跳至主要内容
临床试验/CTRI/2025/07/090981
CTRI/2025/07/090981尚未招募2 期

Comparative evaluation of antimicrobial effectiveness of photodynamic therapy using curcumin and beta vulgaris extract in teeth with periapical pathology :An in vivo study

URMY1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年8月5日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
Reduction in microbial load in root canal samples following photodynamic therapy with Curcumin and Beta vulgaris extract

研究概览

简要总结

Need for the study-

 Despite the promising individual outcomes of curcumin and beetroot as natural photosensitizers  in vitro models there is a lack of comparative in vivo studies evaluating their antimicrobial effectiveness in teeth with periapical pathology. The clinical relevance of these agents in real-time biological environments remains underexplored.

Thus, a study comparing curcumin mediated aPDT and beetroot mediated aPDT following standard chemo mechanical preparation, could provide valuable insight into their relative efficacy biocompatibility and potential as low cost natural alternatives for endodontic disinfection.

This study is a randomized double blind parallel group  single centre trial wherein the effect of photodynamic therapy using curcumin and beet root extract on the microbial load in teeth with periapical pathology is assessed.

Brief summary of the process

METHODOLOGY:

Obtaining the herbal extracts:

The herbal extracts Curcumin and Beta vulgaris will be obtained from AGHP enterprises Chennai India and manufacturer has given authentication certificate for the herbal extracts.

 Preparation of irrigation solution:

Beta vulgaris and Curcumin will be dissolved in a DMSO to a concentration of 0.5 mg per mL

 Access opening and Chemomechanical preparation

 Patients reporting to the department of Conservative Dentistry and Endodontics with complaint of pain will be screened for eligibility after assessing the inclusion and exclusion criteria for this in vivo study .

Healthy patients ,between 18 to 55 years will be shortlisted. The participants will be allotted to  2 different groups by randomization.

After explaining each patient about the study and procedure they will be asked to sign an informed consent form.

After administration of local anaesthesia rubber dam isolation will be obtained access opening will be done and working length will be measured using J morita root ZX 2 PLUS endomotor.The root canal contents  that is dentinal shavings will  be collected  in normal saline in eppendoff tube before  proceeding for chemomechanical preparation.This will be sample 1.

Chemomechanical preparation will be performed with protaper gold of Dentsply til F1 or F2 according to manufacturer’s instructions using 3 percent  NaOCl,saline  and EDTA 17 percent  as irrigating solutions alternatively .Canal instrumentation is either done by crown down or hybrid method depending upon the canal configuration. To neutralize NaoCl the root canal contents will be rinsed with 1 mL 5 percent  sodium thiosulphate and 1 mL of normal saline for 30 seconds. The root canal contents that is dentinal shavings will collected in normal saline  before  proceeding for photodynamic therapy.This will be sample 2.

 Photodynamic therapy

Depending on the group assigned curcumin or beet root photodynamic therapy will be done . The respective photosensitizers will be injected into the root canals and remained for 120 seconds prior to irradiation with Novolase dual wave endo laser. PDT will be carried out for 120 seconds by means of a Novolase dual wave endo laser with a power peak at 640 nm and output intensity of 240 mw per cm square. The irradiation will be  performed using an endodontic tip of 0.5 mm diameter which will be  introduced into the canal up to ½ of the working length.Immediately after photodynamic therapy, the root canals were irrigated with 5mL of sterile saline solution for complete removal of the photosensitizer. The root canal contents that is dentinal shavings will be collected which will be the final sample.This will be sample 3.

Microbiological culture

The shavings that is all the three samples will then be transferred into eppendorf tubes containing 1 ml of normal saline and will be vortexed for 1 minute. The diluted bacterial suspensions will be cultured on Blood  agar plates using the Spread plate technique. After 24 hours of incubation colony forming units  will be counted using a colony counter. The actual bacterial counts will be calculated reported as CFU per mL for each sample .

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 and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Healthy patients Single rooted teeth with pulp necrosis and radiographic size of peri apical lesion of diameter 2 to 5 mm.
  • Potential to achieve canal patency The candidates ability to understand and provide informed consent.

排除标准

  • Teeth with incomplete formation of roots Radiographic size of periapical lesion of diameter geater than 5 mm Presence of resorption or obliterated root canals and root fractures Periodontal pockets deeper than 3 mm that is teeth with poor prognosis or any recent history of trauma.
  • Those teeth from patients who had reported the use of anti inflammatory antibiotics and or immunosuppressive medications within the preceding 14 days for antibiotics and 3 to 5 days for antiinflammatory drugs or any systemic disease were not included in the study.

结局指标

主要结局

Reduction in microbial load in root canal samples following photodynamic therapy with Curcumin and Beta vulgaris extract

时间窗: AFTER 48 HOURS

次要结局

未报告次要终点

研究者

发起方
URMY
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Urmy

Maratha Mandal Nathajirao G Halgekar Institute of Dental Sciences and Research centre

研究点 (1)

Loading locations...

相似试验