A Randomized Clinical Trial to evaluate and compare antimicrobial efficacy of calcium hydroxide herbal Mimusops elengi and Tribulus terrestris as an intracanal medicament on Enterococcus faecalis in permanent teeth
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- To evaluate the antimicrobial efficiency of Mimusops elengi, Tribulus terrestris as an intracanal medicament on E.faecalis colony forming units over 30 days time period when compared with calcium hydroxide on permanent teeth by assessing history of pain tenderness on percussion absence of abscess or sinus discharge
研究概览
简要总结
Introduction: The root canal treatment focuses at the complete elimination of microbes from the pulp space. This is achieved through chemo-mechanical preparation followed by three dimensional obturation.
The persistent bacterium such as E. faecalis in the intricacies of pulp spaces poses a problem of endodontic treatment failure. To prevent such failures, Chemo-mechanical preparation along with the placement of intracanal medicament enhances the elimination of microbes and healing. Thus, this study aims to evaluate and compare antimicrobial Efficacy of calcium hydroxide, herbal Mimusops elengi andTribulus terrestris as an intracanal medicament on Enterococcus faecalis in permanent teeth.
Objectives: To evaluate and compare the antimicrobial efficacy of calcium hydroxide, herbal preparation of Mimusops elengi and Tribulus terrestris as an intracanal medicament on bacteria
Enterococcus faecalis by collecting the samples from root canals of permanent teeth.
Study design: 81 patients between the age of 6 to 14 years requiring root canal therapy will be selected for the study and will be randomly divided into 3 groups of 27 participants each namely:
oGroup A - Control; a mixture of Calcium Hydroxide with saline will be placed as an intracanal medicament.
oGroup B - a mixture of fine powder of Mimusops Elengi with saline will be placed as an intracanal medicament.
oGroup C - a mixture of fine powder of Tribulus Terrestris with saline will be placed as an intracanal medicament.
Three intracanal samples will be collected for each patient comprising of one baseline sample, two samples post placement of intracanal medicament after an interval of 15 and 30 days respectively. These collected samples will be sent to the laboratory for microbiological analysis to check the Colony Forming Unit counts of bacteria E.faecalis. The data collected will be tabulated and sent for statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Permanent teeth with periapical lesion requiring endodontic treatment.
- •2.Distinct periapical changes visible on intraoral periapical radiograph of permanent teeth.
排除标准
- •1.Teeth with evident clinical signs of extra oral swelling, space infections.
- •2.Patient on long-term antibiotic therapy, steroid therapy.
- •3.Patients with any systemic diseases.
- •4.Grossly decayed tooth indicated for extraction.
- •5.Parents who deny providing the consent and participation for the study.
结局指标
主要结局
To evaluate the antimicrobial efficiency of Mimusops elengi, Tribulus terrestris as an intracanal medicament on E.faecalis colony forming units over 30 days time period when compared with calcium hydroxide on permanent teeth by assessing history of pain tenderness on percussion absence of abscess or sinus discharge
时间窗: • 1st day –baseline sample collection for microbiological analysis of E.faecalis. | • 15 day follow up with sample collection for microbiological analysis of E.faecalis. | • 30 day follow up with sample collection for microbiological analysis of E.faecalis. | Time of assessment are first day 15th day and 30th day
次要结局
- To evaluate the success rate of endodontic therapy over a period of 30 days based on the parameters like absence of pain tenderness to vertical percussion discharge or swelling suggestive of periapical healing(15 days & 30 days post placement of intracanal medicament)
研究者
Dr Tejashwi K S
SDM College of Dental Sciences and Hospiatl