ISRCTN64254080已完成4 期
Adjunctive antimicrobial therapy of Periodontitis: long-term effects on disease progression and oral microbiological colonisation
niversity Hospital Muenster (Germany)0 个研究点目标入组 500 人开始时间: 2007年3月30日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
研究概览
简要总结
2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/26250060 (added 19/02/2019) 2016 sub-analysis results in: https://www.ncbi.nlm.nih.gov/pubmed/27393928 (added 19/02/2019) 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30326764 (added 19/02/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 01/08/2008:
- •Subjects selected for the study must meet the following inclusion criteria:
- •1. Periodontal Screening Index (PSI) of IV in at least one sextant
- •2. Range from 18 to 75 years of age with clinical and radiographic signs of moderate (Clinical Attachment Loss [CAL] of 3 to 4 mm) to severe (CAL 5 mm or more) chronic or aggressive periodontitis
- •3. At least 10 natural teeth in situ
- •4. Pocket Probing Depths (PPDs) of greater than or equal to 6 mm at a minimum of four teeth
- •5. Willingness to participate and to be available at all times required for participation
- •6. Willingness to abstain from using antimicrobial mouth-rinses during the study except for those explicitly prescribed
- •7. The informed consent signed by the patient
- •8. Sufficient knowledge of German language
- •Previous inclusion criteria:
- •Subjects selected for the study must meet the following inclusion criteria:
- •1. Periodontal Screening Index (PSI) of IV in at least one sextant
- •2. Range from 18 to 75 years of age with clinical and radiographic signs of moderate (Clinical Attachment Loss [CAL] of 3 to 4 mm) to severe (CAL 5 mm or more) chronic or aggressive periodontitis
- •3. At least 10 natural teeth in situ
- •4. Pocket Probing Depths (PPDs) of greater than or equal to 6 mm at a minimum of four teeth
- •5. No professional periodontal therapy during the six months preceding the baseline clinical evaluation, and willingness to participate and to be available at all times required for participation
- •6. Willingness to abstain from using antimicrobial mouth-rinses during the study except for those explicitly prescribed
- •7. The informed consent signed by the patient
排除标准
- •Current exclusion criteria as of 01/08/2008:
- •1. Report themselves confirmed or assumed allergies or hyper-sensitive skin reactions against amoxicillin, metronidazol or lactose, or in parents or siblings
- •2. Have Downs syndrome
- •3. Known acquired immune deficiency syndrome (AIDS)/human immunodeficiency virus (HIV)
- •4. Regularly take drugs that may affect the periodontal conditions, e.g. phenytoine, nifedipine, and/or steroid drugs
- •5. Professional periodontal therapy during the six months preceding the baseline clinical evaluation
- •6. Require antibiotic treatment for dental appointments
- •7. Are undergoing or require extensive dental or orthodontic treatment
- •8. Are pregnant or breastfeeding
- •9. Have rampant caries
- •10. Have any oral or extra-oral piercing in or around the oral cavity with ornaments or accessory jewellery
- •11. Are dental students or dental professionals
- •12. Have participated in a clinical dental trial in the six months preceding the study
- •13. Cognitive deficits
- •Previous exclusion criteria:
- •1. Report themselves confirmed or assumed allergies or hyper-sensitive skin reactions against amoxicillin, metronidazole or lactose, or in parents or siblings
- •2. Have Down?s syndrome, known Acquired Immune Deficiency Syndrome (AIDS)/Human Immunodeficiency Virus (HIV) or deregulated diabetes type one or two as determined by assessment of erythrocyte HbA1c levels (more than 6.5%)
- •3. Regularly take drugs that may affect the periodontal conditions, e.g. phenytoine, nifedipine, and/or steroid drugs
- •4. Require antibiotic treatment for dental appointments
- •5. Are undergoing or require extensive dental or orthodontic treatment
- •6. Are pregnant or breastfeeding
- •7. Have rampant caries
- •8. Have any oral or extra-oral piercing in or around the oral cavity with ornaments or accessory jewellery
- •9. Are dental students or dental professionals, or have participated in a clinical dental trial in the six months preceding the study
- •10. Cognitive deficits
- •11. Insufficient knowledge of German language
研究者
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