Protective Effects of Allium Sativum and Moringa Oleifera Extract in Alleviating Lead Induced Defects on Dental Enamel of Rabbits
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Histological Outcomes
研究概览
简要总结
Primary objective is to observe the effects of lead on dental enamel of rabbit by measuring;
- Structural and morphological change by SEM, AFM
- Elemental composition by SEM-EDX
- Molecular composition and hydroxyapatite crystal changes by Raman Spectroscopy
- Blood parameters by serum analysis Secondary objectives includes
- To compare the protective effects of Allium sativum and Moringa oleifera on dental enamel defects due to lead
- To determine the beneficial effects of AS and MO extract in remineralization of dental enamel.
详细描述
This Animal experimental study will be carried out in animal House, University of Health Sciences, Lahore (UHS) and COMSATS University, Lahore. For this study fifty four healthy male, white NewZeeland rabbits (9 to 10 weeks) will be taken for the study. Rabbits will be randomly divided into 6 groups. Sample size will be 9 rabbits in each group. Experimental animals will be assigned number 1,2,3,4, till 54 using the random number generator and the randomly divided into six groups (n=9) and will be assigned as group A, B, C, D, E, and F. Healthy male, white New Zeeland rabbits weighing 1000-1200 grams (Age 9-10 weeks) will be selected from University of Veterinary and Animal Sciences, Lahore. The animals will be shifted to animal house of UHS. Animals will be kept in experimental research laboratory at controlled room temperature (22-24°C) and humidity (45-65 %) under 12/12 hours natural light and dark cycle for 2 weeks to acclimatize in new environment. All experimental animals will be fed on vegetables, fruits and distilled water ad libitum. At the end of 12 weeks, all the animals will be sacrificed under deep anesthesia. Ketamine hydrochloride 45 mg/kg b.w and xylazine 5 mg/kg b.w I/M will be given to maintain deep anesthesia. Afterwards, 20 mg xylazine was injected into the pinna vein to sacrifice the rabbits while they were anesthetized.(35).
Blood Sampling: The Central Auricular Artery(36) or lateral saphenous vein will be selected to collect 4 ml blood on day 0, after 8 weeks and at the end of 12 weeks. The sample will be collected in serum separating tube for investigations like blood lead count, alkaline phosphatase, calcium and phosphate level.
Tissue Sampling Technique:
A portion of 4x5 mm2 from middle third of crown labial surface will be taken for investigations. The cutting will be done by diamond disc and high speed turbine with irrigation of water to ovoid over heating of sample. Right mandibular incisors of all the rabbits will be selected for SEM and AFM. The left mandibular incisors of all the rabbits will be selected SEM-EDX and RMS analysis. All samples will be labeled and stored in sterilized container having 12% formalin for 72 hours.
Laboratory Processing:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
It is an animal model study and the investigator will mask the groups as "A, B, C, D, E, F" so the outcome assessor will be blinded.
入排标准
- 年龄范围
- 3 Months 至 5 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Healthy rabbits
- •Rabbits Age 9-10 weeks
- •Weight 1000-1200 g will be selected
排除标准
- •Diseased rabbit
- •Age: More than 10 weeks and less than 9 weeks
- •Weight more than 1200 g and less than 1000 g
结局指标
主要结局
Histological Outcomes
时间窗: at the end of the study
In this examination Odontoblastic zone, Cell nuclei Vacuolization of odontoblasts, Acute Inflammation, Chronic Inflammation, Apatite formation, Collagen crosslinking will be determined inform of normal or abnormal.
次要结局
- Mineral Concentration(at the end of the study)
研究者
Arslan Saleem
Statistical Officer
Rashid Latif Medical College