Randomized Clinical Trial on the Effect of Vitamin D Supplement Prior to Non-surgical Periodontal Therapy: a Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Change in periodontitis status after treatment (2017 case definition)
研究概览
简要总结
The purpose of this study is to test the feasibility i. e. to examine all aspects necessary for the implementation of a future randomized clinical trial (RCT) that aims to determine whether non-surgical periodontal treatment can be improved by concomitant intake of vitamin D.
详细描述
Vitamin D is believed to have anti-inflammatory and anti-bacterial properties. This is hypnotized to play a role in periodontitis. Well-designed RCTs on this theme are lacking. We therefore aim at testing a proposed study design in a pilot study, on vitamin D supplementation and its possible adjunctive effect on non-surgical periodontitis treatment (NSPT).
Altogether 28 patients with a referral for treatment at the Public Dental Service Competence Center of Northern Norway (TkNN), diagnosed with periodontitis Stage I-IV, and within the ages of 20-60 years will be recruited. Participation is voluntary and based on written informed consent.
The participants will randomly be allocated into two groups of equal sizes. The intervention group will receive vitamin D supplementation of 30 µg/day, and the control group will receive placebo tablets. The study is double-blinded.
The participants will be instructed to take the tablets once a day for four weeks prior to the onset of the NSPT, and for two additional weeks after their first NSPT, altogether six weeks. The aim is to ensure that the vitamin D status among those who receive vitamin D supplementation is satisfactory at the start of NSPT and throughout the NSPT period.
At baseline and before the start of intervention a dentist will perform a periodontal examination, including bleeding on probing (BoP), probing pocket depth (PPD), determine lost teeth, mobility, furcation involvement and radiographic bone loss. Clinical measurements in addition to data on age and sex will be obtained from the clinics (TkNN) own medical record system. The participants will also be asked to fill out a digital questionnaire about weight and height, oral hygiene, oral health, and general health. The questions in the questionnaire will be repeated at the end of follow-up, in addition to questions on the whether or not the participants have taken the tablets as prescribed, their experienced in doing so, and finally on behaviors that affect vitamin D status (taken other supplements / use of solarium / sun holidays).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with chronic periodontitis according to the 2017 case definition
- •Adults, age group 20-60 years
- •Periodontitis Stage I-IV (2017 definition)
排除标准
- •Systemic illnesses (diabetes, osteoporosis)
- •Immuno-suppressive treatment
- •Pregnancy
- •Daily vit-D supplements
- •NSPT within 6 months
- •Local anti-microbial treatment
- •No natural teeth/peri implantitis
结局指标
主要结局
Change in periodontitis status after treatment (2017 case definition)
时间窗: Changes from baseline at week 11-13
Bleeding on probing (BOP)
次要结局
- Change in 25(OH)D after intervention(Changes from baseline at week 11-13)
- Change in biomarkers (IL-1β, IL-6, IL-8, IL-12, TNFα, CRP, MCP-1, MMP) over time as response to the intervention(Changes from baseline at week 11-13)
- Change in anti-microbial peptides (LL-37, hBD-2) after intervention(Changes from baseline at week 11-13)