| CTRI Number |
CTRI/2023/10/058222 [Registered on: 03/10/2023] Trial Registered Prospectively |
| Last Modified On: |
14/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Wound Healing in tooth removal site |
|
Scientific Title of Study
|
Assessment of wound healing using different tissue regeneration materials in mandibular tooth extraction - A Prospective Study |
| 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 Rajesh P |
| Designation |
Professor and Head |
| Affiliation |
Department of Oral and Maxillofacial Surgery, Chettinad Dental College and Research Institute. |
| Address |
Room no 2, First floor, E block, Chettinad dental College and Research Institute , Rajiv Gandhi Salai,Kelambakkam Kancheepuram, Chennai
Room no 2, First floor, E block, Chettinad dental College and Research Institute , Rajiv Gandhi Salai,Kelambakkam Kancheepuram, Chennai
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9841016162 |
| Fax |
|
| Email |
rajeshomfs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shoba Narayan |
| Designation |
Associate Professor |
| Affiliation |
Chettinad Academy of Research and Education |
| Address |
Central Research Lab
Second Floor, Room no 1
Medical Bionanotechnology
Faculty of Allied Health Sciences
Chettinad Academy of Research and Education
Kelambakkam
India
Central Research Lab
Second Floor, Room no 1
Medical Bionanotechnology
Faculty of Allied Health Sciences
Chettinad Academy of Research and Education
Kelambakkam
India
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9840825263 |
| Fax |
|
| Email |
shobulu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh P |
| Designation |
Professor and Head |
| Affiliation |
Chettinad dental College and Research Institute |
| Address |
Roon no 2, first floor, Department of Oral and Maxillofacial Surgery, Chettinad dental College and Research Institute, Rajiv Gandhi Salai, Kelambakkam, Chennai
Roon no 2, first floor, Department of Oral and Maxillofacial Surgery, Chettinad dental College and Research Institute, Rajiv Gandhi Salai, Kelambakkam, Chennai.
TAMIL NADU
603103
India |
| Phone |
9841016162 |
| Fax |
|
| Email |
rajeshomfs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No 2, First floor, E Block, Chettinad Dental College and Research Institute, Rajiv Gandhi Salai, Kelambakkam, Chennai 603103. |
|
|
Primary Sponsor
|
| Name |
Dr. Rajesh P |
| Address |
Room No 2, First floor, E Block, Chettinad Dental College and Research Institute, Rajiv Gandhi Salai, Kelambakkam, Chennai 603103. |
| 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 |
| Dr Rajesh P |
Chettinad Dental College and Research Institute |
Room No 2,
First floor,
E Block,
Chettinad Dental College and Research Institute,
Rajiv Gandhi Salai, Kelambakkam, Chennai 603103.
Kancheepuram
TAMIL NADU |
9841016162
rajeshomfs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee for Faculty Research (CARE IHEC-II) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Physiological wound healing |
| Intervention |
Platelet rich fibrin
(PRF) |
PRF obtained from the patient through centrifugation method |
| Intervention |
PRF and Chitosan nanoparticles |
PRF obtained from the patient through centrifugation method mixed with Chitosan Nanoparticles |
| Intervention |
PRF and Silver Nanoparticles |
PRF obtained from the patient through centrifugation method mixed with Silver Nanoparticles |
| Intervention |
PRF and Silver nanoparticles and Chitosan nanoparticles |
PRF obtained from the patient through centrifugation method mixed with Silver nanoparticles and Chitosan nanoparticles |
| Intervention |
PRF and Silver nanoparticles and Chitosan nanoparticles and Titanium nanoparticles |
PRF obtained from the patient through centrifugation method mixed with Silver nanoparticles and Chitosan nanoparticles and Titanium nanoparticles |
| Intervention |
PRF and Silver nanoparticles and Titanium nanoparticles |
PRF obtained from the patient through centrifugation method mixed with Silver nanoparticles and Titanium nanoparticles |
| Intervention |
PRF and Titanium
nanoparticles and Chitosan nanoparticles |
PRF obtained from the patient through centrifugation method mixed with Titanium
nanoparticles and Chitosan nanoparticles |
| Intervention |
PRF and Titanium nanoparticles |
PRF obtained from the patient through centrifugation method mixed with Titanium Nanoparticles |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Extraction of permanent mandibuar molar teeth performed for several reasons including dental caries, periodontal disease, failed dental treatment, prosthetic indications and other reasons |
|
| ExclusionCriteria |
| Details |
Teeth which can be save endodontically
patient with systemic complication
Patient with bleeding disorders
Patients with Bone disorders |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain, inflammation and infection using Landry’s wound healing scale. |
3rd day, 7th day, 6th week and 12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
IPR scale will aso be used to assess the healing at the inflammatory,
proliferative and remodelling phases of wound healing |
3rd day , 7th day , 6th week and 12th week |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 2 |
|
Date of First Enrollment (India)
|
05/10/2023 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- 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 [rajeshomfs@gmail.com].
- For how long will this data be available start date provided 05-10-2023 and end date provided 05-10-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The aim of the study is to Compare analyse wound healing in extraction socket using platelet-rich plasma fibrin with or without platelet rich fibrin based nanocomposite. Patients who visited the department of oral and maxillofacial surgery, chettinad dental college and research institute, will be screened and patients indicated for tooth extraction according to the inclusion and exclusion criteria will be selected for the study and randomly grouped into 9 different groups with 10 each such as Group 1: control group Group 2 : Platelet rich fibrin (PRF) Group 3: PRF + Silver nanoparticles Group 4: PRF + Titanium nanoparticles Group 5: PRF + Chitosan nanoparticles Group 6: PRF + Silver nanoparticles + Titanium nanoparticles Group 7: PRF + Silver nanoparticles + Chitosan nanoparticles Group 8 : PRF + Titanium nanoparticles + Chitosan nanoparticles Group 9 : PRF + Silver nanoparticles + Chitosan nanoparticles + Titanium nanoparticles Extraction of mandibular teeth will be done for all the subjects under local anaesthesia followed by a tissue regeneration material. A follow up of the patient will be done on the 3rd day, 7th day, 6 weeks. The extraction site will be assessed for pain, inflammation and infection. Landry’s wound healing scale will be used to assess the healing process. IPR scale will aso be used to assess the healing at the inflammatory, proliferative and remodelling phases of wound healing. This will be done at the 3rd day corresponding to inflammatory phase, 7th day corresponding to the proliferative phase and after 6 weeks corresponding to the remodeling phase. In the study, appreciable amount of bone regeneration is expected to be observed in the experimental groups when compared to the control sites where no PRF was used. All the procedures performed in the study involves no risk or harm to the study population and complies with the ethical standards |