Salivary Function and Dental Changes During GLP-1 Therapy

Sponsor
Bilecik Seyh Edebali Universitesi
Study ID
NCT07720466
Status
Not Yet Recruiting

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Conditions

  • Dental Erosion
  • Obesity
  • Saliva Altered
  • Saliva Collection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Jul 22, 2026
Start date
Aug 17, 2026
Status verified
Jul 2026
Primary completion
Oct 21, 2026
Completion
Mar 17, 2027

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Change in salivary calcium concentration [ Time Frame: Baseline and 3 months ]

Central Contacts

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