| CTRI Number |
CTRI/2019/05/019461 [Registered on: 31/05/2019] Trial Registered Prospectively |
| Last Modified On: |
27/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of concentrated growth factor and platelet rich fibrin for Treatment of human periodontal defects |
|
Scientific Title of Study
|
A Comparative Evaluation of Effectiveness of Concentrated Growth Factor (CGF) and Platelet rich fibrin (PRF) alone in the Treatment of Human Infrabony Defects– A Clinical and Radiographic 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 Ruchika Lulla |
| Designation |
PG student |
| Affiliation |
Datta Meghe Institute of Medical Sciences |
| Address |
Dept. Of Periodontics
Sharad Pawar Dental College and Hospital
Sharad Pawar Dental College
Dept. of Periodontics
Sawangi (M)
Wardha
MAHARASHTRA
442001
India |
| Phone |
7588752199 |
| Fax |
|
| Email |
ruchika.lulla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Jaiswal |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Medical Sciences |
| Address |
Sharad Pawar Dental College
Dept. Of Periodontics
Sharad Pawar Dental College
sawangi (m)
Wardha
MAHARASHTRA
442004
India |
| Phone |
9960713010 |
| Fax |
|
| Email |
priyanka.banode@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Jaiswal |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Medical Sciences |
| Address |
Sharad Pawar Dental College
Dept. Of Periodontics
Sharad Pawar Dental College
sawangi (m)
MAHARASHTRA
442004
India |
| Phone |
9960713010 |
| Fax |
|
| Email |
priyanka.banode@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sharad Pawar Dental College
Sawangi (M), Wardha |
|
|
Primary Sponsor
|
| Name |
not applicable |
| Address |
not applicable |
| Type of Sponsor |
Other [not applicable] |
|
|
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 Ruchika Lulla |
Sharad Pawar Dental College |
Room no. 3
Dept. of Periodontics
PG section
Wardha
MAHARASHTRA |
7588752199
ruchika.lulla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Datta Meghe Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Platelet rich fibrin |
A standard protocol will be follow for preparing platelet rich fibrin (PRF). Prior to the surgery, about 5ml intravenous blood will be drawn and collected in sterile tubes (without addition of anticoagulant) and centrifuged at 3000 rpm for 10 minutes. This allows formation of structured fibrin clot in the centre of the test tube. Sterile tweezers and scissors will be used to separate the PRF from red corpuscular base. It will then be compressed to squeeze out the serum and obtain a fibrin membrane. |
| Intervention |
Concentrated Growth Factor |
CGF is an advanced second generation platelet concentrate, obtained with differential continuous centrifugal technology, containing many kinds of growth factors and fibrins, and able to facilitate the recovery of soft and hard tissues. CGFs will be produced as follow: 9 ml of blood will be drawn in sterile tubes without anticoagulant solutions. These tubes will be then immediately centrifuged using a program with the following characteristics: 30 s acceleration, 2 min at 2700 rpm, 4 min at 2400 rpm, 4 min at 2700 rpm, 3 min at 3000 rpm and 36 s deceleration and stop. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Presence of at least 1 or 2 radiographically detectable interproximal intrabony osseous defect with probing pocket depth ≥ 5 mm and clinical attachment loss ≥ 5 mm following initial therapy.
2. Depth of intraosseous component of the defect ≥ 3 mm by clinical and radiographic means, which will be confirmed on intrasurgical measurment
3. A radiographic base of the defect at least 3 mm coronal to the apex of the tooth.
4. Presence of at least 3 mm width of keratinized gingiva around test teeth to allow complete soft tissue coverage of the defect.
|
|
| ExclusionCriteria |
| Details |
1. Evidence of localized aggressive periodontitis.
2. Patients with unacceptable oral hygiene (Plaque Index >1)
3. Smokers (recent history of smoking more than 10 cigarettes /day) or who used any of tobacco products.
4. Study tooth with inadequate endodontic / restorative treatments.
5. Study tooth with mobility exceeding grade II and exhibiting a class III or class IV furcation defect.
6. History of periodontal surgical therapy of the selected quadrant.
7. Pregnant females or lactating mothers.
8. Clinical or radiographic signs of untreated acute infection at the selected site, apical pathology, root fracture, severe root irregularities, cemental pearls, cementoenamel projections not easily removed by odontoplasty, untreated carious lesions at cementoenamel junction (CEJ) or on the root surface.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Probing Pocket Depth
Clinical Attachment Level |
baseline, 3 months, 6 months, 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Periodontal health |
baseline, 3 months, 6 months, 9 months |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
31/05/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Various graft materials have been successfully
used in the treatment of intrabony defects. The materials most commonly used
have been autografts and allografts. Growth factors are bioactive proteins
which regulate a variety of cellular processes. Concentrated Growth Factors
(CGF) was first developed by Sacco (2006), is a relatively new technology
within the area of regenerative medicine. CGF is an advanced second generation
platelet concentrate, obtained with differential continuous centrifugal
technology, containing many kinds of growth factors and fibrins, and able to
facilitate the recovery of soft and hard tissues. CGF is different from
platelet-rich plasma (PRP) and platelet-rich fibrin (PRF) in the methods for
production because no additives are added during its production. CGF has a
higher adhesive strength, tensile strength, higher viscosity than the other
platelet preparations. CGF has a difference in centrifugation speed which
permits the isolation of much larger and denser fibrin matrix richer in growth
factors. CGF is a fibrin rich organic matrix which contains growth factors,
platelets, leukocytes and CD34+ stem cells which help in the process of
regeneration and also has immunological cells that are effective in regulating
inflammation and minimizing the risk of infection. (CGF) is a biological
inducing material which improves the quality of the formed bone, and
facilitates the formation of bones and the healing of tissues. Therefore, the present study will be undertaken to evaluate the
effectiveness of Concentrated growth factor and PRF alone for the treatment of
infrabony defects in humans |