| CTRI Number |
CTRI/2025/01/078984 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
31/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
The clinical trial to study the effect of two different materials on bone healing in patients undergoing endodontic surgery |
|
Scientific Title of Study
|
Post Endodontic surgery bone healing comparison-Platelet Rich Fibrin and Bone Putty: A Randomized controlled trial |
| 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 PRAVIN KUMAR |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Dentistry, Block 2A, OPD Building, All India Institute of Medical Sciences, Jodhpur Jodhpur RAJASTHAN 342005 India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9818402220 |
| Fax |
|
| Email |
kumarpr@aiimsjodhpur.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PRAVIN KUMAR |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Dentistry, Block 2A, OPD Building, All India Institute of Medical Sciences, Jodhpur Jodhpur RAJASTHAN 342005 India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9818402220 |
| Fax |
|
| Email |
kumarpr@aiimsjodhpur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asna K A |
| Designation |
Post Graduate Student |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Endodontic section Department of Dentistry, Block 2A, OPD Building, All India Institute of Medical Sciences, Jodhpur Jodhpur RAJASTHAN 342005 India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9400736007 |
| Fax |
|
| Email |
asnakaroly@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,Department of Dentistry, Block 2A, OPD Building, Jodhpur
RAJASTHAN 342005 India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni Basni,Jodhpur, Rajasthan 342005 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Pravin Kumar |
All India Institute of Medical Sciences, Jodhpur |
Endodontic Section Block 2A second floor Department of Dentistry, Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005 Jodhpur RAJASTHAN
Jodhpur
RAJASTHAN |
9818402220
kumarpr@aiimsjodhpur.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K14||Diseases of oral cavity and salivary glands, (2) ICD-10 Condition: K04||Diseases of pulp and periapical tissues, (3) ICD-10 Condition: K048||Radicular cyst, (4) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bone Putty |
CBCT (3D) images of the region of interest will be taken, preoperatively. After an appropriate diagnosis, root canal treatment will be done as per protocol. During surgery, lesion contents will be enucleated, and after root end resection, inspection, and retrograde filling, the bony cavity will be filled with bone putty material. Primary closure will be done after repositioning the mucoperiosteal flap. The surgical healing can be evaluated by 3D software (ITK-SNAP) for CBCT analysis for assessing the reduction in the size of the lesion, on one year follow up post-surgically. Total Duration of procedure is 1 day |
| Comparator Agent |
Platelet Rich Fibrin |
CBCT (3D) images of the region of interest will be taken, preoperatively. After an appropriate diagnosis, root canal treatment will be done as per protocol. During surgery, lesion contents will be enucleated, and after root end resection, inspection, and retrograde filling, the bony cavity will be filled with platelet-rich fibrin. Primary closure will be done after repositioning the mucoperiosteal flap. The surgical healing will be evaluated by 3D software (ITK-SNAP) for CBCT analysis for assessing the reduction in the size of the lesion, on one year follow up post-surgically. Total Duration of procedure is 1 day |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients over the age of 16 years regardless of the gender.
2. Patients with large periapical lesions of endodontic origin.
3. Patients planned for surgical intervention subsequent to conventional endodontics. |
|
| ExclusionCriteria |
| Details |
1. Patients not planned for endodontic surgery.
2. All patients for medical reason who cannot undergo endodontic surgery because of systemic conditions
3. Patient denied to participate |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Extent of lesion will be calculated Supero-inferiorly, mesio-distally, bucco-lingually and assess the change in defect size and volume using CBCT volumetric analysis preoperatively and post operatively in one year of follow up |
Preoperatively and Post operatively (one year of follow up) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Amount of radiographic
bone fill will be calculated |
Pre operative and post operative (1 year of follow up) |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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 4 |
|
Date of First Enrollment (India)
|
29/01/2025 |
| 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="1"
Months="6"
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
|
In cases of significant bony defects, regeneration of the missing periapical tissue is extremely difficult. Periapical surgery uses a variety of bone transplant and regenerative materials. Bone replacement materials should be biocompatible, noncarcinogenic and should act as a scaffold for the development of new bone and gradually resorb to make room for it. Bone putty is a biomaterial that shows promising results in bone regeneration and healing. Using this bone putty, few case reports have shown healing with the development of mature bone in large periapical lesions of endodontic origin with palatal perforations. The second-generation platelet concentrates known as platelet-rich fibrin (PRF) is a rich source of growth factors and can be used to effectively induce tissue regeneration and repair. Cone beam computed tomography (CBCT) is a 3D imaging modality that provides high resolution distortion free images of the bone and surrounding structures. ITK-SNAP is an open-source software for quantifying the healing progress. Thus, the present study aims to correlate and compare bone healing with CBCT volumetric analysis after endodontic surgery using Bone putty as compared to Platelet Rich Fibrin, in one year follow up. A total of 44 patients who meet the inclusion criteria will be enrolled for clinical trial and two different materials (Platelet Rich Fibrin and Bone Putty) will be used in the bony defects. Preoperative to one year post operative reduction in volume (mm3) will be calculated and the mean values obtained for both the groups will be statistically analyzed and evaluated for any significant difference. |