ISRCTN31193447已完成未知
The effect of Plasma Rich in Growth Factors (PRGF) on periodontal tissue regeneration
niversity of Bristol (UK)0 个研究点目标入组 38 人开始时间: 2014年11月25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
- 38
研究概览
简要总结
2018 results in https://pubmed.ncbi.nlm.nih.gov/29382467/ (added 24/07/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Consent demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
- •2. Aged at least 18 years old
- •3. Understands and is willing, able and likely to comply with all study procedures and restrictions
- •4. Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral examination
- •5. Oral Cavity - Have at least 2 vertical interproximal periodontal defects in different quadrants of the mouth as evidenced by radiographic investigation
- •6. Oral Hygiene Status - Full mouth Turesky plaque index score <2
- •7. Non-Smoker - Participant must be a non-smoker or have stopped smoking for ?6 months prior to surgery
排除标准
- •1. Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
- •2. Women who are breast?feeding
- •3. Disease:
- •3.1. Current or recurrent disease/dental pathology that could affect the assessments
- •3.2. Bleeding disorders
- •3.3. Immuno-compromised
- •3.4. Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, or any medical disorder that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the study products or procedures
- •3.5. Tooth with >grade I mobility
- •4. Allergy/Intolerance Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- •5. Medication: Use of antibiotics one month prior to start of the study
- •6. Clinical Study/Experimental Medication: Participation in another clinical study or receipt of an investigational drug within 10 days of the screening visit
- •7. Substance abuse Recent history of alcohol or other substance abuse
- •8. Personnel A member of the study site or a family relative. The study site for this protocol is the Clinical Trials Unit in the Bristol Dental School and Hospital. Employees of the Bristol Dental School and Hospital not associated with the Clinical Trials Unit are eligible to participate
- •9. Any participant who, in the judgement of the investigator, should not participate in the study
研究者
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