| CTRI Number |
CTRI/2024/07/069712 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Platelet Rich Fibrin is Compared with Sticky Bone in the evaluation of Post Operative Healing Following Surgical Extraction of Third Molar-A Randomized Control Trail. |
|
Scientific Title of Study
|
To Evaluate the Efficacy of Sticky Bone versus Platelet Rich Fibrin in Promoting Healing Following Surgical Extraction of Mandibular Third Molar-A Randomized Control Trail |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sharanya Jillapally |
| Designation |
Junior Resident |
| Affiliation |
Government Dental College and Hospital,Mumbai |
| Address |
Government Dental College and Hospital, Mumbai
Department of Oral and Maxillofacial Surgery,
Room No-118.
In St. George Hospital Campus
Beside CSMT Railway Station
Mumbai
MAHARASHTRA
400001
India |
| Phone |
09505172342 |
| Fax |
|
| Email |
jillapallysharanya6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Jayant Landge |
| Designation |
Associate professor |
| Affiliation |
|
| Address |
Dr. Jayant S Landge
401, Sai Anant CHS
Plot No 15, Sector 12
Dutta Mandir Road
Kharghar, Navimumbai
Mumbai
MAHARASHTRA
410210
India |
| Phone |
9004799405 |
| Fax |
|
| Email |
drjayant27@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Sharanya Jillapally |
| Designation |
Junior Resident |
| Affiliation |
Government Dental College and Hospital,Mumbai |
| Address |
Government Dental College and Hospital, Mumbai
Department of Oral and Maxillofacial Surgery,
Room No-118.
Mumbai
MAHARASHTRA
400001
India |
| Phone |
9505172342 |
| Fax |
|
| Email |
jillapallysharanya6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government dental college and hospital,
Department of oral and maxillofacial surgery,
Room no 118,
In St. George Hospital Campus, Beside CSMT Station,India,Maharashtra, Mumbai,400001 |
|
|
Primary Sponsor
|
| Name |
Sharanya Jillapally |
| Address |
Government Dental College and Hospital,
Department of Oral and Maxillofacial Surgery,
Room No-118
Maharashtra, Mumbai,400001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrJillapally Sharanya |
Governement Dental College and Hospital, Mumbai |
Department of Oral and Maxillofacial Surgery
Room No-118
Mumbai
MAHARASHTRA |
09505172342
jillapallysharanya6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committe government dental college and hospital |
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 |
| Comparator Agent |
platelet rich fibrin |
Only once for 5mins the 20 cc of venous blood will be taken from the cubital vein
before the procedure and centrifuged at 2400–2700 rotations per minute (rpm) using a
specific centrifuge machine running at alternated and controlled speed for 2 min. The upper
layer of Autologous Fibrin glue thus prepared will be placed in the surgically extracted mandibular third molars |
| Intervention |
sticky bone |
Only once for 5mins the 20 cc of venous blood will be taken from the cubital vein
before the procedure and centrifuged at 2400–2700 rotations per minute (rpm) using a
specific centrifuge machine running at alternated and controlled speed for 2 min. The upper
layer of Autologous Fibrin glue thus prepared was aspirated and mixed with an alloplastic
(hydroxyapatite and tricalcium phosphate) particulate bone graft allowed to polymerize for
10–15 min to form Sticky Bone. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists Grade I patients. (Healthy patients)
Patients between the Age group of 21 - 60 years.
Patients requiring surgical removal of impacted third molars for prophylactic or
therapeutic reasons.
Patient willing to participate in the study and willing to come for a review
Pederson difficulty index with a tooth score of 5 or less will be included in the study.
|
|
| ExclusionCriteria |
| Details |
Medically compromised patients.
The patient is not willing to participate in the study.
Patient is allergic to any medications.
Acute infections or any carious tooth.
Pregnant and lactating mother.
Regional malignancy.
Individuals under anticoagulant therapy, anemia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain
Trismus
Swelling
Height of the bony socket |
Pain at 1st,3rd,7th post operative days
Trismus at 1st,3rd,7th post operative days
Swelling at 1st,3rd,7th post operative days
Height of the bony socket post operatively at preoperative, one month, three months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| complications |
post operatively
Immediate, one month, six months |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
22/07/2024 |
| 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="0"
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
|
To evaluate the efficacy of sticky bone versus platelet-rich fibrin in promoting the healing of surgically extracted mandibular third molars in a Randomized control trial.21-60 years of individuals will be included in the study variables are pain, trismus, swelling, height of the bony socket following extraction of the third molar postoperatively, the patient will be evaluated on 1,3,7 day for pain, swelling, trismus height of the bony socket will be evaluated 1, 3 months post operatively |