Clinical trial

Salivary Function and Dental Changes During GLP-1 Therapy

Opening soon · Not applicable · 1 countries · Registry ID NCT07720466

Opening soonNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObesity, Dental Erosion, Saliva Collection, Saliva Altered

Full registry criteria

Inclusion Criteria: * 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. * Willingness to participate and ability to provide written informed consent. * Willingness to attend both the baseline and 3-month follow-up visits. Exclusion Criteria: * 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. * Pregnancy or breastfeeding. * Use of medications known to markedly affect salivary secretion. * Active orthodontic treatment. * Severe dental erosion requiring restorative treatment at baseline. * Edentulism or the absence of anterior teeth required for dental hard tissue assessment. * Inability or unwillingness to comply with the study protocol or attend the 3-month follow-up visit. * History of eating disorders associated with recurrent self-induced vomiting (e.g., bulimia nervosa). * Medical conditions causing persistent vomiting or severe gastroesophageal disease unrelated to GLP-1 therapy.

Treatments and study arms

Unstimulated Whole Saliva Collection

Procedure

Unstimulated 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

Saliva 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

Standardized 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

Standardized 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.

Primary outcomes

Change in salivary calcium concentrationBaseline and 3 months

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Department of Periodontology, Bilecik Seyh Edebali University Faculty of Dentistry🌐 Bilecik, Merkez, Turkey (Türkiye)

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Yasemin B. ÖNDER, DDS,pHDContact

Email · Call 05532502064