Evaluation of treatment outcome in terms of clinical and radiographic presentation of Chitra HAP-fil TM and Zinc oxide Eugenol as pulpectomy medicaments in primary mandibular molars- A Randomised controlled trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Radiographic Success assessed by RVG (Absence of: Furcation radiolucency, Abnormal root resorption, Deviated eruption of succedaneous teeth, Excess filling material and its resorption)
研究概览
简要总结
The primary teeth are implicated to be the best space maintainer and so it is of utmost responsibility of the pediatric dentists to take the necessary measures to protect the pulpally involved primary teeth. There are a lot of materials to fill the root canals but none of them have a biomimetic property. The material used in this study; Chitra HAP-FilTM is a hydroxyapatite-based nanoparticle gel having biomimetic property with similar crystallography as that of the hard tissues of the tooth.
Each tooth will be anesthetized and isolated using rubber dam. Following the access opening using sterile round carbide burs, the working length (WL) will be determined radiographically using RVG. Step-back mechanical preparation using kedo-files and endomotor will be done. This will be alternating with 1% sodium hypochlorite and normal saline irrigation. Obturation will be done using the respective materials in both the groups.
Group 1: Obturation using Chitra HAP-FilTM medicament.
Group 2: Obturation using Zinc Oxide Eugenol medicament.
Post-obturation restoration will be done with Glass ionomer cement followed by a stainless-steel crown placement. The clinical and radiographic outcome will be measured after 9 months for those patients reporting with an intact stainless-steel crown by an investigator blinded to the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 7.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with signs of irreversible pulpitis in primary mandibular molars.
- •Teeth should have adequate bone support with at least 2/3rd of intact root length with neither gingival swelling nor sinus tract.
排除标准
- •Grossly decayed teeth which cannot be restored.
- •Any pathologic signs of external or internal resorption of the roots.
- •Children with underlying systemic diseases and with special health care needs and those who exhibit negative and definitely negative Frankl behavior rating.
结局指标
主要结局
Radiographic Success assessed by RVG (Absence of: Furcation radiolucency, Abnormal root resorption, Deviated eruption of succedaneous teeth, Excess filling material and its resorption)
时间窗: 9 months post-intervention period.
次要结局
- Clinical success (Absence of Pain, Swelling, Fistulous opening, & Abnormal mobility)(9 month post-intervention period)
- Quality of Obturation assessed with RVG using Coll & Sadrian criteria, 1996.(Immediate post-intervention period)
研究者
Dr Sruthi Priyadharshiny S
Government Dental College, Kottayam