Effects of GLP-1 Receptor Agonists on Saliva and Oral Health
Prospective Evaluation of the Effects of GLP-1 Receptor Agonists on Salivary Physicochemical Parameters, Antimicrobial Peptide Levels, and Oral Health
2 other identifiers
observational
50
1 country
1
Brief Summary
This study aims to evaluate the effects of GLP-1 receptor agonists (GLP-1RA) on salivary parameters and oral health in individuals who will use this medication for the first time due to a diagnosis of Type 2 diabetes and/or obesity. The research will be conducted with a longitudinal design including a total of 50 participants. Clinical examinations and saliva analyses will be performed at baseline (month 0), month 3, and month 6. The study will evaluate stimulated and unstimulated salivary flow rates, pH, and buffering capacity, as well as analyze antimicrobial peptide levels (sIgA and beta-defensin-3) and total protein. Participants' oral hygiene and caries activity will be measured using the Silness and Löe Plaque Index (PI), DMFT, and ICDAS-II indices. Additionally, dietary habits and subjective dry mouth symptoms will be monitored through questionnaires. The obtained data will be statistically analyzed by controlling for potential confounding factors such as HbA1c, BMI, CRP, and HOMA index.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2026
CompletedFirst Posted
Study publicly available on registry
September 14, 2026
CompletedStudy Start
First participant enrolled
October 16, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
July 16, 2027
Study Completion
Last participant's last visit for all outcomes
December 15, 2027
September 14, 2026
September 1, 2026
9 months
September 2, 2026
September 8, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Unstimulated Salivary Flow Rate
According to the GC Saliva-Check Buffer kit (GC Corporation) instructions, following a visual inspection, unstimulated whole saliva will be collected via the passive drooling/spitting method for 5 minutes with the participant seated upright and head tilted slightly forward. The resting salivary flow rate will be calculated and reported in milliliters per minute (mL/min).
Baseline (Month 0), Month 3, and Month 6
Secondary Outcomes (14)
Change in Stimulated Salivary Flow Rate
Baseline (Month 0), Month 3, and Month 6
Change in Salivary pH
Baseline (Month 0), Month 3, and Month 6
Change in Salivary Buffering Capacity
Baseline (Month 0), Month 3, and Month 6
Change in Dental Plaque Accumulation
Baseline (Month 0), Month 3, and Month 6
Change in Dental Caries Status
Baseline (Month 0), Month 3, and Month 6
- +9 more secondary outcomes
Study Arms (1)
GLP-1 RA Group
Patients diagnosed with Type 2 diabetes and/or obesity who are newly prescribed GLP-1 receptor agonists.
Interventions
Patients diagnosed with Type 2 diabetes and/or obesity who are newly prescribed GLP-1 receptor agonists as part of their routine medical treatment. Baseline assessments are performed prior to the first dose, and no drug administration or dosage modification is performed by the researcher.
Eligibility Criteria
Patients admitted to the clinic who are diagnosed with Type 2 diabetes and/or obesity and are newly scheduled to initiate treatment with GLP-1 receptor agonists.
You may qualify if:
- Diagnosed with Type 2 Diabetes Mellitus and/or Obesity.
- Newly prescribed a GLP-1 receptor agonist and naive to GLP-1 receptor agonist therapy.
- Aged 18 to 65 years
- Willing to provide saliva samples and complete study questionnaires.
You may not qualify if:
- Presence of Sjögren's syndrome or known salivary gland disease.
- History of radiation therapy to the head and neck region.
- Use of antibiotic or antifungal medications within the last 3 months.
- Pregnancy, lactation, or active orthodontic treatment.
- Presence of other severe systemic diseases or use of medications that affect salivary flow.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kirikkale University Faculty of Dentistry
Kirikkale, Yahsihan, 71450, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Restorative Dentistry
Study Record Dates
First Submitted
September 2, 2026
First Posted
September 14, 2026
Study Start (Estimated)
October 16, 2026
Primary Completion (Estimated)
July 16, 2027
Study Completion (Estimated)
December 15, 2027
Last Updated
September 14, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share
Individual participant data (IPD) will not be shared with third parties or other researchers to protect patient privacy and confidentiality, in strict accordance with the commitments made in the Informed Consent Form approved by the Institutional Ethics Committee.