Periodontitis Stage IIINCT07426224
Blood Glucose Screening in Patients With Advanced Periodontits: the Role of Specialist Periodontal Care in Identifying Hyperglycaemia and Supporting Patient Centered Treatment
An observational study of Periodontitis Stage III and Periodontitis Stage IV, run by Folktandvården Stockholms län AB at 1 site in Sweden.
Trial summary
Periodontitis is a chronic inflammatory disease and individuals with advanced periodontitis have an increased risk of hyperglycaemia. Bacterial plaque, smoking and elevated blood glucose levels are considered key modifiable risk factors for periodontal disease progression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis Stage III, Periodontitis Stage IV, Diabetes (DM)
- What is being tested?
- Selective screening of blood glucose/HbA1c
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- 13 Mar 2026to 31 Dec 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients referred for evaluation and treatment of periodontitis at the specialist clinic Folktandvarden Eastmaninstitutet who, following a full periodontal examination and radiographic assessment, are classified as having Stage III or Stage IV periodontitis according to current international criteria.
Who may be able to join
- adult patients >18 years
- classified as having Stage III or Stage IV periodontitis (according to current international criteria)
Who cannot join
- Patients who are unable to provide informed consent because of significant cognitive impairment or unable to understand written and spoken Swedish
- Patients with periodontitis as a manifestation of systemic disease or syndrome
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Blodsockermätning Vid Avancerad Parodontit; så Kan specialisttandvården Identifiera Hyperglykemi Och Bidra Till Individanpassad vård
Periodontitis is a chronic inflammatory disease and individuals with advanced periodontitis have an increased risk of hyperglycaemia. Bacterial plaque, smoking and elevated blood glucose levels are considered key modifiable risk factors for periodontal disease progression. Conventional periodontal care aims to remove and control bacterial deposits and to smoking cessation. Despite the bidirectional relationship, where periodontitis may also contribute to impaired glycaemic control, glycaemic status is rarely niether assessed nor adressed in dental care.
The aim of this project is to implement and evaluate routine blood glucose testing as part of the periodontal examination in specialist dental care. Patients diagnosed with advanced periodontitis (Stage III or IV according to the current classification) will be offered capillary blood glucose testing during their periodontal assessment.
The objectives of this study are to determine the prevalence of hyperglycaemia among patients with advanced periodontitis and to evaluate clinician-reported and patient-reported experiences of routine blood glucose testing as part of the periodontal assesment in specialist periodontal care.
Read the detailed description
Periodontitis is a chronic inflammatory disease affecting the supporting structures of the teeth and represents one of the most prevalent non-communicable diseases worldwide. Epidemiological studies show that population-level preventive strategies targeting dental biofilm control and smoking cessation have contributed to improvements in periodontal health, these measures have not resulted in a significant reduction in the prevalence of advanced periodontitis over the last decades. Individuals who develop severe and rapidly progressing periodontal disease have an increased susceptibility to plaque induced inflammation and hyperglycemia seem to play a central role as a modifyer of that susceptability.
A bidirectional relationship between hyperglycemia and periodontitis has been well established. Elevated blood glucose levels are associated with increased risk of periodontal tissue breakdown, impaired wound healing and accelerated disease progression, while periodontal inflammation may affect glycemic control. Hyperglycemia is therefore not only a systemic health concern but also a clinically relevant, modifiable risk factor that directly influences periodontal prognosis. Contemporary periodontal classification systems explicitly incorporate glycemic status into disease grading, emphasizing the importance of identifying and addressing this risk factor in patients with advanced disease.
Despite this recognized relationship, routine assessment of glycemic status is rarely performed in dental settings in Sweden, largely due to the absence of established protocols and access to point-of-care testing. This represents a missed opportunity, particularly within specialist periodontal care, where patients with Stage III and IV periodontitis are identified through comprehensive periodontal examinations. A substantial proportion of individuals with type 2 diabetes or prediabetes remain undiagnosed, and many of these individuals may seek dental care more regularly than medical care. Specialist periodontal clinics may therefore serve as a valuable setting for selective screening of hyperglycemia in a clearly defined high-risk population.
The present study aims to integrate capillary HbA1c testing as a routine in periodontal assessment within specialist dental care and to evaluate its ability to identify previously unrecognized hyperglycemia or suboptimal glycemic control as well as investigate the the patients and dentists experience of that routine. The study is designed as a cross-sectional observational investigation conducted at the Department of Periodontology, Eastman Institute, Stockholm, over a 12-month period.
Eligible participants are adult patients referred for evaluation and treatment of periodontitis who, following a full periodontal examination and radiographic assessment, are classified as having Stage III or Stage IV periodontitis according to current classification criteria. Patients who are unable to provide informed consent, have cognitive impairment or present with periodontitis as a manifestation of systemic disease or syndrome are excluded. To ensure informed participation, only patients able to understand written and spoken Swedish are included.
Following confirmation of eligibility, patients are provided with oral and written information about the study and written informed consent is obtained. Capillary blood sampling is performed using a finger-prick method with a single-use lancet, and HbA1c is analyzed chair-side using a validated point-of-care device. The test does not require fasting or other patient preparation and is conducted in direct conjunction with the periodontal examination. The biological sample is not stored; only the test result is recorded in the patient's dental record.
Participants receive individualized feedback regarding their HbA1c result. For patients without a known diagnosis of diabetes who present with HbA1c values above the predefined threshold indicating hyperglycemia, information is provided regarding the potential risk of diabetes or prediabetes, and the patient is advised to contact primary care for further medical evaluation. Patients with known diabetes who exhibit HbA1c values indicating suboptimal glycemic control are encouraged to consult their diabetes care provider. In all cases, it is clearly communicated that the dental assessment does not constitute a medical diagnosis but serves as an indication warranting further evaluation.
In addition to HbA1c, clinical data are collected, including age, sex, smoking status, number of remaining teeth, bleeding on probing, number of periodontal pockets ≥6 mm, furcation involvement, and periodontal classification. These variables enables interpretation of glycemic findings in relation to periodontal disease severity. All data are recorded in a pseudonymized format for statistical analysis.
To capture the experience of the routine, patients are asked to complete a brief questionnaire assessing perceived meaningfulness associated with the blood sampling procedure. Dental staff involved in the procedure similarly assess perceived meaningfulness and time requirements. These qualitative measures provide insight into the practicality of implementing glycemic screening as a routine of specialist periodontal care.
The primary outcome measure is HbA1c expressed in mmol/mol, analyzed as a continuous variable and categorized according to established clinical thresholds. Secondary outcomes include the prevalence of previously undetected hyperglycemia among patients without known diabetes and the prevalence of inadequate glycemic control among patients with known diabetes. Descriptive statistical analyses are used to summarize HbA1c distributions and prevalence estimates in relation to periodontal characteristics. All analyses are conducted on pseudonymized datasets, and results are reported in aggregate form.
From an ethical perspective, the study is considered low risk. The capillary blood sampling procedure is minimally invasive and widely used in routine healthcare. Potential psychological discomfort related to identification of elevated HbA1c values is acknowledged; however, this risk is weighed against the benefit of early detection of hyperglycemia and the prevention of long-term diabetes-related complications. Selective screening restricted to patients with objectively verified advanced periodontitis is intended to reduce the risk of unnecessary referrals.
Personal data are handled in accordance with data protection regulations and guidelines. Identifiable data are stored securely within authorized clinical systems, while research datasets used for analysis are pseudonymized. No biological material is stored after analysis. Responsibility for data processing lies with the healthcare provider, and all research documentation is archived in accordance with institutional record-keeping requirements.
By integrating glycemic assessment into specialist periodontal evaluation, this study explores a model for interdisciplinary prevention that aligns oral health care with broader public health objectives. The findings are expected to inform future clinical routines and contribute to the development of evidence-based protocols for selective metabolic screening within dental specialist settings.
- Conditions
- Periodontitis Stage III, Periodontitis Stage IV, Diabetes (DM), Prediabetes, Hyperglycaemia
- Being tested
- Selective screening of blood glucose/HbA1c
- Keywords
- Periodontitis stage IV, Periodontitis stage III, Diabetes, Prediabetes, Hyperglycaemia, Screening
- Medical subject headings
- Periodontitis, Diabetes Mellitus, Prediabetic State, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective screening of blood glucose/HbA1cOther
Selective screening for hyperglycaemia in dental setting is a new routine that has not been introduced in Folktandvården Stockholm.
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c mmol/mol
The primary outcome measure is HbA1c expressed in mmol/mol, analyzed as a continuous variable and categorized according to established clinical thresholds. Descriptive statistical analyses are used to summarize HbA1c distributions and prevalence estimates in relation to periodontal characteristics.
Measured: The bloodsampling is done chair-side and is analysed immediatley with a Point-of-Care device meaning the procedure is limited to maximum 5 minutes.
Secondary outcomes (1)
Hyperglycaemia
Prevalence of previously undetected hyperglycemia among patients without known diabetes and the prevalence of inadequate glycemic control among patients with known diabetes
Measured: As previously described, for the patients the capillary bloodsample is collected and analyzed in maximum 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start13 Mar 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis Stage IIIStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Folktandvården Stockholms län AB
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426224
- Sponsor's protocol ID
- FTV 2510-0527
- Status last verified
- May 2026
- First submitted
- 16 Feb 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blodsockermätning Vid Avancerad Parodontit; så Kan specialisttandvården Identifiera Hyperglykemi Och Bidra Till Individanpassad vård
- ClinicalTrials.gov ID
- NCT07426224
- Acronym / sponsor ID
- FTV 2510-0527
- Conditions
- Periodontitis Stage III, Periodontitis Stage IV, Diabetes (DM), Prediabetes, Hyperglycaemia
- Keywords
- Periodontitis stage IV, Periodontitis stage III, Diabetes, Prediabetes, Hyperglycaemia, Screening
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Folktandvården Stockholms län ABOther government
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Feb 2026 (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.
Periodontitis is a chronic inflammatory disease and individuals with advanced periodontitis have an increased risk of hyperglycaemia. Bacterial plaque, smoking and elevated blood glucose levels are considered key modifiable risk factors for periodontal disease progression. Conventional periodontal care aims to remove and control bacterial deposits and to smoking cessation. Despite the bidirectional relationship, where periodontitis may also contribute to impaired glycaemic control, glycaemic status is rarely niether assessed nor adressed in dental care.
The aim of this project is to implement and evaluate routine blood glucose testing as part of the periodontal examination in specialist dental care. Patients diagnosed with advanced periodontitis (Stage III or IV according to the current classification) will be offered capillary blood glucose testing during their periodontal assessment.
The objectives of this study are to determine the prevalence of hyperglycaemia among patients with advanced periodontitis and to evaluate clinician-reported and patient-reported experiences of routine blood glucose testing as part of the periodontal assesment in specialist periodontal care.
Detailed description
Periodontitis is a chronic inflammatory disease affecting the supporting structures of the teeth and represents one of the most prevalent non-communicable diseases worldwide. Epidemiological studies show that population-level preventive strategies targeting dental biofilm control and smoking cessation have contributed to improvements in periodontal health, these measures have not resulted in a significant reduction in the prevalence of advanced periodontitis over the last decades. Individuals who develop severe and rapidly progressing periodontal disease have an increased susceptibility to plaque induced inflammation and hyperglycemia seem to play a central role as a modifyer of that susceptability.
A bidirectional relationship between hyperglycemia and periodontitis has been well established. Elevated blood glucose levels are associated with increased risk of periodontal tissue breakdown, impaired wound healing and accelerated disease progression, while periodontal inflammation may affect glycemic control. Hyperglycemia is therefore not only a systemic health concern but also a clinically relevant, modifiable risk factor that directly influences periodontal prognosis. Contemporary periodontal classification systems explicitly incorporate glycemic status into disease grading, emphasizing the importance of identifying and addressing this risk factor in patients with advanced disease.
Despite this recognized relationship, routine assessment of glycemic status is rarely performed in dental settings in Sweden, largely due to the absence of established protocols and access to point-of-care testing. This represents a missed opportunity, particularly within specialist periodontal care, where patients with Stage III and IV periodontitis are identified through comprehensive periodontal examinations. A substantial proportion of individuals with type 2 diabetes or prediabetes remain undiagnosed, and many of these individuals may seek dental care more regularly than medical care. Specialist periodontal clinics may therefore serve as a valuable setting for selective screening of hyperglycemia in a clearly defined high-risk population.
The present study aims to integrate capillary HbA1c testing as a routine in periodontal assessment within specialist dental care and to evaluate its ability to identify previously unrecognized hyperglycemia or suboptimal glycemic control as well as investigate the the patients and dentists experience of that routine. The study is designed as a cross-sectional observational investigation conducted at the Department of Periodontology, Eastman Institute, Stockholm, over a 12-month period.
Eligible participants are adult patients referred for evaluation and treatment of periodontitis who, following a full periodontal examination and radiographic assessment, are classified as having Stage III or Stage IV periodontitis according to current classification criteria. Patients who are unable to provide informed consent, have cognitive impairment or present with periodontitis as a manifestation of systemic disease or syndrome are excluded. To ensure informed participation, only patients able to understand written and spoken Swedish are included.
Following confirmation of eligibility, patients are provided with oral and written information about the study and written informed consent is obtained. Capillary blood sampling is performed using a finger-prick method with a single-use lancet, and HbA1c is analyzed chair-side using a validated point-of-care device. The test does not require fasting or other patient preparation and is conducted in direct conjunction with the periodontal examination. The biological sample is not stored; only the test result is recorded in the patient's dental record.
Participants receive individualized feedback regarding their HbA1c result. For patients without a known diagnosis of diabetes who present with HbA1c values above the predefined threshold indicating hyperglycemia, information is provided regarding the potential risk of diabetes or prediabetes, and the patient is advised to contact primary care for further medical evaluation. Patients with known diabetes who exhibit HbA1c values indicating suboptimal glycemic control are encouraged to consult their diabetes care provider. In all cases, it is clearly communicated that the dental assessment does not constitute a medical diagnosis but serves as an indication warranting further evaluation.
In addition to HbA1c, clinical data are collected, including age, sex, smoking status, number of remaining teeth, bleeding on probing, number of periodontal pockets ≥6 mm, furcation involvement, and periodontal classification. These variables enables interpretation of glycemic findings in relation to periodontal disease severity. All data are recorded in a pseudonymized format for statistical analysis.
To capture the experience of the routine, patients are asked to complete a brief questionnaire assessing perceived meaningfulness associated with the blood sampling procedure. Dental staff involved in the procedure similarly assess perceived meaningfulness and time requirements. These qualitative measures provide insight into the practicality of implementing glycemic screening as a routine of specialist periodontal care.
The primary outcome measure is HbA1c expressed in mmol/mol, analyzed as a continuous variable and categorized according to established clinical thresholds. Secondary outcomes include the prevalence of previously undetected hyperglycemia among patients without known diabetes and the prevalence of inadequate glycemic control among patients with known diabetes. Descriptive statistical analyses are used to summarize HbA1c distributions and prevalence estimates in relation to periodontal characteristics. All analyses are conducted on pseudonymized datasets, and results are reported in aggregate form.
From an ethical perspective, the study is considered low risk. The capillary blood sampling procedure is minimally invasive and widely used in routine healthcare. Potential psychological discomfort related to identification of elevated HbA1c values is acknowledged; however, this risk is weighed against the benefit of early detection of hyperglycemia and the prevention of long-term diabetes-related complications. Selective screening restricted to patients with objectively verified advanced periodontitis is intended to reduce the risk of unnecessary referrals.
Personal data are handled in accordance with data protection regulations and guidelines. Identifiable data are stored securely within authorized clinical systems, while research datasets used for analysis are pseudonymized. No biological material is stored after analysis. Responsibility for data processing lies with the healthcare provider, and all research documentation is archived in accordance with institutional record-keeping requirements.
By integrating glycemic assessment into specialist periodontal evaluation, this study explores a model for interdisciplinary prevention that aligns oral health care with broader public health objectives. The findings are expected to inform future clinical routines and contribute to the development of evidence-based protocols for selective metabolic screening within dental specialist settings.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients referred for evaluation and treatment of periodontitis at the specialist clinic Folktandvarden Eastmaninstitutet who, following a full periodontal examination and radiographic assessment, are classified as having Stage III or Stage IV periodontitis according to current international criteria.
Key inclusion criteria (2 listed)
- adult patients >18 years
- classified as having Stage III or Stage IV periodontitis (according to current international criteria)
Key exclusion criteria (2 listed)
- Patients who are unable to provide informed consent because of significant cognitive impairment or unable to understand written and spoken Swedish
- Patients with periodontitis as a manifestation of systemic disease or syndrome
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 |
|---|---|---|
| Selective screening of blood glucose/HbA1cSelective screening for hyperglycaemia in dental setting is a new routine that has not been introduced in Folktandvården Stockholm. | Other | – |
Primary outcome
HbA1c mmol/mol
Time frame: The bloodsampling is done chair-side and is analysed immediatley with a Point-of-Care device meaning the procedure is limited to maximum 5 minutes.
The primary outcome measure is HbA1c expressed in mmol/mol, analyzed as a continuous variable and categorized according to established clinical thresholds. Descriptive statistical analyses are used to summarize HbA1c distributions and prevalence estimates in relation to periodontal characteristics.
1 secondary outcome
Hyperglycaemia
Time frame: As previously described, for the patients the capillary bloodsample is collected and analyzed in maximum 5 minutes
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 11 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis Stage III and Periodontitis Stage IV, run by Folktandvården Stockholms län AB at 1 site in 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 2 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 11 May 2026. 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 Sweden. 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?
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?
HbA1c mmol/mol (time frame: The bloodsampling is done chair-side and is analysed immediatley with a Point-of-Care device meaning the procedure is limited to maximum 5 minutes.). 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 11 May 2026.