An in vivo comparative evaluation of Zinc Oxide-Propolis, Ozonated Oil-Zinc Oxide and Zinc Oxide Eugenol as obturating materials in primary molars
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- The evaluation of clinical and radiographic success rate of Zinc Oxide Propolis, Ozonated Oil Zinc Oxide and Zinc Oxide Eugenol as obturating materials in primary molar pulpectomy procedure over a follow up period of 3,6 and 9 months. Success will be determined using the Coll and Sadrian criteria(1996).
研究概览
简要总结
The selected teeth will be randomly divided into three groups according to the obturation material used:
Group I: Teeth to be obturated using Zinc Oxide-Propolis
Group II: Teeth to be obturated using a mixture of Ozonated oil-Zinc Oxide
Group III: Teeth to be obturated using Zinc Oxide Eugenol
Tooth preparation
The selected primary tooth will be isolated under rubber dam after the administration of local anesthesia. Access to pulp chamber will be gainedwith a sterile round bur #41 using a high-speed handpiece. Pulp extirpation will be done, followed by biomechanical preparation which will be initiated with a number 15-K file. The file will be used in a pull-back action and will be then sequentially increased up till the desired size. The length of the instrumentation will be deliberately kept 1mm short of the radiographic apex. Each level of instrumentation will be followed by irrigation with 1ml of 1% sodium hypochlorite and 2ml of normal saline. The canals will then be dried with sterile absorbent paper points before obturation. The prepared teeth will then be randomly and equally divided into three groups based on the obturating material used.
Group 1 (Zinc Oxide-Propolis): Zinc oxide powder and propolis liquid, is mixed onto a glass slab into a medium consistency and a suitable carrier is used to obturate the canals.
Group 2 (Ozonated oil-Zinc Oxide): Zinc oxide powder and ozonated oil liquid, is mixed onto a glass slab into a medium consistency and a suitable carrier is used to obturate the canals.
Group 3 (Zinc Oxide Eugenol): Zinc oxide powder and eugenol liquid, is mixed onto a glass slab into a medium consistency and a suitable carrier is used to obturate the canals.
Following obturation, all the selected teeth will then be restored using glass ionomer cement followed by stainless steel crowns.
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 8.00 Year(s)（—）
- 性别
- All
入选标准
- •1.The tooth should be restorable 2.Two-third of the root should be present 3.No radiographic evidence of internal or external pathological root resorption 4.No radiographic evidence of pulp floor perforations 5.No clinical or radiographic evidence of dentigerous cyst or follicular cyst or any pathology requiring enucleation 6.Tooth exhibiting all signs of irreversible pulpitis or necrotic pulp 7.When a planned tooth for pulpotomy shows excessive hemorrhage at the time of treatment 8.Co-operative and motivated patient.
- •9.Parents who are willing for the treatment, and have signed the informed consent form.
排除标准
- •1.Teeth with radiographic evidence of external or internal pathological root resorption 2.Periradicular pathosis involving the permanent tooth bud 3.Crown which is non-restorable 4.More than half of root resorbed 5.Presence of dentigerous cyst or follicular cyst 6.Loss of periodontal attachment with loss of bone support.
结局指标
主要结局
The evaluation of clinical and radiographic success rate of Zinc Oxide Propolis, Ozonated Oil Zinc Oxide and Zinc Oxide Eugenol as obturating materials in primary molar pulpectomy procedure over a follow up period of 3,6 and 9 months. Success will be determined using the Coll and Sadrian criteria(1996).
时间窗: immediately after obturation, at 3,6 and 9 months.
次要结局
- To evaluate the ease of application of Zinc Oxide Propolis, Ozonated Oil Zinc Oxide & Zinc Oxide Eugenol as obturating materials. Additionally the study will assess post operative discomfort & time taken for resorption of material as observed through follow up radiographs(Immediately after obturation, at 3, 6 & 9 months post operatively.)
研究者
Dr Meenu Bhola
Baba Farid University of Health Sciences