NCT07818226

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

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
14mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 14, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 16, 2026

Expected
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2027

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2027

Last Updated

September 14, 2026

Status Verified

September 1, 2026

Enrollment Period

9 months

First QC Date

September 2, 2026

Last Update Submit

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.

Drug: 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.

GLP-1 RA Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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.

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)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2ObesityOverweightXerostomiaDental Caries

Interventions

Glucagon-Like Peptide-1 Receptor Agonists

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesTooth DemineralizationTooth Diseases

Intervention Hierarchy (Ancestors)

Hypoglycemic AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Central Study Contacts

Merve Haberal, Assist. Prof. Dr.

CONTACT

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.

Locations