Salivary Function and Dental Changes During GLP-1 Therapy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBilecik Seyh Edebali Universitesi
About this trial
People who use glucagon-like peptide-1 (GLP-1) receptor agonists, such as semaglutide and tirzepatide, may experience changes in their oral health. Some people report dry mouth, changes in saliva, and increased wear of their teeth after starting these medicines. However, little is known about whether these medicines affect saliva and dental hard tissues.
The purpose of this study is to evaluate changes in salivary calcium levels, salivary function, and dental hard tissues in adults who begin treatment with semaglutide or tirzepatide for obesity.
Approximately 40 participants will be enrolled before starting GLP-1 receptor agonist therapy. Oral examinations, standardized intraoral photographs, saliva samples, and body weight measurements will be obtained before treatment and again after three months. Saliva samples will be analyzed for calcium concentration, pH, and salivary flow rate. Dental hard tissue changes will be assessed using the Basic Erosive Wear Examination (BEWE) index.
The findings from this study may improve understanding of the effects of GLP-1 receptor agonists on oral health and help healthcare professionals identify and prevent possible dental complications during treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older.
Body mass index (BMI) ≥27 kg/m².
Clinical decision by an endocrinologist to initiate semaglutide or tirzepatide therapy for obesity management.
No previous treatment with GLP-1 receptor agonists.
Disqualifiers
Previous use of any GLP-1 receptor agonist.
History of head and neck radiotherapy.
Sjögren syndrome or other systemic diseases affecting salivary gland function.
Chronic kidney disease.
Trial population
The study population will consist of adults (≥18 years) with obesity (BMI ≥27 kg/m²) who are prescribed semaglutide or tirzepatide for obesity management according to routine clinical practice. Participants will be recruited before initiating GLP-1 receptor agonist therapy at the Endocrinology and Metabolism outpatient clinic and will undergo standardized oral examinations and saliva assessments at baseline and after 3 months of treatment.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Unstimulated Whole Saliva Collection
Procedure/SurgeryUnstimulated whole saliva will be collected for 10 minutes at baseline and after 3 months. Participants will refrain from eating, drinking, smoking, chewing gum, and performing oral hygiene procedures for at least 2 hours before sample collection. Salivary flow rate will be calculated, and saliva samples will be processed for pH measurement and calcium analysis.
Salivary Analysis
Procedure/SurgerySaliva samples will be centrifuged at 3,000 × g for 10 minutes at 4°C. Salivary pH will be measured, and the supernatant will be stored at -80°C until calcium concentration analysis.
Oral Examination and BEWE Assessment
Procedure/SurgeryStandardized oral examinations will be performed at baseline and after 3 months. Dental hard tissue status will be evaluated using the Basic Erosive Wear Examination (BEWE) index by calibrated examiners.
Standardized Intraoral Photography
Procedure/SurgeryStandardized intraoral photographs will be obtained at baseline and after 3 months using a predefined photographic protocol. Images will be coded and evaluated for dental hard tissue changes by blinded assessors.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Semaglutide Group4 interventions
Group B: Tirzepatide Group4 interventions
Trial outcomes
Primary outcomes
1
Change in salivary calcium concentration
Change in salivary calcium concentration (mg/dL) measured in unstimulated whole saliva using a colorimetric biochemical assay between baseline and 3 months after initiation of semaglutide or tirzepatide therapy.
Time frame
Baseline and 3 monthsSecondary outcomes
1
Change in salivary pH
Change in unstimulated salivary pH measured using a digital pH meter between baseline and 3 months.
Time frame
Baseline and 3 months2
Change in unstimulated salivary flow rate
Change in unstimulated salivary flow rate (mL/min) calculated from saliva collected over a standardized 10-minute period between baseline and 3 months.
Time frame
Baseline and 3 months3
Change in dental hard tissue status
Change in dental erosive wear assessed using the Basic Erosive Wear Examination (BEWE) scoring system (score 0-18) between baseline and 3 months.
Time frame
Baseline and 3 months4
Change in body mass index
Change in body mass index (kg/m²) calculated from measured body weight and height between baseline and 3 months.
Time frame
Baseline and 3 monthsSponsors and contacts
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Source ClinicalTrials.gov
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