A Randomized clinical trial comparing the outcomes of revascularization in immature non-vital permanent teeth using the calcium hydroxide and triple antibiotic paste as an intracanal medicament- A pilot exploratory study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To evaluate the clinical success of revascularization procedure in immature non-vital permanent teeth using the calcium hydroxide and triple antibiotic paste as an intracanal medicament
研究概览
简要总结
Revascularization is a regenerative treatmentmodality which has been advocated for management immature non-vital permanentteeth. It can lead to root development, thickening of dentinal walls andreestablishment of vitality. Root canal disinfection is a pre-requisite for anyregenerative endodontic procedure for which intracanal medicaments have beenfound very crucial role. Thus, this research is planned to assess the outcomes ofrevascularization in immature non-vital permanent teeth using the calciumhydroxide and triple antibiotic paste as an intracanal medicament. The Aim was to evaluate theoutcomes of revascularization in immature non-vital permanent teeth using thecalcium hydroxide and triple antibiotic paste as an intracanal medicament- Theobjective was to clinically and radiographicallyevaluate the outcomes of revascularization in immature non-vitalpermanent teeth using the calcium hydroxide and triple antibiotic paste as anintracanal medicament. This study will be carried out in the Division of Pedodontics andPreventive Dentistry, CDER, AIIMS, New Delhi. The Study duration was 2 yearsand sample size was T]total 20 teeth (10 in each group). The treatment plan andprognosis would be explained to the parents and a written informed consent willbe obtained. In the first visit, after access cavity will be prepared. Canalswould be irrigated followed by placement of intracanal medicament. Randomallocation would be done using computer-generated sealed envelope technique intotwo groups 1. Calcium hydroxide 2. Triple antibiotic paste. For the secondvisit, the patient will be recalled after 2 weeks to evaluate the clinicalsigns and symptoms. Intracanal medicament would be removed followed byinduction of bleeding into the root canal to allow the clot formation to occurfollowed placement of MTA over the blood clot and final restoration. Forfollow-up clinical evaluation- patient will be assessed for clinical signs andsymptoms at 3,6 and 12 months. Radiographic evaluation- Patient will beassessed for increase in root length and root width and resolution ofpreoperative radiolucency at 3, 6 and 12 months. Vitality assessment-Vitalitytesting will be done at 3, 6 and 12 months postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 7.00 Year(s) 至 14.00 Year(s)(—)
- 性别
- All
入选标准
- •Participant’s age should be 14 years or less
- •Immature non-vital permanent teeth as a result of trauma or dental caries
- •Teeth should be in nollas stage 7, 8 or 9 of tooth development
- •Consent for participation and willingness for the treatment.
排除标准
- •Denied consent or not willing for participation
- •Presence of any systemic/hematological disorder that can affects outcome of the procedure
- •Patient is allergic to calcium hydroxide or triple antibiotic paste.
结局指标
主要结局
To evaluate the clinical success of revascularization procedure in immature non-vital permanent teeth using the calcium hydroxide and triple antibiotic paste as an intracanal medicament
时间窗: 3, 6 and 12 months
次要结局
- 1.To evaluate the radiographic success of revascularization procedure in immature non-vital permanent teeth using the calcium hydroxide and triple antibiotic paste as an intracanal medicament(2.To evaluate and compare the pulp vitality outcomes of revascularization using calcium hydroxide and triple antibiotic paste as an intracanal medicament)
