CTRI/2023/09/057700进行中（未招募）Unknown
An open label, single arm, multicentric clinical study to evaluate the efficacy and safety of HHTD-092201 (toothpaste) for Comprehensive Oral Care in Individuals with Diabetes - NI
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Subjects with history of diabetes with HbA1c 6.5 to 10% (as determined by HbA1c report not more than 1 month old)
- •2. Subjects currently under standard of care for diabetes control.
- •3. Subjects with age group 25 to 60 years
- •4. Subjects with mild to moderate periodontal complications as determined by Russell’s Periodontal Index
- •5. Subjects having at least 20 natural teeth
- •6. Willing to sign informed consent document and abide by the study procedures
排除标准
- •1. Subject with history of Periodontal treatment performed within last 6 months of study onset
- •2. Subjects with intrinsic dental stains like smokers, tobacco chewers, etc
- •3. Subjects with known history of hypersensitivity to any test product
- •4. Pregnant and lactating subjects (female with child-bearing potential enrolled after Negative Urine Pregnancy test and advised suitable contraceptive method)
- •5. Subjects with active infectious diseases or poor immunity (like known case of hepatitis, human immunodeficiency virus, tuberculosis) as determined by the investigator
- •6. Subjects using any other technique to clean teeth (including tobacco, plant sticks etc) apart from toothpaste and brushing
- •7. Subjects with poor oral hygiene or poor oral condition which may interfere with the study results as determined by the investigator
- •8. Subjects with known bleeding disorders or vitamin C deficiency
- •9. Subjects with previous oral surgery or permanent dental malformations (like oral cyst, tumors, etc)
- •10. Subjects with orthodontic appliance (like braces, brackets, wires, etc)
- •11. Subjects with recent history (within 3 months) of dental prosthetic appliances (like partial dentures)
- •12. Subjects with congenital abnormalities such as cleft lip, cleft palate, tethered labial frenulum, etc)
- •13. Subject with clinically significant medical or oral conditions (like serious diabetic macrovascular diseases, severely deranged kidney or liver functions, vasculitis) that might interfere with the outcome of the study as determined by the investigator
研究者
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