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临床试验/CTRI/2025/08/092409
CTRI/2025/08/092409尚未招募4 期

Clinical Comparison Of Egg Shell Powder Versus Nanohydrorxyapatite Powder as Indirect Pulp Capping Agents in Primary Molars

Dr Pendurkar Ekta Manohar1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月18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
60
试验地点
1
主要终点
Identify the most efficient pulp capping agents

研究概览

简要总结

Dental caries is a multifactorial disease characterized by the demineralization of inorganic substance of the tooth and the destruction of organic part of the tooth. Enamel of deciduous tooth is less mineralized, more susceptible to acid dissolution compared to enamel of permanent teeth.To preserve the integrity of tooth until their natural exfoliation, restorative procedures have to be performed. Treating reversible pulpal injuries and maintaining pulp vitality are the primary objectives of vital pulp therapy. Indirect pulp capping is a procedure where in small amount of carious dentin is retained in deep areas of cavity to avoid exposure of pulp, followed by placement of a suitable medicament and restorative material that seals off the carious dentin and encourages pulp recovery.  Most commonly used materials for indirect pulp capping are Calcium hydroxide, zinc oxide eugenol cement, MTA. Each of these materials have their own drawbacks. Nano- hydroxyapatite (NHA) particles have unique properties such as higher solubility, higher surface energy, and optimal biocompatibility compared to the typical hydroxyapatite. Synthetic NHA has the same physicochemical properties as those of apatite in the enamel. It shows strong affinity to the tooth and can strongly adsorb on enamel surfaces. Eggshell is a rich source of calcium. It contains 94% calcium carbonate, 1% calcium phosphate, 1% magnesium carbonate, and 4% organic matter. Egg Shell contains not only calcium but also other elements such as fluoride and strontium -despite the low concentration- and have a positive effect on bone and dental metabolism. In 1992, Egg shell powder was registered as a medicinal and pharmaceutical agent. However, the effects of Eggshell powder and Nano- hydroxyapatite powder on reparative and reactionary dentin formation in primary molars following application as an indirect pulp capping agent in deep carious lesions has not been documented. This study aims to evaluate the efficacy of Egg shell powder and Nano-hydroxyapatite powder as indirect pulp capping agents.

METHOD:

Study design: Randomized Clinical Trial

Sample size: 60 Children (30/Group).  Source of study: Department of Paediatric and Preventive Dentistry, VMSDC, Salem.

Inclusion Criteria:

No history of spontaneous and nocturnal pain

No history of swelling or sinus tracts

No radiographic signs of pathologic root resorption and furcation radiolucency

Dental caries involving more than 2/3rd of the dentin thickness not approaching pulp

Exclusion criteria:

Signs of irreversible pulpitis

Patients who are unwilling to participate in the study

Patients with systemic diseases/ physical disabilities

Randomization:

The randomization is achieved by simple randomization technique using lottery method.

Based on the inclusion criteria a total of 60 children in the age group of 5-10 years will be selected for the study, Study participants will be allocated into 2 groups, Following Rubber dam placement, soft caries (infected dentin) removal will be done using a slow speed handpiece and a carbide bur.

Group 1 Egg Shell Powder

Commercially available Egg shell powder will be mixed with saline and placed over the cavity floor with the help of cement carrier followed by restoration with glass ionomer cement.

Group 2 Nano-Hydroxyapatite powder will be mixed with saline and placed over the cavity floor with the help of cement carrier followed by restoration with glass ionomer cement.

Immediate postoperative periapical radiographs with IOPA grids will be taken with film holders in paralleling technique to check the correct placement of material which will serve as the baseline parameter for the further radiographic evaluation.

The patient will be followed up clinically for evaluation of pain and radiographically for the amount of reparative dentin thickness formed at the intervals of 2 months and 6 months respectively.

Clinical Assessment:

The evaluations will be performed at baseline of 2nd and 6th month intervals through a clinical examination according to Zurn and Seale pain rating scale, 2008.

Radiographic Assessment:

The evaluations will be performed at baseline of 2nd and 6th month intervals through a radiological examination. Radiographic success will be confirmed by the absence of any pathological root resorption, furcal radiolucency. IOPA grids which are made up of copper wire will be used with film holders. Paralleling technique will be used. The IOPA grids when superimposed with film, they show anatomic structures with grid lines. These grid lines are evenly distributed which is 1mm part length wise and width wise. The dentin remineralisation is evaluated by using digital radiographic technique superimposed with radiolucent grid lines.

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 Investigator Blinded

入排标准

年龄范围
6.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • No history of spontaneous and nocturnal pain No history of swelling or sinus tracts No radiographic signs of pathologic root resorption and furcation radiolucency Dental caries involving more than 2/3rd of the dentin thickness not approaching pulp.

排除标准

  • Signs of irreversible pulpitis Patients who are unwilling to participate in the study Patients with systemic diseases/ physical disabilities.

结局指标

主要结局

Identify the most efficient pulp capping agents

时间窗: 1. Pre-operative | 2. Post-operative (Immediate) | 3. Follow-up (2months) | 4. Follow-up (6months)

次要结局

未报告次要终点

研究者

发起方
Dr Pendurkar Ekta Manohar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Pendurkar Ekta Manohar

Vinayaka Mission Sankarachariyar Dental College

研究点 (1)

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