ObesityNCT07720466
Salivary Function and Dental Changes During GLP-1 Therapy
An observational study of Obesity and Dental Erosion, run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Dental Erosion, Saliva Collection
- What is being tested?
- Unstimulated Whole Saliva Collection, Salivary Analysis and Oral Examination and BEWE Assessment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Aug 2026to 17 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Department of Periodontology, Bilecik Seyh Edebali University Faculty of Dentistry
Bilecik, Merkez, 11100
Yasemin B. ÖNDER, DDS,pHD, 05532502064, ybyilmaz@gmail.com
About this study
Official title: Prospective Evaluation of Salivary Calcium Levels, Salivary Function, and Dental Hard Tissue Changes in Patients Receiving GLP-1 Receptor Agonist Therapy
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.
Read more
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.
Read the detailed description
Glucagon-like peptide-1 (GLP-1) receptor agonists, including semaglutide and tirzepatide, have become widely used for the treatment of obesity because of their substantial effects on body weight reduction and metabolic control. As the use of these medications continues to increase, attention has shifted toward their potential systemic and oral adverse effects. Recent clinical reports and pharmacovigilance studies have described oral complaints such as xerostomia, hyposalivation, oral discomfort, altered taste perception, and dental problems in individuals receiving GLP-1 receptor agonist therapy. However, the biological mechanisms underlying these observations remain largely unknown.
Saliva is essential for maintaining oral homeostasis. It provides lubrication, buffering capacity, antimicrobial protection, and contributes to the remineralization of dental hard tissues through its mineral content, particularly calcium and phosphate ions. Alterations in salivary secretion, pH, or mineral composition may impair the protective functions of saliva, thereby increasing the susceptibility to dental erosion, enamel demineralization, and other hard tissue alterations. Although reduced salivary flow has been described in isolated reports of semaglutide users, prospective clinical evidence evaluating changes in salivary composition during GLP-1 receptor agonist therapy is currently lacking.
Weight loss associated with GLP-1 receptor agonists may also indirectly influence oral health. Gastrointestinal adverse effects, particularly nausea and vomiting, as well as changes in dietary habits, fluid intake, and gastroesophageal reflux symptoms, may increase exposure of dental tissues to acidic conditions. Furthermore, dehydration resulting from reduced oral intake or gastrointestinal symptoms may contribute to impaired salivary function. These factors may act individually or synergistically to influence the integrity of dental hard tissues during treatment.
This prospective observational cohort study aims to evaluate changes in salivary calcium concentration, salivary flow rate, salivary pH, and dental hard tissues in adults initiating semaglutide or tirzepatide therapy for obesity. Participants will undergo standardized oral examinations, body weight measurements, intraoral photography, and unstimulated whole saliva collection before treatment initiation and after three months of therapy. Dental hard tissue changes will be assessed using the Basic Erosive Wear Examination (BEWE) index, while saliva samples will be analyzed for calcium concentration, pH, and salivary flow rate using standardized laboratory procedures.
The primary objective of this study is to determine whether treatment with GLP-1 receptor agonists is associated with changes in salivary calcium concentration during the first three months of therapy. Secondary objectives include evaluating changes in salivary pH, salivary flow rate, dental hard tissue status assessed by BEWE, body weight, and standardized photographic findings. In addition, the study will investigate the relationships between weight loss, gastrointestinal symptoms, salivary alterations, and dental hard tissue changes.
Because prospective studies evaluating the oral effects of GLP-1 receptor agonists remain limited, this study is expected to provide novel clinical evidence regarding the potential impact of these medications on salivary function and dental hard tissues. The findings may contribute to the early recognition of oral changes during obesity pharmacotherapy and support the development of preventive strategies through collaboration between endocrinologists and dental professionals.
- Conditions
- Obesity, Dental Erosion, Saliva Collection, Saliva Altered
- Being tested
- Unstimulated Whole Saliva Collection, Salivary Analysis, Oral Examination and BEWE Assessment, Standardized Intraoral Photography
- Medical subject headings
- Obesity, Tooth Erosion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unstimulated Whole Saliva CollectionProcedure or surgery
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 AnalysisProcedure or surgery
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 AssessmentProcedure or surgery
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 PhotographyProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Unstimulated Whole Saliva Collection; Procedure: Salivary Analysis; Procedure: Oral Examination and BEWE Assessment; Procedure: Standardized Intraoral Photography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 3 months
Secondary outcomes (5)
Change in salivary pH
Change in unstimulated salivary pH measured using a digital pH meter between baseline and 3 months.
Measured: Baseline and 3 months
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.
Measured: Baseline and 3 months
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.
Measured: Baseline and 3 months
Change in body mass index
Change in body mass index (kg/m²) calculated from measured body weight and height between baseline and 3 months.
Measured: Baseline and 3 months
Change in body weight
Change in body weight (kg) measured using a calibrated digital scale between baseline and 3 months.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start17 Aug 2026 (estimated)
- Primary completion21 Oct 2026 (estimated)
- Study completion17 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bilecik Seyh Edebali Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720466
- Sponsor's protocol ID
- BSEU-ONDER-003
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the primary study results will be shared upon reasonable request. The dataset will include demographic characteristics, body weight, body mass index, treatment group, medication dose, salivary calcium concentration, salivary pH, salivary flow rate, BEWE scores, and other coded clinical variables. The study protocol, statistical analysis plan, and data dictionary will also be available. Original photographs and biological specimens will not be shared. Data access will require approval of a scientifically sound research proposal and a data-sharing agreement.
Publications
Kim YJ, Kim YB, Kim S, Choi TY, Park HK, Choi SY. Chlorpromazine induces hyposalivation by inhibiting muscarinic Ca2+ signaling in salivary glands. Naunyn Schmiedebergs Arch Pharmacol. 2026 Jan;399(1):941-951. doi: 10.1007/s00210-025-04438-8. Epub 2025 Jul 23.
PubMed 40699237Mawardi HH, Almazrooa SA, Dakhil SA, Aboalola AA, Al-Ghalib TA, Eshky RT, Niyazi AA, Mawardi MH. Semaglutide-associated hyposalivation: A report of case series. Medicine (Baltimore). 2023 Dec 29;102(52):e36730. doi: 10.1097/MD.0000000000036730.
PubMed 38206684Barac M, Roganovic J. GLP-1 Receptor Signaling and Oral Dysfunction: A Narrative Review on the Mechanistic Basis of Semaglutide-Related Oral Adverse Effects. Biology (Basel). 2025 Nov 23;14(12):1650. doi: 10.3390/biology14121650.
PubMed 41463424
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Salivary Calcium Levels, Salivary Function, and Dental Hard Tissue Changes in Patients Receiving GLP-1 Receptor Agonist Therapy
- ClinicalTrials.gov ID
- NCT07720466
- Acronym / sponsor ID
- BSEU-ONDER-003
- Conditions
- Obesity, Dental Erosion, Saliva Collection, Saliva Altered
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bilecik Seyh Edebali UniversitesiUniversity, hospital or other
- Study start
- 17 Aug 2026 (estimated)
- Primary completion
- 21 Oct 2026 (estimated)
- Study completion
- 17 Mar 2027 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Glucagon-like peptide-1 (GLP-1) receptor agonists, including semaglutide and tirzepatide, have become widely used for the treatment of obesity because of their substantial effects on body weight reduction and metabolic control. As the use of these medications continues to increase, attention has shifted toward their potential systemic and oral adverse effects. Recent clinical reports and pharmacovigilance studies have described oral complaints such as xerostomia, hyposalivation, oral discomfort, altered taste perception, and dental problems in individuals receiving GLP-1 receptor agonist therapy. However, the biological mechanisms underlying these observations remain largely unknown.
Saliva is essential for maintaining oral homeostasis. It provides lubrication, buffering capacity, antimicrobial protection, and contributes to the remineralization of dental hard tissues through its mineral content, particularly calcium and phosphate ions. Alterations in salivary secretion, pH, or mineral composition may impair the protective functions of saliva, thereby increasing the susceptibility to dental erosion, enamel demineralization, and other hard tissue alterations. Although reduced salivary flow has been described in isolated reports of semaglutide users, prospective clinical evidence evaluating changes in salivary composition during GLP-1 receptor agonist therapy is currently lacking.
Weight loss associated with GLP-1 receptor agonists may also indirectly influence oral health. Gastrointestinal adverse effects, particularly nausea and vomiting, as well as changes in dietary habits, fluid intake, and gastroesophageal reflux symptoms, may increase exposure of dental tissues to acidic conditions. Furthermore, dehydration resulting from reduced oral intake or gastrointestinal symptoms may contribute to impaired salivary function. These factors may act individually or synergistically to influence the integrity of dental hard tissues during treatment.
This prospective observational cohort study aims to evaluate changes in salivary calcium concentration, salivary flow rate, salivary pH, and dental hard tissues in adults initiating semaglutide or tirzepatide therapy for obesity. Participants will undergo standardized oral examinations, body weight measurements, intraoral photography, and unstimulated whole saliva collection before treatment initiation and after three months of therapy. Dental hard tissue changes will be assessed using the Basic Erosive Wear Examination (BEWE) index, while saliva samples will be analyzed for calcium concentration, pH, and salivary flow rate using standardized laboratory procedures.
The primary objective of this study is to determine whether treatment with GLP-1 receptor agonists is associated with changes in salivary calcium concentration during the first three months of therapy. Secondary objectives include evaluating changes in salivary pH, salivary flow rate, dental hard tissue status assessed by BEWE, body weight, and standardized photographic findings. In addition, the study will investigate the relationships between weight loss, gastrointestinal symptoms, salivary alterations, and dental hard tissue changes.
Because prospective studies evaluating the oral effects of GLP-1 receptor agonists remain limited, this study is expected to provide novel clinical evidence regarding the potential impact of these medications on salivary function and dental hard tissues. The findings may contribute to the early recognition of oral changes during obesity pharmacotherapy and support the development of preventive strategies through collaboration between endocrinologists and dental professionals.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide Group | – | Procedure: Unstimulated Whole Saliva Collection, Procedure: Salivary Analysis, Procedure: Oral Examination and BEWE Assessment, Procedure: Standardized Intraoral PhotographyAdults 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. |
| Tirzepatide Group | – | Procedure: Unstimulated Whole Saliva Collection, Procedure: Salivary Analysis, Procedure: Oral Examination and BEWE Assessment, Procedure: Standardized Intraoral PhotographyAdults 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unstimulated Whole Saliva CollectionUnstimulated 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. | Procedure or surgery | Semaglutide Group, Tirzepatide Group |
| Salivary AnalysisSaliva 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. | Procedure or surgery | Semaglutide Group, Tirzepatide Group |
| Oral Examination and BEWE AssessmentStandardized 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. | Procedure or surgery | Semaglutide Group, Tirzepatide Group |
| Standardized Intraoral PhotographyStandardized 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. | Procedure or surgery | Semaglutide Group, Tirzepatide Group |
Primary outcome
Change in salivary calcium concentration
Time frame: 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.
5 secondary outcomes
Change in salivary pH
Time frame: Baseline and 3 months
Change in unstimulated salivary flow rate
Time frame: Baseline and 3 months
Change in dental hard tissue status
Time frame: Baseline and 3 months
Change in body mass index
Time frame: Baseline and 3 months
Change in body weight
Time frame: Baseline and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Background: PubMed 40699237Kim YJ, Kim YB, Kim S, Choi TY, Park HK, Choi SY. Chlorpromazine induces hyposalivation by inhibiting muscarinic Ca2+ signaling in salivary glands. Naunyn Schmiedebergs Arch Pharmacol. 2026 Jan;399(1):941-951. doi: 10.1007/s00210-025-04438-8. Epub 2025 Jul 23.
- Background: PubMed 38206684Mawardi HH, Almazrooa SA, Dakhil SA, Aboalola AA, Al-Ghalib TA, Eshky RT, Niyazi AA, Mawardi MH. Semaglutide-associated hyposalivation: A report of case series. Medicine (Baltimore). 2023 Dec 29;102(52):e36730. doi: 10.1097/MD.0000000000036730.
- Background: PubMed 41463424Barac M, Roganovic J. GLP-1 Receptor Signaling and Oral Dysfunction: A Narrative Review on the Mechanistic Basis of Semaglutide-Related Oral Adverse Effects. Biology (Basel). 2025 Nov 23;14(12):1650. doi: 10.3390/biology14121650.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the primary study results will be shared upon reasonable request. The dataset will include demographic characteristics, body weight, body mass index, treatment group, medication dose, salivary calcium concentration, salivary pH, salivary flow rate, BEWE scores, and other coded clinical variables. The study protocol, statistical analysis plan, and data dictionary will also be available. Original photographs and biological specimens will not be shared. Data access will require approval of a scientifically sound research proposal and a data-sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Dental Erosion, run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yasemin B. ÖNDER, DDS, PhD (+905532502064, ybyilmaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in salivary calcium concentration (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07720466, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.