Salivary Function and Dental Changes During GLP-1 Therapy | NCT07720466

NCT07720466

Overview

NCT ID: NCT07720466
Lead Sponsor: Bilecik Seyh Edebali UniversitesiOTHER
Official Title: Prospective Evaluation of Salivary Calcium Levels, Salivary Function, and Dental Hard Tissue Changes in Patients Receiving GLP-1 Receptor Agonist Therapy
Brief 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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 22, 2026Actual
Start Date: Aug 17, 2026Estimated
Primary Completion Date: Oct 21, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility 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.

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 40Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: Yasemin B. ÖNDER, DDS, PhDContact
ybyilmaz@gmail.com+905532502064

Similar Studies

Participant Group/Arms

Semaglutide Group

Adults with obesity who are prescribed semaglutide by an endocrinologist according to routine clinical indications. Participants will undergo baseline oral examination, standardized intraoral photography, body weight assessment, and unstimulated whole saliva collection before initiating treatment. The same evaluations will be repeated after 3 months of therapy. Saliva samples will be analyzed for calcium concentration, pH, and salivary flow rate, and dental hard tissue changes will be assessed using the Basic Erosive Wear Examination (BEWE) index.Changes in salivary calcium concentration, salivary pH, salivary flow rate, BEWE scores, body weight, and standardized intraoral photographs will be compared between baseline and the 3-month follow-up, as well as between the two treatment groups.

Procedure: Unstimulated Whole Saliva Collection

Procedure: Salivary Analysis

Procedure: Oral Examination and BEWE Assessment

Procedure: Standardized Intraoral Photography

Tirzepatide Group

Adults with obesity who are prescribed tirzepatide by an endocrinologist according to routine clinical indications. Participants will undergo baseline oral examination, standardized intraoral photography, body weight assessment, and unstimulated whole saliva collection before initiating treatment. The same evaluations will be repeated after 3 months of therapy. Saliva samples will be analyzed for calcium concentration, pH, and salivary flow rate, and dental hard tissue changes will be assessed using the Basic Erosive Wear Examination (BEWE) index.Changes in salivary calcium concentration, salivary pH, salivary flow rate, BEWE scores, body weight, and standardized intraoral photographs will be compared between baseline and the 3-month follow-up, as well as between the two treatment groups.

Procedure: Unstimulated Whole Saliva Collection