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临床试验/CTRI/2022/05/042944
CTRI/2022/05/042944尚未招募不适用

Comparative Evaluation of Lesion Sterilization and Tissue Repair in Pulpally Involved Primary Molars using Modified Triple Antibiotic Paste with Different Concentrations: An In Vivo Interventional Study

Dr Mainak Das1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2022年10月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
84
试验地点
1
主要终点
Decrease in pain, swelling and mobility (other than shedding mobility) in primary infected molars

研究概览

简要总结

Maintenance of primary dentition is imperative for the development of arch form, esthetics, function, mastication, and normal eruption of permanent teeth. Premature loss can cause various problems such as ectopic eruption, space loss for the successor permanent teeth, alterations in speech, and impairment of function. Hence, decayed primary teeth should not be extracted and treated whenever possible. Pulpectomy is generally recommended as a treatment of choice in such cases. But several factors make conventional pulpectomy arduous. The typical primary tooth morphology (tortuous root canals, presence of multiple accessory canals, ramifications, and ample medullary bone spaces that favor dissemination of infection) often presents a challenging task to the clinician. In addition to that, obtaining a hermetic seal is difficult due to the lack of apical closure following physiologic root resorption owing to the proximity of the developing permanent tooth germ to the roots of the primary teeth. A further challenge presented to the dentist in rendering effective endodontic treatment is the behavior management of uncooperative children. Thus to overcome these hurdles, the concept of lesion sterilization and tissue repair (LSTR) which involves the topical placement of triple antibiotic pastes (TAPs) evolved which aims to disinfect the canal space thus promoting repair of damaged tissue. LSTR involves the use of three antibiotics/antibacterial drugs namely, Metronidazole, Ciprofloxacin and Minocyclinewith macrogol (M) as the ointment base and propylene glycol (P) as the carrier.The prime concern regarding the use of triple antibiotic paste is the discoloration caused by minocycline. To overcome this, alternative medications such as clindamycin, cefaclor, amoxycillin have been proposed. The American Association of Endodontists (AAE) 2018 protocol recommends Triple Antibiotics Paste (TAP) should be mixed equally (1:1:1) to a final concentration of  1 – 5 mg/ml.At this concentration, TAP is conducive with stem cell survival and proliferation and also effective in eliminating microorganisms within the root canal. But no standardization regarding the dosage of drugs used in the antibiotic combination of LSTR in deciduous teeth has been done till date.

An in vivo interventional study will be conducted among children of age group 5-9 years with indication for pulp therapy using Modified Triple Antibiotic Paste (Ciprofloxacin, Metronidazole and Amoxicillin) with different concentrations (0.5 mg/ml, 2.5 mg/ml and 5 mg/ml) for LSTR of primary molars and comparative evaluation of clinical and radiographic success of LSTR will be done at specific time intervals.

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
5.00 Year(s) 至 9.00 Year(s)(—)
性别
All

入选标准

  • Children with deep caries involving pulp in primary molars, Irreversible pulpitis, Irreversible pulpitis with apical periodontitis, Primary molar with at least two-thirds of the roots, Primary molar with restorable crown structure.

排除标准

  • Primary molar with dentigerous cyst, Special children with a physical or emotional alteration, Children with systemic diseases, Previous history of allergy to antibiotics used in the study, Caries in primary teeth exhibiting pre-shedding mobility, Carious perforation of floor of primary molar, Molar with more than 2/3rd root resorbed, Molars with gross destruction of alveolar bone, Molar with non restorable crown structure.

结局指标

主要结局

Decrease in pain, swelling and mobility (other than shedding mobility) in primary infected molars

时间窗: 3, 6 and 12 months

次要结局

  • Radiographic evidence of decrease in intra radicular radiolucency, continuity of lamina dura and absence of internal resorption(6 and 12 months)

研究者

发起方
Dr Mainak Das
申办方类型
Other [self]

研究点 (1)

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