Prospective Evaluation of the Effects of GLP-1 Receptor Agonists on Salivary Physicochemical Parameters, Antimicrobial Peptide Levels, and Oral Health
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Unstimulated Salivary Flow Rate
研究概览
简要总结
This study aims to evaluate the effects of GLP-1 receptor agonists (GLP-1RA) on salivary parameters and oral health in individuals who will use this medication for the first time due to a diagnosis of Type 2 diabetes and/or obesity. The research will be conducted with a longitudinal design including a total of 50 participants. Clinical examinations and saliva analyses will be performed at baseline (month 0), month 3, and month 6. The study will evaluate stimulated and unstimulated salivary flow rates, pH, and buffering capacity, as well as analyze antimicrobial peptide levels (sIgA and beta-defensin-3) and total protein. Participants' oral hygiene and caries activity will be measured using the Silness and Löe Plaque Index (PI), DMFT, and ICDAS-II indices. Additionally, dietary habits and subjective dry mouth symptoms will be monitored through questionnaires. The obtained data will be statistically analyzed by controlling for potential confounding factors such as HbA1c, BMI, CRP, and HOMA index.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Type 2 Diabetes Mellitus and/or Obesity.
- •Newly prescribed a GLP-1 receptor agonist and naive to GLP-1 receptor agonist therapy.
- •Aged 18 to 65 years
- •Willing to provide saliva samples and complete study questionnaires.
排除标准
- •Presence of Sjögren's syndrome or known salivary gland disease.
- •History of radiation therapy to the head and neck region.
- •Use of antibiotic or antifungal medications within the last 3 months.
- •Pregnancy, lactation, or active orthodontic treatment.
- •Presence of other severe systemic diseases or use of medications that affect salivary flow.
研究组 & 干预措施
GLP-1 RA Group
Patients diagnosed with Type 2 diabetes and/or obesity who are newly prescribed GLP-1 receptor agonists.
干预措施: GLP-1 Receptor Agonists (Drug)
结局指标
主要结局
Change in Unstimulated Salivary Flow Rate
时间窗: Baseline (Month 0), Month 3, and Month 6
According to the GC Saliva-Check Buffer kit (GC Corporation) instructions, following a visual inspection, unstimulated whole saliva will be collected via the passive drooling/spitting method for 5 minutes with the participant seated upright and head tilted slightly forward. The resting salivary flow rate will be calculated and reported in milliliters per minute (mL/min).
次要结局
- Change in Stimulated Salivary Flow Rate(Baseline (Month 0), Month 3, and Month 6)
- Change in Salivary pH(Baseline (Month 0), Month 3, and Month 6)
- Change in Salivary Buffering Capacity(Baseline (Month 0), Month 3, and Month 6)
- Change in Dental Plaque Accumulation(Baseline (Month 0), Month 3, and Month 6)
- Change in Dental Caries Status(Baseline (Month 0), Month 3, and Month 6)
- Change in Subjective Dry Mouth Symptoms(Baseline (Month 0), Month 3, and Month 6)
- Change in Dietary and Nutritional Habits(Baseline (Month 0), Month 3, and Month 6)
- Change in Salivary Secretory Immunoglobulin A (sIgA) Levels(Baseline (Month 0), Month 3, and Month 6)
- Change in Salivary Beta-Defensin-3 Levels(Baseline (Month 0), Month 3, and Month 6)
- Change in Salivary Total Protein Concentration(Baseline (Month 0), Month 3, and Month 6)
- Change in Serum C-Reactive Protein Levels(Baseline (Month 0), Month 3, and Month 6)
- Change in Homeostatic Model Assessment for Insulin Resistance(Baseline (Month 0), Month 3, and Month 6)
- Change in Glycated Hemoglobin (HbA1c) Levels(Baseline (Month 0), Month 3, and Month 6)
- Change in Body Mass Index(Baseline (Month 0), Month 3, and Month 6)
研究者
Merve Haberal
Assistant Professor of Restorative Dentistry
Kırıkkale University