Effects of GLP-1 Receptor Agonists on Saliva and Oral Health
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorKırıkkale University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
GLP-1 Receptor Agonists
DrugPatients 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: GLP-1 RA Group1 intervention
Trial outcomes
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).
Time frame
Baseline (Month 0), Month 3, and Month 6Secondary outcomes
1
Change in Stimulated Salivary Flow Rate
Stimulated saliva will be collected using the paraffin wax chewing method provided in the GC Saliva-Check Buffer kit (GC Corporation). Participants will chew the paraffin piece for 5 minutes, saliva will be collected into a graduated tube, and the flow rate will be calculated in milliliters per minute (mL/min).
Time frame
Baseline (Month 0), Month 3, and Month 62
Change in Salivary pH
Resting saliva pH will be determined using the GC Saliva-Check Buffer test kit (GC Corporation). A pH test strip will be immersed in the collected unstimulated saliva sample for 10 seconds and compared against the manufacturer's standardized color chart (ranges: 5.0 to 5.8 \[highly acidic\], 6.0 to 6.6 \[moderately acidic\], and 6.8 to 7.8 \[healthy/neutral\]). Higher pH values indicate a more neutral/healthy oral environment.
Time frame
Baseline (Month 0), Month 3, and Month 63
Change in Salivary Buffering Capacity
Evaluated using the GC Saliva-Check Buffer test kit (GC Corporation). One drop of stimulated saliva will be dispensed onto each of the three test pads on the strip. After 2 minutes, the color change on each pad will be scored from 0 to 4 (Green=4, Green/Blue=3, Blue=2, Red/Blue=1, Red=0). Scores are summed to give a total buffering capacity score ranging from 0 to 12 (0-5: very low; 6-9: low; 10-12: normal/high). Higher scores indicate better buffering capacity.
Time frame
Baseline (Month 0), Month 3, and Month 64
Change in Dental Plaque Accumulation
Assessed using the Silness and Löe Plaque Index (PI) on designated index teeth across buccal, lingual, mesial, and distal surfaces. Plaque presence is scored from 0 to 3 (0 = No plaque; 1 = A film of plaque adhering to the free gingival margin; 2 = Moderate accumulation of soft deposits; 3 = Abundance of soft matter within the gingival pocket and/or on the tooth margin). The individual mean score ranges from 0 to 3, where higher scores represent greater plaque accumulation and poorer oral hygiene.
Time frame
Baseline (Month 0), Month 3, and Month 6Sponsors and contacts
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Source ClinicalTrials.gov
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