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CTRI Number  CTRI/2021/05/033850 [Registered on: 28/05/2021] Trial Registered Prospectively
Last Modified On: 27/05/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Regenerative Treatment for young traumatized teeth 
Scientific Title of Study   “REGENERATIVE ENDODONTIC TREATMENT IN NON-VITAL IMMATURE VERSUS MATURE PERMANENT INCISORS – A CLINICAL STUDY” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Taruna 
Designation  PG student 
Affiliation  SGT University 
Address  Room no. 6, Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences, SGT University, Gurgaon

Gurgaon
HARYANA
122505
India 
Phone  9899917559  
Fax    
Email  tarunayadav313@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shalini Garg 
Designation  Professor 
Affiliation  SGT University 
Address  Room no. 6, Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences, SGT University, Gurgaon

Gurgaon
HARYANA
122505
India 
Phone  9215668621  
Fax    
Email  shaloosandeep@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Taruna  
Designation  PG student 
Affiliation  SGT University 
Address  Room no. 6, Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences, SGT University, Gurgaon

Gurgaon
HARYANA
122505
India 
Phone  9899917559  
Fax    
Email  tarunayadav313@gmail.com  
 
Source of Monetary or Material Support  
SGT Dental College, Hospital and Research Center, SGT University, Budhera, Gurugram. 
 
Primary Sponsor  
Name  SGT University 
Address  Faculty of Dental Sciences, SGT University, Gurugram-122505 
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 
Taruna  SGT Hospital and Research centre, SGT University, Budhera, Gurgaon  Room no. 6, Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences, SGT University, Gurgaon
Gurgaon
HARYANA 
9899917559

tarunayadav313@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SHREE GURU GOBIND TRICENTENARY, GURUGRAM, HARYANA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Tooth pulpitis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Immature teeth  Rvascularization procedure will be done in immature teeth by using Biodentine. 
Intervention  Mature teeth  Revascularization procedure will be done in mature teeth by using Biodentine. 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  13.00 Year(s)
Gender  Both 
Details  1. Young non-vital permanent incisors both immature
and mature traumatized teeth.
2. Complete and Incompletely formed root.
 
 
ExclusionCriteria 
Details  1. Children with any major illness or any history
of systemic disease.
2. Teeth undergoing root resorption.
3. Teeth with excessive bone loss and questionable
prognosis.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The elimination of symptoms and the evidence of bony healing.  Clinical evaluation to be done at baseline, further at 3,6,9 and 12 months.
Radiographic evaluation to be done at 6 and 12 months. 
 
Secondary Outcome  
Outcome  TimePoints 
Positive response to pulp sensibility testing.  Clinical evaluation to be done at baseline, further at 3,6,9 and 12 months.
Radiographic evaluation to be done at 6 and 12 months. 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   07/06/2021 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

In Dentistry, it is always a primary concern to preserve the dentition. But when the pulp is necrotic or damaged, we try to restore it by artificial restorative materials. The endodontic procedures have some major limitations in the tooth such as – Discoloration, Prone to fracture, devitalization of tooth. Overtime, these filling materials cause severe destruction to the tooth structure and its longevity is severely compromised. Therefore, we need to use natural method instead of artificial ones to maintain the vitality of tooth. So, after the introduction of calcium silicate materials and tissue regeneration based approaches, we are looking forward to use these biological resources to preserve the tooth.

Pulp regeneration treatment has gained popularity in the recent years. Firstly, it was performed by Nygaard-Ostby in 1961. As per the American Association of Endodontists (AAE), the major aim of revascularization procedure is to eliminate the symptoms and encourage the natural healing of the tooth. The regenerative treatment can be done both in teeth with mature roots (closed apices) and immature roots (open apices). Usually, when the immature permanent teeth undergo any trauma or infection, it is conventionally treated by apexification or revascularization. Apexification is a procedure to induce a calcific barrier at the root apex. There are many drawbacks of apexification which include: long and multiple treatment sessions, stunted root development, unfavorable crown-root ratio, thinning of root canal walls which leads to brittle tooth structure and prone to fracture after post-endodontic restoration.

On the other hand, revascularization procedure/pulp dentin regenerative therapy promotes the natural development of continuous root formation and thickening of root canal walls as well as the apical closure. Thereby, eliminating the risk of root fracture. Revascularization treatment yields better results in case of pulpal necrosis due to traumatic injuries as compare to other etiological factors due to absence of bacteria associated with caries. There are mainly three key factors for the success of tissue regeneration, which involves namely, (a) Adult stem cells – have the capacity to form hard tissue (b) Signaling molecules cause cellular stimulation, proliferation and differentiation (c) A three dimensional (3-D) physical scaffold for viable growth and differentiation on the cellular level in regenerative endodontic procedures. 

                                                                                                                                                                                      Young tissue may react differently to regenerative treatment before and after the root formation in non-vital incisors with etiologic of trauma. It may be due to the difference in size of apical foramen, stage of maturogenesis at the time of trauma difference in type of pulp developing structure and its microanatomy. So, the present study is planned to know the effect of regenerative endodontic treatment in management of traumatized, non-vital, immature versus mature permanent incisors.


 
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