| 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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [endobyvineeta@gmail.com].
- 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.
- 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 (NSRCT) has 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. |