Salivary Function and Dental Changes During GLP-1 Therapy

Condition(s) studied

Investigational drug(s) / intervention(s)

Unstimulated Whole Saliva Collection: 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: 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: 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: 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.

Study summary

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

Primary outcome measure(s)

• Change in salivary calcium concentration — Baseline 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.

Trial sites (1)

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