| CTRI Number |
CTRI/2022/08/044676 [Registered on: 05/08/2022] Trial Registered Prospectively |
| Last Modified On: |
19/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study To Compare The Periapical Lesion Healing Of Necrotic Teeth With Regenerative Endodontic Procedures Along With Or Without Laser Therapy. |
|
Scientific Title of Study
|
A Comparative Evaluation Of Periapical Healing Of Non Vital Teeth With Regenerative Endodontic Procedures And Photo Bio-stimulation Therapy.
- A Randomized Controlled Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikhil Nagari |
| Designation |
Post Graduate |
| Affiliation |
Kamineni Institute of Dental Sciences |
| Address |
Conservative Dentistry and Endodontics Department, Room No. 7, First floor, Kamineni Institute of Dental Sciences, Narketpally, Nalgonda, 508254.
Nalgonda
TELANGANA
508254
India |
| Phone |
7981934393 |
| Fax |
|
| Email |
nnikhil003@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Jayaprada Reddy |
| Designation |
Professor |
| Affiliation |
Kamineni Institute of Dental Sciences |
| Address |
Conservative Dentistry and Endodontics Department, Room No. 7, First floor, Kamineni Institute of Dental Sciences, Narketpally, Nalgonda, 508254.
Nalgonda
TELANGANA
508254
India |
| Phone |
9703936020 |
| Fax |
|
| Email |
drsjayapradareddy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nikhil Nagari |
| Designation |
Post Graduate |
| Affiliation |
Kamineni Institute of Dental Sciences |
| Address |
Conservative Dentistry and Endodontics Department, Room No. 7, First floor, Kamineni Institute of Dental Sciences, Narketpally, Nalgonda, 508254.
Nalgonda
TELANGANA
508254
India |
| Phone |
7981934393 |
| Fax |
|
| Email |
nnikhil003@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kamineni Institute of Dental Sciences. Conservative Dentistry and Endodontics Department, Room No. 7 , First floor, Narketpally, Nalgonda District, Telangana, 508254. |
|
|
Primary Sponsor
|
| Name |
Nikhil Nagari |
| Address |
Conservative Dentistry and Endodontics Department, Room No. 7, First floor, Kamineni Institute of Dental Sciences, Narketpally, Nalgonda, 508254. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nikhil Nagari |
Kamineni Institute of Dental Sciences |
Conservative Dentistry and Endodontics Department, Room No. 7, First floor, Narketpally, Nalgonda, 508254.
Nalgonda
TELANGANA |
7981934393
nnikhil003@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe of Kamineni Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Laser and T-PRF Revascularization |
Laser is used along with T-PRF and revascularization technique to promote healing of periapical lesion and regaining pulp sensibility of non vital tooth.
Laser spool tip is inserted inside the root canal 1mm short of working length and irradiation done for about 1minute on 0th day, 7th day and 14th day. Then Titanium PRF is placed and sealed with biodentine, Glass ionomer cement and composite on top of the root canal of the tooth. |
| Comparator Agent |
T-PRF Revascularization |
Titanium PRF is used along with revascularization technique to promote healing of periapical lesion and regaining pulp sensibility of non vital tooth.
Titanium PRF is placed inside the root canal after the canal is debrided completely by following proper irrigation protocol and by placing intracanal medicaments in between visits. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Non vital anterior tooth with single root canal and mature root apex and periapical lesion of PAI score greater than equal to 3. |
|
| ExclusionCriteria |
| Details |
Tooth with open apex, resorption, calcified canals, curved root anatomy, developmental defects, previously root canal treated, teeth requiring post cementation are excluded.
Patients with any systemic diseases and bleeding disorders are excluded. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hard Tissue (Bone) formation at periapical region of tooth at 3 months, 6 months, 9 months and, 12 months. |
Baseline, 3 months, 6 months, 9 months and, 12 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tooth sensibility at 3 months, 6 months, 9 months and, 12 months. |
Baseline, 3 months, 6 months, 9 months and, 12 months. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/08/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized , double blind , active arm trial to compare and assess
the radiographic healing of periapical lesion and the possibility of regaining pulp sensibility in
mature permanent teeth with necrotic pulp that is treated by
revascularization technique using
T-PRF assisted with low level laser therapy and T-PRF alone. |