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临床试验/CTRI/2025/07/091633
CTRI/2025/07/091633尚未招募4 期

Comparative evaluation of clinical and radiographical success of pulpectomized primary molars using three herbal additives to zinc oxide as obturating materials :A 12 month followup study

Dr Marathe Sanveed Sunil1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年9月21日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Compare and evaluate success rate of herbal additives to zinc oxide as obturating materials in pulpectomized primary molars

研究概览

简要总结

The complex root canal system of primary teeth makes it difficult to achieve proper chemomechanical debridement Hence obturating materials having good antimicrobial properties is crucial for better prognosis Conventional materials like zinc oxide eugenol and calcium hydroxide have been successfully used as obturating materials in pediatric endodontics but have limited anti-microbial action Herbal alternatives that have therapeutic and broader and more effective antibacterial properties are being exploredCurcumin the bioactive component of turmeric has wide spectrum of anti-inflammatory antioxidant anti-carcinogenic anti-bacterial and anti-fungal propertiesAzadirachta Indica Neem has immunomodulatory antifungal antimicrobial anti-inflammatory and anti-oxidant propertiesPropolis a natural bee hive product contains flavanoids phenolics and other aromatic compounds which has potent antibacterial and anti-inflammatory properties Over the years several undermining disadvantages like periapical irritation inflammation and cemental necrosis have emerged Considering the effective and beneficial properties of Curcumin Neem and Propolis the aim of this in vivo study is to evaluate and compare the clinical and radiographical success of three different herbal additives to Zinc Oxide as obturating materials at 3 6 9  12 months 

  • | | | | | --- | --- | --- | |An aseptic technique will be used throughout the endodontic treatment. A single visit or multi visit pulpectomy will be performed by single operator using basic behaviour management techniques. Topical anesthetic gel will be applied. 2% lignocaine is administered at site after sub cutaneous patch test through 2.5ml disposable luerlock syringe. Rubber dam isolation will be done. The access to pulp chamber will be done with sterile water cooled high speed handpiece using diamond round bur (#330) followed by Endo Z after removal of carious tooth structure. The coronal pulp will be removed with help of spoon excavator. The radicular pulp is extripated using a barbed broach. The working length will be recorded using intraoral periapical radiograph 1 mm short of radiographic apex using Ingle’s method. Biomechanical preparation will be done using K files with step back technique along with thorough and copious irrigation with saline and 2.5% Sodium Hypochlorite.
The prepared teeth will be randomly divided into 4 experimental groups and will be obturated

·         Experimental Group I – 25 teeth will be obturated using Zinc Oxide and Eugenol

(Control)

·         Experimental Group II - 25 teeth will be obturated using Zinc Oxide + Curcumin

·         Experimental Group III - 25 teeth will be obturated using Zinc Oxide + Neem

·         Experimental Group IV - 25 teeth will be obturated using Zinc Oxide + Propolis

 Paper points are used for drying the canals prior to obturation.

SUCCESS OF OBTUARTED MATERIALS WILL BE  DETERMINED BY

·         CLINICAL CRITERIA

·         RADIOGRAPHICAL CRITERIA

CLINICAL CRITERIA                                                   SCORING CRITERIA

·         Presence/absence of Pain                                                    Absence – 0

·         Presence / absence of Gingival Swelling /Abscess             Presence - 1

·         Presence/absence of Mobility

·         Presence / absence on Tenderness On Percussion

 The numerical value of Score 0 will be given for Absence of and Score 1 will be given for Presence of the symptoms.

·         RADIOGRAPHICAL CRITERIA                                  SCORING CRITERIA

·         Presence/Absence of Periradicular and Furcal Radiolucency

·         Presence/Absence of Internal Root Resorption                      Absence – 0

·         Presence/Absence of External Root Resorption                     Presence – 1

The numerical value of Score 0 will be given for Absence of and Score 1 will be given for Presence.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
5.00 Year(s) 至 9.00 Year(s)(—)
性别
All

入选标准

  • Tooth with presence of deep carious lesion or teeth having carious exposure to pulp Tooth with radiographic evidence of deep carious lesion and 2/3rd of root length present having adequate bone coverage Tooth with presence or absence of intraradicular or periradicular radiolucency not involving permanent tooth bud.
  • Tooth with any sign of inflammation if present.

排除标准

  • Teeth with extensive root resorption Teeth that present pathological mobility or mobility due to physiologic resorption Non restorable primary molars Teeth with perforated pulpal floors Teeth with inadequate bone support Children with intake of antibiotics 2 weeks prior to treatment Fractured teeth Children with major systemic illness.

结局指标

主要结局

Compare and evaluate success rate of herbal additives to zinc oxide as obturating materials in pulpectomized primary molars

时间窗: Base line | 3 month | 6 month | 9 month | 12 month

次要结局

未报告次要终点

研究者

发起方
Dr Marathe Sanveed Sunil
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Marathe Sanveed Sunil

Rajarajeswari dental college and hospital, Bangalore

研究点 (1)

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