The modular hardware design ensures that individual components can be adjusted or replaced without compromising the overall system.
Collaboration and Expertise This interdisciplinary project brings together experts in clinical dentistry, biomedical engineering, and computer science. The study is led by Assoc. Prof. Shariel Sayardoust (Linköping University and Östergötland County), with collaborators Assoc. Prof. Magnus Falk, Assoc. Prof. Julia Davies, and Dr. Erdal Akin from Malmö University. Industrial collaboration with Redoxme AB supports hardware prototyping and integration.
Together, the consortium aims to establish the foundation for next-generation saliva diagnostics that combine AI, electrochemical sensing, and patient-centered care in everyday clinical practice.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontitis Group | – | –Adults diagnosed with periodontitis based on clinical criteria. |
| Healthy Control Group | – | –Adults with no clinical signs of periodontal disease. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants (≥18 years) will be recruited from an affiliated dental clinic. The study population consists of two groups: (1) patients clinically diagnosed with periodontitis according to the 2018 AAP/EFP classification, and (2) periodontally healthy adults with no signs of periodontal disease. All participants must be able to provide informed consent and a saliva sample according to study protocol.
Key inclusion criteria (5 listed)
- Adults ≥18 years.
- Able and willing to provide written informed consent.
- Ability to provide an unstimulated whole saliva sample per protocol (no food, drink, gum, toothbrushing, or smoking within 60 minutes prior to sampling).
- Periodontitis group: Clinical diagnosis of periodontitis according to 2018 AAP/EFP criteria (e.g., interdental CAL ≥3 mm at ≥2 non-adjacent teeth with radiographic bone loss; probing pocket depth ≥4 mm in ≥2 teeth).
- Healthy control group: No clinical signs of periodontal disease (no probing depths >3 mm, bleeding on probing <10%, and no radiographic bone loss).
Key exclusion criteria (7 listed)
- Systemic antibiotics or systemic anti-inflammatory/immunosuppressive therapy within the past 3 months.
- Periodontal therapy (scaling/root planing or surgery) within the past 6 months.
- Current acute oral infection or abscess.
- Systemic conditions known to markedly alter saliva composition/flow (e.g., Sjögren's syndrome, prior head-and-neck radiation, ongoing chemotherapy, uncontrolled diabetes).
- Use of strongly xerogenic medications not on a stable dose ≥4 weeks, or clinically significant hyposalivation preventing sampling.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity and Specificity of the AI-Assisted Electrochemical Saliva Sensor for Detecting Periodontitis
Time frame: Within 24 months after study start (end of data collection and analysis).
This outcome assesses the diagnostic accuracy of the AI-assisted electrochemical sensor platform by calculating sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and the area under the receiver operating characteristic curve (AUC). The platform analyzes electrochemical signal patterns in saliva samples, and an AI-based classification model predicts whether participants have periodontitis. Clinical periodontal status (periodontitis vs. periodontal health) will be established using a full-mouth clinical examination according to the 2017 World Workshop classification criteria. Diagnostic accuracy metrics from the sensor platform will be compared against this clinical gold standard.
3 secondary outcomes
Within-Run Repeatability of Electrochemical Saliva Sensor Signals (Coefficient of Variation)
Time frame: Measured throughout the 24-month study period.
Correlation Between Sensor Outputs and Biochemical Reference Analyses
Time frame: 24 month
System Usability Scale (SUS) Score for Clinical Use of the AI-Assisted Saliva Sensor Platform
Time frame: 24 month
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 28 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases and Biomarkers (D23.050.301), run by Ostergotland County Council, Sweden.
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 7 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: opening soon, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
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 Shariel Sayardoust, DDS., PhD (+46736564648, shariel.sayardoust@regionostergotland.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of the AI-Assisted Electrochemical Saliva Sensor for Detecting Periodontitis (time frame: Within 24 months after study start (end of data collection and analysis).). 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 Nov 2025.