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CTRI Number  CTRI/2025/01/078981 [Registered on: 20/01/2025] Trial Registered Prospectively
Last Modified On: 07/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the healing of large bony lesion due to dead tooth/teeth, treated either with removal of dead tooth and placing it back after removing the infection from the root canal or doing surgery of that tooth/teeth or only root canal treatment. 
Scientific Title of Study   Healing outcome in nonsurgical root canal treatment versus periapical surgery versus Intentional replantation for management of large periapical lesion of Endodontic origin. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vineeta Nikhil 
Designation  Head of Department 
Affiliation  Subharti Dental College and Hospital/Swami Vivekanand Subharti University 
Address  Subharti Dental College and Hospital Swami Vivekanand Subharti University NH-58 Delhi-Haridwar bypass road Meerut
Subharti Dental College and Hospital Swami Vivekanand Subharti University NH-58 Delhi-Haridwar bypass road Meerut
Meerut
UTTAR PRADESH
250005
India 
Phone  9639002866  
Fax    
Email  endobyvineeta@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Tannu Singh 
Designation  Junior Resident 
Affiliation  Subharti Dental College and Hospital/Swami Vivekanand Subharti University 
Address  Department of Conservative Dentistry and Endodontics Subharti Dental College and Hospital Swami Vivekanand Subharti University campus NH-58 Delhi-Haridwar bypass road Meerut
Department of Conservative Dentistry and Endodontics Subharti Dental College and Hospital Swami Vivekanand Subharti University campus NH-58 Delhi-Haridwar bypass road Meerut
Meerut
UTTAR PRADESH
250005
India 
Phone  9818963433  
Fax    
Email  tannusingh136@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vineeta Nikhil 
Designation  Head of Department 
Affiliation  Subharti Dental College and Hospital/Swami Vivekanand Subharti University 
Address  Subharti Dental College and Hospital Swami Vivekanand Subharti University NH-58 Delhi-Haridwar bypass road Meerut
Subharti Dental College and Hospital Swami Vivekanand Subharti University NH-58 Delhi-Haridwar bypass road Meerut
Meerut
UTTAR PRADESH
250005
India 
Phone  9639002866  
Fax    
Email  endobyvineeta@gmail.com  
 
Source of Monetary or Material Support  
Department of Conservative Dentistry and Endodontics, Subharti Dental College and Hospital, NH-58 bypass, Meerut, 250005 India 
 
Primary Sponsor  
Name  Department of Conservative Dentistry and Endodontics 
Address  Subharti Dental College and Hospital Meerut 250005 
Type of Sponsor  Other [Private Dental College] 
 
Details of Secondary Sponsor  
Name  Address 
Subharti Dental College and Hospital  NH-58 bypass road, Meerut, 250005 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vineeta Nikhil  Subharti Dental College and Hospital  Department of Conservative Dentistry and Endodontics Room number 308
Meerut
UTTAR PRADESH 
9639002866

endobyvineeta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
University Ethical Committee (Medical) Swami Vivekanand Subharti University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intentional Replantation   Delibrate extraction of teeth for better visualization of the diseased part and placing it back in the socket which is of the recognized treatment protocol. The procedure is done in 15-20 mins.  
Comparator Agent  Nonsurgical root canal treatment  Access opening, followed by the cleaning, shaping and disinfection and obturation of the root canal system. The procedure done in multiple sitting, usually 3-4. 
Comparator Agent  Periapical surgery  Refelecting the mucosal flap over the infected site and removal of infection. The procedure is done for 2-3 hrs 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Radiographically diagnosed with large periapical lesion more than 10mm associated with maxillary anterior teeth.
Minimal marginal bone height of 2-3 mm.
Acceptable periodontal status (probing depth less than 4mm). 
 
ExclusionCriteria 
Details  Patients with systemic conditions which could compromise the healing.
Cysts of non-odontogenic origin.
Apico-marginal defect.
Developmental anomaly of a tooth (palate gingival groove, dilaceration, PCO etc
Cervical & External root resorption.
Non restorable and teeth with vertical root fractures.
Patients not willing to participate in the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the clinical and CBCT outcome of
maxillary anterior large periapical lesion of endodontic origin.
a) Treated with intentional replantation with periapical curettage.
b) Treated with periapical surgery.
c) Treated with nonsurgical root canal treatment. 
Patients evaluated at baseline; after treatment
for 1 week; 1 month and followed up for 6
months and 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
To identify the prognostic factors affecting the
outcome of large periapical lesion treated with intentional replantation.
2.To evaluate and compare the patient oral health related quality of
life after intentional replantation, periapical surgery and nonsurgical root canal treatment 
2 years 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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 3/ Phase 4 
Date of First Enrollment (India)   30/01/2025 
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)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [endobyvineeta@gmail.com].

  6. For how long will this data be available start date provided 02-03-2027 and end date provided 01-03-2032?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

Large periapical lesion (LPL) of endodontic origin are primarily caused by bacteria and their by-products emanating from the root canal system. These lesions are expected to heal if the source of infection (intracanal bacteria and bacterial-by products) is eradicated. Non-surgical root canal treatment (NSRCThas a good success rate for management of LCPL. However, NSRCT may require multiple visits. Hence, in many cases surgical intervention may be required. Despite the advances in periapical surgeries, some cases of LPL cannot be managed surgically due to surrounding anatomical or neurovascular structures (e.g.; proximity to the mental nerve or maxillary sinus), or lack of accessibility (e.g.; thick buccal bone, endodontic-periodontal lesion, repair of a palatal radicular groove or extensive root perforation). Moreover, periapical surgery is an invasive procedure which takes long intraoperative time period with possibility of post-operative swelling and pain. Intentional replantation (IR) is defined as a deliberate extraction of tooth, following which the tooth undergoes inspection, endodontic manipulation and repair and is then replanted back into the same socket . Intentional replantation (IR) results in elimination of diseased tissue, removes apical

ramifications and provides a better quality of apical seal due to the improved access and ease of manipulation. IR addresses both intraradicular and extra-radicular infection. In this regard, it offers benefits of both non-surgical endodontic treatment and peri-apical surgery. It offers several advantages with reduced morbidity; less invasive; less technique-sensitive procedure that can potentially be done by general dental practitioners and is more cost-effective. Moreover, IR is done within 15-20 minutes, with very less postoperative complications. The aim of the study is to evaluate and compare the CBCT outcome of non-surgical root canal treatment with intentional replantation and periapical surgery performed for management of maxillary anterior large periapical lesion of endodontic origin.

 
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