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CTRI Number  CTRI/2023/07/055065 [Registered on: 11/07/2023] Trial Registered Prospectively
Last Modified On: 10/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   A study of alternate method to root canal treatment in kids teeth 
Scientific Title of Study   Evaluation of lesion sterlisation and tissue repair (LSTR) technique for the treatment of non-vital primary molars present with pathological resorption 
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 Anushi Mehandiratta 
Designation  PG Student 
Affiliation  SGT Dental College, Hospital and Research Institute , SGT University, Gurgaon , Haryana 
Address  Room no 6, Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences, SGT University, Gurgaon

Gurgaon
HARYANA
122505
India 
Phone  8091794193  
Fax    
Email  anu.meh101@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR Anushi Mehandiratta 
Designation  PG Student 
Affiliation  SGT Dental College, Hospital and Research Institute , SGT University, Gurgaon , Haryana 
Address  Room no 6, Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences, SGT University, Gurgaon


HARYANA
122505
India 
Phone  8091794193  
Fax    
Email  anu.meh101@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR Shalini Garg 
Designation  Professor 
Affiliation  SGT Dental College, Hospital and Research Institute , SGT University, Gurgaon , Haryana 
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  
 
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 
Dr Anushi  SGT hospital and research center,SGT University, Chandu Bhudera, Gurugram, Haryana  Room no. 6, Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences , SGT university, Gurugram, Haryana Gurgaon HARYANA
Gurgaon
HARYANA 
8091794193

anu.meh101@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI GURUGOBIND SINGH TRICENTENARY UNIVERSITY, GURUG RAM,HARYANA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  PATHOLOGICAL ROOT RESORPTION 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Lesion Sterlisation and Tissue Repair in the treatment of non vital primary molars in non resorb root  40 children among 3-8 years with restorable posterior teeth were selected. clinical examination will be conducted at baseline, 3, 6, 9 and 12 months follow up and radiographic examination will be conducted at 6 and 12 months follow up 
Intervention  Lesion Sterlisation and Tissue Repair in the treatment of non vital primary molars in resorb root  40 children among 3-8 years with restorable posterior teeth were selected. clinical examination will be conducted at baseline, 3, 6, 9 and 12 months follow up and radiographic examination will be conducted at 6 and 12 months follow up 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  1. Age group – 3-8yrs
2. Restorable teeth.
 
 
ExclusionCriteria 
Details  Patient with any systemic disease.  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The aim of this case control study is to compare the success of lesion sterlisation & tissue repair in resorb & non resorb teeth   the clinical follow up will be assessed at baseline 3 6 9 and 12 months and radiographic follow up will be done at 6 and 12 months  
 
Secondary Outcome  
Outcome  TimePoints 
To maintain the primary tooth as a natural space maintainer.   clinical 3, 6, 9, 12 months
radiographical 6 & 12 months.  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   28/07/2023 
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="1"
Months="0"
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  

Preservation of the primary tooth is the best method of space maintenance for its successor. However, teeth with infected root canals are a common clinical problem. Pediatric dentists routinely counter primary teeth showing signs of irreversible pulpitis and pulpal necrosis. The treatment in such cases are conventional approach or teeth extraction. Conventional root canal was introduced in early 1932 to save primary teeth that otherwise would have been extracted. Conventional endodontic therapy is aimed at elimination of microorganisms from the infected root canals and prevention of reinfection. Premixed calcium hydroxide and iodoform paste is a universally accepted obturating material for pulpectomy in primary teeth. However, root resorption of primary molars has been found to be accelerated following pulpectomy with conventional iodoform containing filling materials, leading to their early shedding in comparison with homologous teeth without endodontic treatment. 

The further challenge presented to the pediatric dentist in such conditions where extraction has to be advised and pulpectomy can’t be done in cases of pathological like internal or external root resorption. Premature loss of primary teeth bring about disturbances like ectopic eruption, altered eruption sequence, crowding, delayed eruption, space loss, functional and speech impairment. So, these types can be managed with  86.4% of success rate with LSTR.

Hoshino of Niigata University School of Dentistry invented the concept of LSTR therapy in 1990, and popularized by Takushige , in which a mixture of antibacterial medications was used to sterilise root canals. These new medication combinations were discovered to be capable of sterilising carious lesions as well as infected necrotic pulps of deciduous teeth. It has been also demonstrated that having LSTR in resorbed teeth, the periradicular radiolucent lesions like inflammatory root resorptions disappeared or reduced, thus the lesions repaired. 

Keeping in view all these things, this technique which is less invasive, less time consuming, and come with primary aim of elimination of all the microorganism i.e, sterilization of root canal spaces which results in good healing. This proves to the beneficial alternative to the conventional root canals which has limitations in various fields like extensive root resorption, inadequate bone, and periodontal support, a child belonging to pre-cooperative age group, and which is also less time consuming and can be done in one or two sittings. 

As it needs the application of a different antibiotic combinations known as "Triple Antibiotic Paste" (TAP) which was developed in major part by Hoshino and colleagues . Eventually, the antibiotic paste and its impact on microorganisms present in carious dentine and diseased pulp received special attention. The results indicated that the microorganisms had been completely removed from the radicular system. TAP is a triple antibiotic that contains ciprofloxacin, metronidazole, and minocycline. TAP can affect both gram-negative and gram-positive bacteria, and this combination can be effective against odontogenic microorganisms .

Numerous studies have found that minocycline causes tooth discoloration . So, in this vivo study we are using Double Antibiotic Paste(DAP) as it was found to cause minimum or no tooth discoloration in comparison to minocycline containing TAP

Thus, in this present case control study we will compare the success of LSTR technique in non vital primary teeth with and without incidence of pathological resorption using DAP with propylene glycol as vehicle.

 
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