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CTRI Number  CTRI/2025/08/092409 [Registered on: 05/08/2025] Trial Registered Prospectively
Last Modified On: 01/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Clinical Comparison of Egg shell powder versus Nano hydrorxyapatite Powder as Indirect Pulp Capping Agents in Primary Molars 
Scientific Title of Study   Clinical Comparison Of Egg Shell Powder Versus Nanohydrorxyapatite Powder as Indirect Pulp Capping Agents in Primary Molars 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pendurkar Ekta Manohar 
Designation  Post Graduate 
Affiliation  Vinayaka Mission Sankarachariyar Dental College 
Address  Room No 6 Department Of Pediatric and Preventive Dentistry Vinayaka Mission Sankarachariyar Dental College NH 47 Sankari Main road Ariyanoor Salem

Salem
TAMIL NADU
636308
India 
Phone  8355803238  
Fax    
Email  empendurkar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Veena Arali 
Designation  Professor and HOD 
Affiliation  Vinayaka Mission Sankarachariyar Dental College 
Address  Room No 6 Department of Pediatric and Preventive Dentistry Vinayaka Mission Sankarachariyar Dental College NH 47sankari Main road Ariyanoor salem

Salem
TAMIL NADU
636308
India 
Phone  9894810759  
Fax    
Email  aparnavvarthan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pendurkar Ekta Manohar 
Designation  Post Graduate 
Affiliation  Vinayaka Mission Sankarachariyar Dental College 
Address  Room no 6 Department of Pediatric and Preventive Dentistry Vinayaka Mission Sankarachariyar Dental College NH 47 Sankari Main road Ariyanoor salem

Salem
TAMIL NADU
636308
India 
Phone  8355803238  
Fax    
Email  empendurkar@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Pendurkar Ekta Manohar 
Address  Room no 6 Department of Pediatric and Preventive Dentistry Vinayaka Missions Sankarachariyar Dental College NH-47 Sankari main road Ariyanoor Salem - 636308 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pendurkar Ekta Manohar  Vinayaka Mission Sankarachariyar Dental College  Room no 6 Department of Pediatric and Preventive Dentistry NH-47 Sankari main road Ariyanoor Salem - 636308
Salem
TAMIL NADU 
8355803238

empendurkar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee of VMS Dental College Salem  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Dental Treatment 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Egg Shell Powder  1 spoon of Egg shell Powder will be mixed with 2 drops of saline and placed in primary molars  
Comparator Agent  Nano-Hydroxyapatite powder  1 spoon of Nano Hydroxyapatite Powder will be mixed with 2 drops of saline and placed in primary molars 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  Signs of irreversible pulpitis
Patients who are unwilling to participate in the study
Patients with systemic diseases/ physical disabilities 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Identify the most efficient pulp capping agents  1. Pre-operative
2. Post-operative (Immediate)
3. Follow-up (2months)
4. Follow-up (6months) 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   18/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  18/08/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.


 
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