ISRCTN17731903已完成未知
A mixed methods feasibility study of electronic cigarette use by patients with periodontitis
ewcastle Upon Tyne Hospitals NHS Foundation Trust0 个研究点目标入组 80 人开始时间: 2016年9月27日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31171977 results (added 10/06/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged over 18 years old
- •2. Smoker of burnt tobacco (=10 factory-made cigarettes/day or 7 g [0.25 oz] loose tobacco or 14 hand-rolled cigarettes/day)
- •3. Not currently using an EC, or not used one for more than two days in the last 30 days
- •4. Be willing and able to come to the Dental Clinical Research facility in the Newcastle Dental Hospital for the required study visits
- •5. Minimum of 20 natural teeth (excluding third molars)
- •6. Diagnosed with severe chronic periodontal disease having interproximal pocket probing depths (PPDs) of =5 mm at =8 teeth and BOP scores =30%
- •7. Have read, understood and signed an informed consent form
排除标准
- •1. Having used an e-cigarette for more than 2 days in the last 30 days
- •2. Infectious or systemic diseases that may be unduly affected by participation in this study
- •3. Haemodynamically unstable patients hospitalised with severe arrhythmias, myocardial infarction, cerebrovascular accident
- •4. Suffering from Phaeochromocytoma
- •5. Suffering from uncontrolled hyperthyroidism
- •6. Liver or Kidney problems
- •7. Chronic Obstructive Pulmonary Disease
- •8. Patients taking the medication Adenosine
- •9. Lack of capacity to be able to consent to the research project and/or inability to follow study instructions
- •10. Participation in a dental research study within the previous 20 days
- •11. Pregnant by medical history, or nursing
- •12. Received any non-surgical periodontal therapy other than a routine scale and polish in the last 6 months
- •13. Currently undergoing or requiring extensive dental, orthodontic or implant treatment, or treatment for peri-implantitis
- •Eligibility Criteria requiring further discussions with individual participants:
- •1. Asthma (Severity needs to be assessed. Patient made aware that NRT better than smoking but best to use NRT as a short term stop smoking treatment).
- •2. Long term throat disease (Severity needs to be assessed. NRT use may exacerbate symptoms)
- •3. Stomach Ulcer, duodenal ulcer, irritation or inflammation of the stomach or throat (NRT may exacerbate symptoms)
- •4. Patient with diabetes mellitus will be advised to monitor their blood glucose more closely when initiating treatment. They will be advised to discuss this with their doctor or diabetic nurse.
- •5. Patients taking medications metabolised by CYP 1A2 and that have a narrow therapeutic window can be affected by stopping smoking. Patients taking theophylline, clozapine and ropinirole will be asked to see their doctor to discuss changing the dose prior to starting the quit attempt.
研究者
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