Comparative clinical and radiographic evaluation of mixtures of Zinc oxide – tulsi extract, Zinc oxide - ozonated oil and Zinc oxide eugenol as obturating materials in primary molars: An in vivo study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- When both clinical and radiographic success criteria are taken into consideration, the overall success rate of ZnO-ozonated oil is 93.3 %, zinc oxide tulsi extract is 87% and that of ZOE is 70 %
研究概览
简要总结
Introduction
Thebest space maintainer in both primary and mixed dentition is the primary toothitself. Thisis not only because of the clinical crown, but also due to the presence of theroots and periodontium that guide the eruption of the succedaneous permanent tooth. Thus, preserving the integrity of primary dentition is important forthe adequate development of permanent dentition. Primaryteeth should be preserved until they are ready to be replaced. Thus, primarytooth pulpectomy should be done as a routine procedure after proper examinationand diagnosis confirms its necessity. In view of this, endodontic treatment isconsidered the last option for keeping a primary tooth that has irreversiblyaffected pulp tissue, due to caries or traumatic lesions, in a child.Presently, the mostcommonly used primary teeth root canal filling materials is zinc oxide. It has been reported thatzinc oxide eugenol is an irritant to the periapical tissues doesnot resorb at the same rate as the roots and has lessantimicrobial activity. It has been found that eugenol is generally cytotoxic at high concentrationsand has an adverse effect on fibroblasts and osteoblast-like cells. Tulsihasbeen examined pharmacologically for antimicrobial, immunomodulatory,anti-inflammatory, hypoglycemic,chemoprotectiveand analgesic activities. Ozonehas bactericidalaction,debriding effect, angiogenesis stimulation capacityand highoxidising power. So that we can replace zinc oxide eugenol with zinc oxide tulsi extract and zinc oxide ozonated oil.
Aim
To evaluate and to compare invivo, the clinical and radiographic success of mixtures of zinc oxide –tulsi extract, zinc oxide - ozonated oil and zinc oxide eugenol as obturatingmaterials in pulpectomy of primary molars.
Method
Methodology:
A totalof 90 infected primary mandibular molar teeth of healthy children (age 4–9years) will be included in the study. These infected primary molars will be randomly allocated in three groups i.e zinc oxide tulsi extract, zinc oxide ozonated oil and zinc oxide eugenol. these willl be mixed in powder: liquid ratio of 4:1 and the root canals will be obturated using the same. a clinical follow-up will be taken after a period of 1 month and the radiographic follow-up will be taken after a period of 6 and 12 months.
Expected conclusion:
When both clinical and radiographic success criteria are taken into consideration, the overall success rate of ZnO-ozonated oil is 93.3 %, zinc oxide tulsi extract is 87% and that of Zinc oxide eugenol is 70 % approximately
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •Co-operative child Patient with clinical characteristics showing one or more signs and symptoms like (a) spontaneous pain or tender to percussion, (b) deep caries with pulp exposure, (c) uncontrolled hemorrhage after removal of coronal pulp tissue, (d) presence of chronic apical abscess or sinus tract, and (e) the tooth should be restorable.
- •Radiographic characteristics include (a) coronal‑radiographic evidence of a deep carious lesion or lesion approximating pulp (b) radicular‑ (i) discontinuity of lamina dura and (ii) furcation involvement less than or equal to half of shortest root in vertical dimension.
排除标准
- •Non-restorable teeth Teeth with physiologic root resorption more than one third of its length or if they have the presence of obliteration of the root canal Excessive internal resorption Internal calcifications Perforation into the bifurcation Dentigerous cysts.
- •Patients with any systemic illness or with the previous history of allergy to the antibiotics to be used in the study.
结局指标
主要结局
When both clinical and radiographic success criteria are taken into consideration, the overall success rate of ZnO-ozonated oil is 93.3 %, zinc oxide tulsi extract is 87% and that of ZOE is 70 %
时间窗: Radiographic outcome will be taken at 6 months and 12 months
次要结局
未报告次要终点