MODERN-Dental: Pediatric Obesity, Cardiometabolic Risks, And Periodontal Disease: Effects Of Semaglutide Treatment
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 gingival index
研究概览
简要总结
The goal of this clinical trial is to assess whether adjunctive dental cleaning can enhance the effects of semaglutide in children with obesity. The main question[s] it aims to answer [is/are]:
if dental cleaning will improve both oral health and metabolic outcomes beyond the effects of semaglutide alone.
Participants will receive either dental cleaning and oral hygiene instruction or oral hygiene instruction alone.
详细描述
Parent study NCT06967389
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participants from the ongoing Mitigation of Cardiovascular Disease Risks in Children with Extreme Obesity (MODERN) study (NCT06967389)
- •Class 2 or 3 obesity (BMI =120% of the 95th percentile for age and sex)
排除标准
- •Same exclusion as parent study.
- •Planning to receive or complete dental services during the 12-month course of the study
- •Ongoing orthodontic treatment
- •Use of any anti-inflammatory medication (other than steroids) within 1 month prior to enrollment
- •Currently taking medications that could influence the characteristics or response to periodontal treatment (e.g., use of immunosuppressants or steroids)
- •Local or systemic antibiotic use within 15 days prior to enrollment or for >10 days within the past 3 months
- •History of bleeding disorders
- •Professional dental prophylaxis or non-surgical periodontal therapy within the past 6 months
研究组 & 干预措施
Oral Hygiene Instruction (OHI) only
干预措施: Oral Hygiene Instruction (OHI) (Behavioral)
Dental cleaning and Oral Hygiene Instruction (OHI)
干预措施: Dental Cleaning and Oral Hygiene Instruction (OHI) (Procedure)
结局指标
主要结局
Change in gingival index
时间窗: Baseline, 6 months, 12 months
Based on visual assessment and gentle probing of the marginal periodontal tissues. Scored on a 0-3 scale and the higher score means increased inflammation.
Change in probing depth
时间窗: Baseline, 6 months, 12 months
Measuring the pocket depth at six sites per tooth (in millimeters) using a UNC-15 periodontal probe.
Change in BOP (Bleeding on probing)
时间窗: Baseline, 6 months, 12 months
Presence or absence of bleeding upon probing recorded at six sites per tooth.
Change in Plaque Index
时间窗: Baseline, 6 months, 12 months
Measured using a plaque score (0-3) at six specific Ramfjord teeth
Change in Clinical Attachment Level (CAL)
时间窗: Baseline, 6 months, 12 months
Calculated as PD (Pocket Depth) + GM (Gingival Margin) for each site.
Change in Gingival Margin Position (GM)
时间窗: Baseline, 6 months, 12 months
Recorded at six sites per tooth (in millimeters) using a UNC-15 periodontal probe.
Change in Gingival Crevicular Fluid (GCF)
时间窗: Baseline, 6 months, 12 months
Up to six samples per participant using Periopaper strips at mesiobuccal interproximal sites.
Change in Bacterial Subgingival Biofilm
时间窗: Baseline, 6 months, 12 months
Collected from the same sites as GCF using sterile endodontic paper points.
Change in Oral Microbiome
时间窗: Baseline, 6 months, 12 months
DNA sequencing. Saliva will be collected.
Change in active oral microbiome (RNA sequencing)
时间窗: Baseline, 6 months, 12 months
RNA sequencing. Saliva will be collected.
Number of participants with Supragingival and Subgingival Calculus
时间窗: Baseline, 6 months, 12 months
Recorded as present or absent, generalized or localized when visible or detected upon probing.
Change in levels of Interleukin-1 beta (IL-1β)
时间窗: Baseline, 6 months, 12 months
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Change in levels of Tumor Necrosis Factor-alpha
时间窗: Baseline, 6 months, 12 months
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Change in levels of Interleukin-6 (IL-6)
时间窗: Baseline, 6 months, 12 months
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Change in levels of C-reactive protein (CRP)
时间窗: Baseline, 6 months, 12 months
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Change in levels of Soluble intercellular adhesion molecule-1 (sICAM-1)
时间窗: Baseline, 6 months, 12 months
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Change in levels of Soluble vascular cell adhesion molecule-1 (sVCAM-1)
时间窗: Baseline, 6 months, 12 months
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Change in levels of endocan
时间窗: Baseline, 6 months, 12 months
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Change in levels of Vascular Endothelial Growth Factor A (VEGF-A)
时间窗: Baseline, 6 months, 12 months
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
次要结局
未报告次要终点
研究者
Oelisoa Andriankaja
Associate Professor
University of Kentucky