| CTRI Number |
CTRI/2022/10/046471 [Registered on: 13/10/2022] Trial Registered Prospectively |
| Last Modified On: |
14/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of effect of adavanced and leukocyte platelet rich Fibrin on healing of extraction socket of single rooted teeth |
|
Scientific Title of Study
|
Comparison of the effect of advanced platelet -Rich Fibrin and
Leukocyte- Platelet -Rich Fibrin on healing of extraction socket of single rooted teeth- A Randomized controlled trial.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rutuja Deshmukh |
| Designation |
PG student |
| Affiliation |
VSPM dental college and research center |
| Address |
Department of oral and maxillofacial surgery VSPM Dental college and research centre
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9561457819 |
| Fax |
|
| Email |
rutuja.deshmukh1908@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vrinda Kolte |
| Designation |
Professor |
| Affiliation |
VSPM dental college and research center |
| Address |
Department of oral and maxillofacial surgery VSPM Dental college and research centre
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9822366938 |
| Fax |
|
| Email |
drvrindkolte@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vrinda Kolte |
| Designation |
Professor |
| Affiliation |
VSPM dental college and research center |
| Address |
Department of oral and maxillofacial surgery VSPM Dental college and research centre
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9822366938 |
| Fax |
|
| Email |
drvrindkolte@gmail.com |
|
|
Source of Monetary or Material Support
|
| VSPM dental college and research center,Nagpur |
|
|
Primary Sponsor
|
| Name |
Dr Rutuja Deshmukh |
| Address |
Department of oral and maxillofacial surgery VSPM Dental college and research centre |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rutuja Deshmukh |
VSPM dental college and research centre Nagpur |
Digdoh Hills , Hingna road, Nagpur, department of oral and maxillofacial surgery, OPD no 02
Nagpur
MAHARASHTRA |
8329353714
rutuja.deshmukh1908@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee of VSPM Dental College and Research Centre Nagpur |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A-PRF |
Radiologic examination of each patient will be performed and all will be treated by the same surgeon and assistant. Extraction will be performed using nerve blocking agents -lignocaine with adrenaline (1:2,00,000) locally by giving required blocks for extraction. The tooth will be loosened with elevator and extracted by using suitable forceps. After removal of the tooth, the A‑PRF will be placed into the socket. In all cases, a sterile physiological saline solution containing no antibacterial agent will be used to clean the socket left from the extraction; then, A‑PRF or L‑PRF will be placed inside the tooth socket followed by closing the wound with 3‑0 silk suture. A gauze pad will be placed in the surgical area and the patient will be asked to bite on for 30 min. Stitches will be removed after 7 day |
| Comparator Agent |
L-PRF |
Radiologic examination of each patient will be performed and all will be treated by the same surgeon and assistant. Extraction will be performed using nerve blocking agents -lignocaine with adrenaline (1:2,00,000) locally by giving required blocks for extraction. The tooth will be loosened with elevator and extracted by using suitable forceps. After removal of the tooth, the A‑PRF or L‑PRF will be placed into the socket. In all cases, a sterile physiological saline solution containing no antibacterial agent will be used to clean the socket left from the extraction; then, A‑PRF or L‑PRF will be placed inside the tooth socket followed by closing the wound with 3‑0 silk suture. A gauze pad will be placed in the surgical area and the patient will be asked to bite on for 30 min. Stitches will be removed after 7 day |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient requiring bilateral extraction of single rooted teeth.
2)Patient’s age: 15-40
3)Systemically healthy patients
4)Co-operative, motivated and hygiene conscious patients.
|
|
| ExclusionCriteria |
| Details |
1) Patients with history of systemic diseases, allergies or drug usage.
2) Individual had a prior use of non-steroidal anti-inflammatory drugs or antimicrobial drugs in the last 3 months.
3) Pregnant or lactating women.
4) Patient who has undergone periodontal treatment in last 6 months.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
healing of extraction socket
|
1 day,3days,7days and 3 and 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| bone density |
3 and 6 months |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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
|
N/A |
|
Date of First Enrollment (India)
|
19/10/2022 |
| 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="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
The study will comprise of 20 patients visiting to the Department of Oral and Maxillofacial Surgery, requiring bilateral extraction of single rooted teeth, as per inclusion criteria. Sides will be assigned randomly for placement of A-PRF and L-PRF and operator blinding will be done. Radiologic examination of each patient will be performed and all will be treated by the same surgeon and assistant. Extraction will be performed using nerve blocking agents -lignocaine with adrenaline (1:2,00,000) locally by giving required blocks for extraction. The tooth will be loosened with elevator and extracted by using suitable forceps. After removal of the tooth, the A�’PRF or L�’PRF will be placed into the socket. In all cases, a sterile physiological saline solution containing no antibacterial agent will be used to clean the socket left from the extraction; then, A�’PRF or L�’PRF will be placed inside the tooth socket followed by closing the wound with 3�’0 silk suture. A gauze pad will be placed in the surgical area and the patient will be asked to bite on for 30 min. Stitches will be removed after 7 days. Post-surgical care: Patient will be placed on antibiotics and analgesics. Clinical parameters will be evaluated after 1 day,3days,7days and 3 and 6 months . |