| CTRI Number |
CTRI/2025/03/082483 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Autologous Low concentration. of Platelet Rich plasma] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
An introduction of autologous Platelet rich plasma in the socket of removed lower 3rd molar teeth and study of the healing with its use in medically fit patients. |
|
Scientific Title of Study
|
An intervention of autologous Low Concentration Platelet Rich Plasma at surgically extracted mandibular 3rd molar site with a fractal viewpoint to scrutinize the changes - A pilot 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 |
Vaibhav Sheshrao Bibe |
| Designation |
PG student in oral and maxillofacial surgery |
| Affiliation |
Meenakshi Ammal Dental college and Hospital, Chennai |
| Address |
Department of Oral and maxillofacial surgery, room no.5, PG clinic, Meenkashi Ammal Dental College and Hospital, Alapakkam main road, Chennai
Chennai
TAMIL NADU
600095
India |
| Phone |
8626078175 |
| Fax |
|
| Email |
vaibhavbibe10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manodh P |
| Designation |
MDS - oral and maxillofacial surgery |
| Affiliation |
Meenakshi Ammal Dental college and Hospital, Chennai |
| Address |
Department of Oral and Maxillofacial Surgery, Room no.5, PG clinic, Meenkashi Ammal Dental College and Hospital, Alapakkam main road, Chennai
TAMIL NADU
600095
India |
| Phone |
9804439655 |
| Fax |
|
| Email |
drmanodh.omfs@madch.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Vaibhav Sheshrao Bibe |
| Designation |
PG student in oral and maxillofacial surgery |
| Affiliation |
Meenakshi Ammal Dental college and Hospital, Chennai |
| Address |
Department of Oral and Maxillofacial surgery, Room no. 5, PG clinic, Meenkashi Ammal Dental College and Hospital, Alapakkam main road, Chennai
Chennai
TAMIL NADU
600095
India |
| Phone |
8626078175 |
| Fax |
|
| Email |
vaibhavbibe10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Oral and Maxillofacial Surgery, Room no. 5 ,Meenakshi Ammal Dental college and hospital, Chennai, Tamil Nadu, India. 600095. |
|
|
Primary Sponsor
|
| Name |
Vaibhav Sheshrao Bibe |
| Address |
Department of Oral and Maxillofacial surgery, Room no.5, PG clinic,Meenakshi Ammal Dental College and Hospital, Alapakkam main road, Chennai, Tamil Nadu, India, 600095. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Vaibhav B |
Meenakshi Ammal Dental College and Hospital , Chennai. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vaibhav Sheshrao Bibe |
Meenakshi Ammal Dental College and Hospital, Chennai |
Department of Oral and Maxillofacial surgery, Room no.5, PG clinic,Meenakshi Ammal Dental College and Hospital, Alapakkam main road, Chennai, Tamil Nadu, India, 600095.
Chennai
TAMIL NADU |
8626078175
vaibhavbibe10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Meenakshi Ammal Dental College and Hospital, Chennai, Tamil Nadu, India, 600095. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Autologous Low concentration of Platelet Rich Plasma |
Autologous Low concentration of Platelet Rich Plasma will be introduced to the extraction site of impacted mandibular 3rd molar by injecting it into the socket for 10 seconds. |
| Intervention |
Autologous Low concentration of Platelet Rich Plasma impregnated silk sutures. |
Autologous Low concentration of Platelet Rich Plasma will be introduced to the extraction site of impacted mandibular 3rd molar by closure of the site with impregnated sutures for 3 minutes in low concentration Platelet rich plasma and injection of PRP in socket for 10 seconds. |
| Comparator Agent |
nil |
No introduction of any agent in the extraction socket of impacted mandibular 3rd molar, closure with normal silk suture. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II planned patients for surgical extraction of impacted mandibular 3rd molars without pathology. |
|
| ExclusionCriteria |
| Details |
Pathology associated with mandibular 3rd molar to be extracted.
Patients with systemic conditions and diseases like Hypertension, Diabetes Mellitus, AIDS or immunosuppressive diseases, bleeding disorders, bone disorders; pregnant or lactating women; patients allergic to lidocaine, paracetamol or ibuprofen; patients in whom the administration of epinephrine is contraindicated, smokers, alcohol abuse, patients who presented with a jawbone-associated pathology and non-co-operative patients (psychic-motor dysfunction and behaviour disorders), ASA 3, 4 and 5 |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
A better healing at the surgical site without reduced chances of post-op infection and
trismus.
Reduction in the perception of post-op pain which is a major factor causing discomfort to the patient.
Rapid closure of the wound.
Rapid bone formation thus with a greater amount of density and mineral content |
24 hours, 3rd day, 7th day, 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Early epithelialisation of the wound.
2) reduction in pain .
3) increase in density of bone. |
7th day, 14th day. 3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
10/04/2025 |
| 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="0"
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
|
The pilot study titled "An intervention of autologous Low Concentration of Platelet-Rich Plasma impregnated sutures at surgically extracted mandibular 3rd molar site with a Fractal viewpoint to scrutinize the changes" aims to explore the effects of low concentration platelet-rich plasma (L-PRP) infused sutures on healing following the extraction of mandibular third molars. The objectives of the study include assessing wound epithelization, bone density, mineral content at the extraction site after a healing period of 10-12 weeks, intensity of post-operative pain, degree of trismus, and the inflammatory response on the suture surface. The study is designed as a prospective, randomized control trial with a sample size of 30 participants (10 in each group), focusing on patients aged 25-50 undergoing surgical extraction of mandibular third molars. Parameters evaluated in the study include: - Epithelization Status: Analyzing the healing of the wound.
- Bone Density and Mineral Content: Assessing alveolar bone conditions after healing with fractal dimensions.
- Pain Levels: Measurement via a Visual Analogue Scale at various intervals (24 hours and 3 days post-surgery).
- Trismus: Evaluating the extent of restricted jaw opening.
- Inflammatory Cell Count: Examining the suture surface at the surgical site.
The study anticipates providing insightful data on the efficacy of L-PRP in enhancing post-operative recovery in oral surgeries |