| CTRI Number |
CTRI/2019/07/020175 [Registered on: 15/07/2019] Trial Registered Prospectively |
| Last Modified On: |
11/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening
Dentistry
Other (Specify) [A-PRF] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
EFFECT OF ADVANCED PLATELET RICH FIBRIN (A-PRF) IN THE TREATMENT OF PERIODONTAL INTRABONY DEFECTS
|
|
Scientific Title of Study
|
EFFECT OF ADVANCED PLATELET RICH FIBRIN (A-PRF) IN THE TREATMENT OF PERIODONTAL INTRABONY DEFECTS : A CLINICAL AND CONE BEAM COMPUTED TOMOGRAPHY STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Md Naseem ashraf |
| Designation |
PG student |
| Affiliation |
sharda university |
| Address |
Department of periodontology
school of dental science
sharda university
Gr. Noida
knowledge park 2
graeter noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9891242043 |
| Fax |
|
| Email |
naseembds@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr shailesh varshney |
| Designation |
Reader |
| Affiliation |
sharda university |
| Address |
Department of periodontology
school of dental science
sharda university
Gr. Noida
knowledge park 2
graeter noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9891242043 |
| Fax |
|
| Email |
shailesh.varshney@sharda.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Md Naseem ashraf |
| Designation |
PG student |
| Affiliation |
sharda university |
| Address |
Department of periodontology
school of dental science
sharda university
Gr. Noida
knowledge park 2
graeter noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9891242043 |
| Fax |
|
| Email |
naseembds@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of periodontology school of dental sciences - sharda university Gr.noida g.b.nagar u.p |
|
|
Primary Sponsor
|
| Name |
Dr Md Naseem Ashraf |
| Address |
school of dental sciences,sharda university,gr.noida u.p |
| Type of Sponsor |
Private 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 md naseem ashraf |
school of dental sciences |
Department of periodontology room no 7 ,sharda university ,knowledge park 3 , gr. noida 201306
Gautam Buddha Nagar
UTTAR PRADESH |
9891242043
naseembds@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
periodontal intrabony defect |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A- prf |
20 mL blood will be drawn from antecubital vein into two 10 mL Vacutainers which will be centrifuged at 1300 revolutions per minute (rpm) for 8 minutes.
• Centrifugation of blood allows the composition of structured fibrin clot (A-PRF) in the middle of the tube, just between the red blood corpuscles at the bottom and acellular plasma at the top.
• From this centrifuged blood the fibrin clots will be separated from red blood corpuscles base (preserving a small red blood cell layer) using sterile tweezer and scissors.
• Thereafter one part of it will be cut into small pieces to be packed as graft into the intrabony defect and the other part will be formed into a membrane.
• This A- PRF membrane will be placed over the intrabony defect to cover the packed A-PRF graft followed by repositioning of mucoperiosteal flap in place using 3-0 nonabsorbable black silk surgical suture. Interrupted or sling sutures will be placed.
• Surgical area will be protected and covered with periodontal dressing (COE-Pack).
• Suitable antibiotics and analgesics (500 mg amoxicillin 3 times per day for 5 days and 400 mg, Paracetamol (650 mg) 3 times a day for 5 days) will be prescribed, along with chlorhexidine digluconate rinses (0.12%) twice daily for 2 weeks.
|
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient with Localized or Generalized Periodontitis with at least one intrabony defect ≥ 3 mm on an IOPA, with probing depth (PD) ≥ 5 mm after scaling and root planning(SRP)
Patient ≥ 18 years either male or female
The base of the defect ≥ 2 mm coronal to the root apex
|
|
| ExclusionCriteria |
| Details |
Patients with immuno-compromised conditions.
Patients on medications that interfere with wound healing.
Patients with Inadequate platelet count ( <200,000/mm3 )
Patients who are Pregnant or lactating.
Patients using tobacco in any form
Teeth with furcation involvement.
A patient who is not willing to give written consent.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate clinically and radiographically the effectiveness of Advanced Platelet-Rich Fibrin
(A-PRF) and open flap debridement (OFD) for the treatment of Intrabony defects using Cone
Beam Computed Tomography |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate clinically and radiographically the effectiveness of Advanced Platelet-Rich Fibrin
(A-PRF) and open flap debridement (OFD) for the treatment of Intrabony defects using Cone
Beam Computed Tomography |
18 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
16/07/2019 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Ø To evaluate clinically and radiographically the effectiveness of Advanced Platelet-Rich Fibrin (A-PRF) and open flap debridement (OFD) for the treatment of Intrabony defects using Cone Beam Computed Tomography. |