PeriodontitisNCT07182123
GLP1-RA and Periodontitis
An observational study of Periodontitis and Diabetes (DM), run by Medical University of Graz.
Trial summary
Periodontitis is among the most common chronic diseases worldwide and, along with caries, represents the leading cause of tooth loss. More recent theories regarding the etiology of periodontitis also attribute a significant role to the body's inflammatory response in the development and progression of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Diabetes (DM)
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 24 Oct 2025to Jun 2026
- 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: Study participants will be recruited during routine care at the Clinical Division of Endocrinology and Diabetology, University Hospital Graz, where treatment is provided in accordance with current clinical guidelines. In line with the S2k guideline "Interrelationships between Periodontal Diseases and Diabetes Mellitus", patients receive standardized education on the bidirectional association between periodontitis and diabetes, as this relationship is regarded as clinically relevant. As part of recommended care, an annual periodontal examination is scheduled; accordingly, patients are referred from endocrinological diagnostics to the Clinical Division of Conservative Dentistry, Periodontology, and Prosthodontics for baseline periodontal assessment (Sanz, Ceriello et al. 2018).
Who may be able to join
- Written informed consent for participation and data protection
- Diagnosis of type 2 diabetes
- Diagnosis of chronic periodontitis (Caton, Armitage et al. 2018), presence of a PSI ≥ 3 in at least one sextant (Ainamo, Barmes et al. 1982)
Who cannot join
- Use of systemic antibiotics within the past 6 months
- Systematic periodontal treatment within the past 24 months
- Consumption of ≥ 5 cigarettes/day
- Unstable cardiovascular disease
- Chronic systemic diseases (e.g., rheumatoid arthritis, Crohn's disease, etc.)
- Pregnancy
- Use of the following medications: Immunosuppressants, Anticonvulsants, Calcium channel blockers
- Drug or medication abuse
About this study
Official title: The Influence of GLP1-RA on Periodontal Health - a Pilot Study
Periodontitis is among the most common chronic diseases worldwide and, along with caries, represents the leading cause of tooth loss. More recent theories regarding the etiology of periodontitis also attribute a significant role to the body's inflammatory response in the development and progression of the disease.
It is already well established that periodontitis is bidirectionally associated with other systemic inflammatory conditions, such as type 2 diabetes mellitus. Results from meta-analyses suggest that diabetes increases the likelihood of periodontal disease by approximately 24%, while periodontitis, conversely, raises the risk of type 2 diabetes by about 26%.
Read more
In addition to primary preventive measures and the modification of modifiable risk factors, diabetes mellitus is also treated pharmacologically with GLP-1 receptor agonists (GLP-1RA). In this context, Zhang et al. demonstrated that the administration of GLP-1RA, both in vitro and in vivo in rat models, leads to a significant reduction of pro-inflammatory substances in blood and periodontal tissue. However, to date, no clinical studies have investigated the effect of GLP-1RA on periodontal disease in humans.
For this reason, the aim of this pilot study is to investigate the effect of GLP-1RA on the periodontal status of patients with periodontitis. The data from this pilot study will subsequently be used to perform a power analysis to determine the sample size for a double-blind, placebo-controlled clinical trial.
- Conditions
- Periodontitis, Diabetes (DM)
- Keywords
- periodontitis, diabetes, GLP1-RA
- Medical subject headings
- Periodontitis, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of weekly GLP1-RA administration on periodontal clinical parameters (PD, CAL, BOP, furcation involvement, and tooth mobility) measured using a periodontal probe in patients with stage III or IV periodontitis.
Measured: From enrollment to the end of treatment at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start24 Oct 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182123
- Sponsor's protocol ID
- 1378/2025
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of GLP1-RA on Periodontal Health - a Pilot Study
- ClinicalTrials.gov ID
- NCT07182123
- Acronym / sponsor ID
- 1378/2025
- Conditions
- Periodontitis, Diabetes (DM)
- Keywords
- periodontitis, diabetes, GLP1-RA
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 24 Oct 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 19 Sep 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.
Periodontitis is among the most common chronic diseases worldwide and, along with caries, represents the leading cause of tooth loss. More recent theories regarding the etiology of periodontitis also attribute a significant role to the body's inflammatory response in the development and progression of the disease.
It is already well established that periodontitis is bidirectionally associated with other systemic inflammatory conditions, such as type 2 diabetes mellitus. Results from meta-analyses suggest that diabetes increases the likelihood of periodontal disease by approximately 24%, while periodontitis, conversely, raises the risk of type 2 diabetes by about 26%.
In addition to primary preventive measures and the modification of modifiable risk factors, diabetes mellitus is also treated pharmacologically with GLP-1 receptor agonists (GLP-1RA). In this context, Zhang et al. demonstrated that the administration of GLP-1RA, both in vitro and in vivo in rat models, leads to a significant reduction of pro-inflammatory substances in blood and periodontal tissue. However, to date, no clinical studies have investigated the effect of GLP-1RA on periodontal disease in humans.
For this reason, the aim of this pilot study is to investigate the effect of GLP-1RA on the periodontal status of patients with periodontitis. The data from this pilot study will subsequently be used to perform a power analysis to determine the sample size for a double-blind, placebo-controlled clinical trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be recruited during routine care at the Clinical Division of Endocrinology and Diabetology, University Hospital Graz, where treatment is provided in accordance with current clinical guidelines. In line with the S2k guideline "Interrelationships between Periodontal Diseases and Diabetes Mellitus", patients receive standardized education on the bidirectional association between periodontitis and diabetes, as this relationship is regarded as clinically relevant. As part of recommended care, an annual periodontal examination is scheduled; accordingly, patients are referred from endocrinological diagnostics to the Clinical Division of Conservative Dentistry, Periodontology, and Prosthodontics for baseline periodontal assessment (Sanz, Ceriello et al. 2018).
Key inclusion criteria (3 listed)
- Written informed consent for participation and data protection
- Diagnosis of type 2 diabetes
- Diagnosis of chronic periodontitis (Caton, Armitage et al. 2018), presence of a PSI ≥ 3 in at least one sextant (Ainamo, Barmes et al. 1982)
Key exclusion criteria (8 listed)
- Use of systemic antibiotics within the past 6 months
- Systematic periodontal treatment within the past 24 months
- Consumption of ≥ 5 cigarettes/day
- Unstable cardiovascular disease
- Chronic systemic diseases (e.g., rheumatoid arthritis, Crohn's disease, etc.)
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
Effect of weekly GLP1-RA administration on periodontal clinical parameters (PD, CAL, BOP, furcation involvement, and tooth mobility) measured using a periodontal probe in patients with stage III or IV periodontitis.
Time frame: From enrollment to the end of treatment at 16 weeks
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 24 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis and Diabetes (DM), run by Medical University of Graz.
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 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: opening soon, as of the sponsor's last update on 24 Sep 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?
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?
Effect of weekly GLP1-RA administration on periodontal clinical parameters (PD, CAL, BOP, furcation involvement, and tooth mobility) measured using a periodontal probe in patients with stage III or IV periodontitis. (time frame: From enrollment to the end of treatment at 16 weeks). 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 Sep 2025; AzTrials last refreshed its copy on 31 Oct 2026.