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CTRI Number  CTRI/2023/03/051198 [Registered on: 31/03/2023] Trial Registered Prospectively
Last Modified On: 27/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Compare and evaluate the effect of Intra-ligamentary and Supra periosteal injection technique using 2%Lignocaine Hydrochloride 1:80000 adrenaline in orthodontic extraction of maxillary premolars  
Scientific Title of Study   Comparative evaluation of Intra-ligamentary and Supra periosteal injection technique using 2%Lignocaine Hydrochloride 1:80000 adrenaline in orthodontic extraction of maxillary premolars- A Split mouth study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrMili Mehta 
Designation  MDS 3 
Affiliation  Dr D Y Patil Dental College and hospital Dr D Y Patil Vidyapeeth  
Address  Department of Oral and Maxillofacial Surgery Dr D Y Patil Dental College and hospital Dr D Y Patil Vidyapeeth Sant Tukaram Nagar Pimpri Pune
A-13 Yashwant CHS 90 ft Rd corner Ghatkopar East Mumbai 77
Mumbai
MAHARASHTRA
411018
India 
Phone  09920980314  
Fax    
Email  mehtamili95@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR Sonal B Shah  
Designation  Professor  
Affiliation  Dr D Y Patil Dental College and hospital Dr D Y Patil Vidyapeeth  
Address  Department of Oral and Maxillofacial Surgery Dr D Y Patil Dental College and hospital Dr D Y Patil Vidyapeeth Sant Tukaram Nagar Pimpri Pune
Sunflower Sukhwani Complex Vallabh Nagar Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA
411018
India 
Phone  9833459822  
Fax    
Email  sonal.shah@dpu.edu.in  
 
Details of Contact Person
Public Query  
Name  DR Sonal B Shah  
Designation  Professor  
Affiliation  Dr D Y Patil Dental College and hospital Dr D Y Patil Vidyapeeth  
Address  Department of Oral and Maxillofacial Surgery Dr D Y Patil Dental College and hospital Dr D Y Patil Vidyapeeth Sant Tukaram Nagar Pimpri Pune
Sunflower Sukhwani Complex Vallabh Nagar Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA
411018
India 
Phone  9833459822  
Fax    
Email  sonal.shah@dpu.edu.in  
 
Source of Monetary or Material Support  
Dr D Y Patil Dental College and hospital Dr D Y Patil Vidyapeeth Sant Tukaram Nagar Pimpri Pune 
 
Primary Sponsor  
Name  Dr Mili Mehta 
Address  Dr D Y Patil Dental College and hospital Dr D Y Patil Vidyapeeth Sant Tukaram Nagar Pimpri Pune 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
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 Mili Mehta   Department of Oral and Maxillofacial Surgery  Room No 9 3rd Floor ORal and Maxillofacial Surgery Department Dr D Y Patil Dental College and hospital Dr D Y Patil Vidyapeeth Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA 		 09920980314

mehtamili95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Sub Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: K011||Impacted teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intra-ligamentary injection technique   Using metal syringe with 1:80000 adrenaline twice  
Comparator Agent  Supra-periosteal injection technique  Using metal syringe with 1:80000 adrenaline 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. Patients indicated for bilateral maxillary premolar orthodontic extraction

2.Patients in the age group of 12 years and above.

3.Patients willing to participate in the study.

 
 
ExclusionCriteria 
Details  . Patient with pre-operative pain.
2. Patients with any local infection like abscess, swelling, etc
3. Patients allergic to Local anaesthesia.
4. Medically compromised patients.
5. Patient with history of bleeding disorders.
6.Pateints with Dilacerated root anatomy
7.Patients on antidepressant or anti-psychotic drugs.
  
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the pain perception felt during needle insertion, onset, duration and need for supplementary anaesthesia during supra periosteal injection technique and intra-ligamentary injection technique.

2.To compare the pain perception felt during needle insertion, onset, duration and need for supplementary anaesthesia during supra periosteal and intra ligamentary injection technique.
 		 immediate post op
 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of anesthesia  till anesthesia effect subsides 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   01/04/2023 
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="6"
Days="15" 
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  

A successful pain management through efficient local anesthesia is the basis for every dental therapy.  Patients always  expect a painless and comfortable dental procedure , which becomes very crucial  in subjects suffering from dental phobia. Several modifications have been made to modify the conventional procedures with newer  injecting devices, local anesthetic solutions and techniques to render the administration of LA comfortably.

In order to reduce the various complications associated with conventional injection techniques newer attempts were made to anesthetize single teeth directly without influencing the nerve structures of the surrounding tissues.

In 1920 Chompret published his experiences entitling his work "Anesthésie par injections intraligamenteuses" During the following decades the described technique of intraligamentary anesthesia (ILA) was refined simultaneously to the development of new anesthetically devices. 

 English medical literature search failed to reveal any study of the effect of intra ligamentary injections on sound teeth. Thus we intend to do a comparative study where we compare the efficacy of intra ligamentary and supra periosteal injection technique in orthodontic extraction of sound maxillary premolars and an age group of 12 years and above for the study to be reliable.

 
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