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CTRI Number  CTRI/2021/09/036129 [Registered on: 01/09/2021] Trial Registered Prospectively
Last Modified On: 31/08/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Pulp Capping Agent to Induce Calcific Bridge Formation. 
Scientific Title of Study   "Histological Evaluation of Ability of Calcium Hydroxide, Adhesive System & PRF as Pulp Capping Agent in Inducing Calcific Bridge Formation: an ex-vivo study" 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ekta Choudhary 
Designation  Professor and Head 
Affiliation  SDS, Sharda University 
Address  Department of Conservative Dentistry and Endodontics SDS, Sharda University. Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9818452508  
Fax    
Email  ekta.choudhary@sharda.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Ekta Choudhary 
Designation  Professor and Head 
Affiliation  SDS, Sharda University 
Address  Department of Conservative Dentistry and Endodontics SDS, Sharda University. Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9818452508  
Fax    
Email  ekta.choudhary@sharda.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Priya Jain 
Designation  MDS Student 
Affiliation  SDS, Sharda University 
Address  Department of Conservative Dentistry and Endodontics SDS, Sharda University. Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone    
Fax    
Email  priyajain.skj24@gmail.com  
 
Source of Monetary or Material Support  
School of Dental Sciences, Sharda University 
 
Primary Sponsor  
Name  Sharda University 
Address  32-34 Knowledge park III, Greater Noida. 
Type of Sponsor  Research institution and hospital 
 
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 Ekta Choudhary  Department of Conservative dentistry and Endodontics,SDS, Sharda University  Department of Conservative dentistry and Endodontics, SDS, Sharda University 32-34, Knowledge park III, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH 		 9818452508

ekta.choudhary@sharda.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
School of Medical sciences and research Hospital,Sharda University, Institutional Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified, (2) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Pulp capping agent  Platelet rich fibrin Calcium Hydroxide Adhesive system 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Thirty fully erupted maxillary and mandibular third molars of patients.
Indicated for extraction for orthodontic or surgical purpose 
 
ExclusionCriteria 
Details  Dental caries, cracks, developmental defects, fractured and restored teeth. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate & compare the ability of Calcium Hydroxide, Adhesive System and Platelet Rich Fibrin as Pulp capping agent in inducing calcific bridge formation.  2years 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the ability of Calcium Hydroxide as pulp capping agent in inducing calcific bridge formation.
To evaluate the ability of Adhesive System as pulp capping agent in inducing calcific bridge formation.
To evaluate the ability of Platelet Rich Fibrin as pulp capping agent in inducing calcific bridge formation.
 		 6mths 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   01/10/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Histological evaluation of ability of Calcium Hydroxide, Adhesive System & Platelet Rich Fibrin as pulp capping agent in inducing calcific bridge formation.

 

The Research will Include Fully erupted third molar in which Teeth will be mechanically cleaned and disinfected with 0.2% chlorhexidine solution.

Administration of Local Anaesthesia & Application of Rubber Dam will be done and a Class I Cavity will be prepared, after this Area measuring approximately 1-1.5 mm in diameter will be exposed under air-distilled water cooling in the centre of the pulp floor and the Bleeding will be controlled with saline irrigation and a sterile cotton pellet.

Pulp Capping of the tooth will be done using three different material and lastly will be restored using Glass Ionomer Cement and Composite resin.

 

Evaluation of pulp status based on patient-reported symptoms using a verbal pain intensity scale, clinical examinations, and thermal and electrical tests.

The clinical assessment after 1 week and after 6 weeks of observation, directly before tooth extraction.

Extraction of the teeth with minimal trauma only after all the parameters have been satisfied.

The extracted teeth will then be subjected to Histological analysis on the H&E stained specimens using an optical microscope.

 

4. Research objectives.

·         To evaluate the ability of Calcium Hydroxide as pulp capping agent in inducing calcific bridge formation.

·         To evaluate the ability of Adhesive System as pulp capping agent in inducing calcific bridge formation.

·         To evaluate the ability of Platelet Rich Fibrin as pulp capping agent in inducing calcific bridge formation.

·         To evaluate & compare the ability of Calcium Hydroxide, Adhesive System and Platelet Rich Fibrin as Pulp capping agent in inducing calcific bridge formation.

 

5. Research methodology (detailed description of the materials and methods).

Sample size - Thirty fully erupted maxillary, and mandibular third molars from patients.

 

Radiographic Examination will be done to exclude the presence of caries or periapical pathology.

Use of Electric Pulp Tester to check the vitality of the pulp.

Teeth will be mechanically cleaned and disinfected with 0.2% chlorhexidine solution.

Administration of Local Anaesthesia & Application of Rubber Dam

Preparation of Conventional occlusal Class I Cavities under air-distilled water cooling using round diamond bur (ISO Size 012).

Area measuring approximately 1-1.5 mm in diameter will be exposed under air-distilled water cooling in the centre of the pulp floor using round carbide bur (ISO Size 012).

Bleeding will be controlled with saline irrigation and a sterile cotton pellet. And Pulp capping will be done using three different materials:

Group 1: Calcium Hydroxide

Group 2: Adhesive System

 

Group 3: Platelet Rich Fibrin

 

After Pulp Capping the tooth is restored using Glass Ionomer Cement and Composite resin.

 

Evaluation of pulp status based on patient-reported symptoms using a verbal pain intensity scale, clinical examinations, and thermal and electrical tests.

The clinical assessment after 1 week and after 6 weeks of observation, directly before tooth extraction.

Pain will be assessed using verbal pain intensity scale, which is a list of verbal descriptors defining pain, such as the following:

Absent, weak, moderate, and strong.

To analyze the duration of pain, we used the following classification:

0, no pain; 1, symptoms lasting for one day; 2, symptoms lasting for 2–7 days; 3, symptoms lasting longer than 7 days.

An electrical test using Electrical Pulp Tester. (Repeated 3 times)

Radiographic Examination in order to evaluate the status of the periapical tissues, presence of deposits in the pulp chamber, and the presence of internal or external resorption.

Extraction of the teeth with minimal trauma.

The extracted teeth will be fixed in 10% buffered formalin solution.

Demineralization in nitric acid, and embedded in paraffin.

Two- to 3-micron thick serial sections, cut in the lingual-buccal plane, will be stained with haematoxylin and eosin (H&E).

Bacterial detection using the Brown and Brenn technique.

Histological analysis on the H&E stained specimens using an optical microscope.

Investigations of the sectioning under normal and ultraviolet (UV) light using 38 HE eGFP (which will clearly illustrate the physiological secondary dentin and the original dentin) and 43 HE Cy3 filters (clearly illustrating the kernel odontoblasts and blood cell counts).

 
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