| CTRI Number |
CTRI/2023/06/053875 [Registered on: 14/06/2023] Trial Registered Prospectively |
| Last Modified On: |
13/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Hyaluronic Acid with PRF and PRF alone in the management of intrabony defects with the help of cone beam computed tomography
|
|
Scientific Title of Study
|
Evaluation of Hyaluronic Acid in combination with PRF and PRF alone assessed by cone beam computed tomography in the management of intrabony defects: 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 SAEEKA DESHMUKH |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SWARGIYA DADASAHEB KALMEGH SMRUTI DENTAL COLLEGE AND HOSPITAL |
| Address |
FIRST FLOOR,5,DEPARTMENT OF PERIODONTOLOGY AND IMPLANTOLOGY, SWARIGYA DADASAHEB KALMEGH SMRUTI DENTAL COLLEGE AND HOSPITAL HINGNA,NAGPUR.
MAHARASHTRA
441110
INDIA
Nagpur
MAHARASHTRA
444607
India |
| Phone |
8275138083 |
| Fax |
|
| Email |
skdeshmukh0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SALMAN ANSARI |
| Designation |
HEAD OF DEPARTMENT |
| Affiliation |
SWARGIYA DADASAHEB KALMEGH SMRUTI DENTAL COLLEGE AND HOSPITAL |
| Address |
FIRST FLOOR,5,DEPARTMENT OF PERIODONTOLOGY, SWARGIYA DADASAHEB SMRUTI DENTAL COLLEGE AND HOSPITAL HINGNA,NAGPUR
MAHARASHTRA
441110
INDIA
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9665063023 |
| Fax |
|
| Email |
salman.ansari@sdk-dentalcollege.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DR SALMAN ANSARI |
| Designation |
HEAD OF DEPARTMENT |
| Affiliation |
SWARGIYA DADASAHEB KALMEGH SMRUTI DENTAL COLLEGE AND HOSPITAL |
| Address |
FIRST FLOOR,5,DEPARTMENT OF PERIODONTOLOGY,SWARGIYA DADASAHEB KALMEGH SMRUTI DENTAL COLLEGE AND HOSPITAL HINGNA, NAGPUR.
MAHARASHTRA
441110
INDIA
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9665063023 |
| Fax |
|
| Email |
salman.ansari@sdk-dentalcollege.edu.in |
|
|
Source of Monetary or Material Support
|
| HYALURONIC ACID(GINGEGEL) FROM RICERFERMA COMPANY ITALY |
|
|
Primary Sponsor
|
| Name |
Swargiya Dadasaheb Kalmegh Smruti Dental College and hospital |
| Address |
waddhamna wanadongri hingna road nagpur 441110 |
| 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 |
| dr saeeka deshmukh |
Swargiya Dadasaheb Kalmegh Smruti Dental College and hospital |
First Floor Block no 5,Department of Periodontology,Waddhamna Wanadongri Hingna Road
Nagpur
MAHARASHTRA |
9307694719
skdeshmukh0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
chronic periodontitis |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
hyaluronic acid and prf |
The patients will be given 2% Lignocaine Injection with adrenaline. Patients allocated to group I that is control group, having intrabony defects will be treated with platelet rich fibrin with open flap debridement and group II that is the test group, will be treated with Hyaluronic Acid in combination with PRF with open flap debridement following all sterilization and disinfection protocols
Conventional Approach consisting of periodontal access flap will be initiated by intracrevicular incision using Bard- Parker number 11 or 15 surgical blades on the buccal and lingual aspects. A tooth each distal and mesial to the defect associated tooth will be included in the flap. Full thickness flap (mucoperiosteal flap) will be reflected using periosteal elevator to expose alveolar bone in area of osseous defect. The osseous defect will be debrided off granulation tissue using hand instruments followed by ultrasonic instruments.
After this Hyaluronic Acid will be mixed with PRF and this will be inserted into the defect. The flap will be sutured using 3-0 vicryl or silk suture. Periodontal pack (coe pack) will be placed on the lingual and buccal aspect.
|
| Comparator Agent |
prf |
The surgical procedure for the control site will be identical to the procedure of test site except the placement of Hyaluronic Acid.
PLATELET RICH FIBRIN PREPERATION PROTOCOLS
 10ml of venous blood samples will be collected from patients arm by syringe and immediately transferred to the glass tube.
 In centrifugation machine the tubes will be centrifuged at 3300 rpm for 12minutes.
 After centrifugation, by using sterile tweezers the PRF clots will be separately removed from the red corpuscles base and placed in a PRF box.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy patients.
Patients with mild to moderate chronic periodontitis with 2 & 3 walled intrabony defects.
Full mouth plaque scores should be less than 15%.
|
|
| ExclusionCriteria |
| Details |
Patients who underwent flap surgery within 1year.
Teeth indicated for extraction.
Patients having habit of consuming tobacco in any form.
Patients having any systemic or local immunodeficiency.
Pregnant and lactating women.
Patients on any drug therapy which may affect the outcome of present study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluation of efficacy of Hyaluronic Acid in combination with PRF in intrabony defects clinically by measuring probing depth, relative attachment loss, plaque index and gingival index.
2)To evaluate the radiographic defect fill with the use of Hyaluronic Acid
in combination with PRF and PRF alone in intrabony defects
by measuring defect depth, mesio-lingual defect width and bucco-lingual defect width. |
baseline and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluating the efficacy of Hyaluronic Acid in combination with PRF and PRF alone in intrabony defects, clinically by measuring clinical attachment loss, relative attachment loss, plaque index and gingival index and radiographically by measuring defect depth, mesio-lingual defect depth and bucco-lingual defect depth |
baseline and 6 months |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
23/06/2023 |
| 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="7"
Days="5" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
yet to be completed |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Periodontitis is an infectious disease that causes destruction of the toothattachment apparatus. If periodontitis is left untreated it may result in
progressive attachment loss that may eventually lead to early tooth
loss.
1
The soft and hard tissue loss occurred as a result of periodontitis, cannot
be managed successfully by nonsurgical therapy alone and requires
modalities for the regeneration of lost tissues.
In halting the progression of periodontitis and maintaining disease related
defects conventional periodontal treatments such as scaling, root
planning and open flap debridement are highly effective.2
For osseous, furcation and recession defects periodontal regenerative
procedures are included such as soft tissue grafts, bone replacement
grafts, root biomodifications, guided tissue regeneration, and
combinations thereof.
3
Advances in understanding the inflammatory mechanisms and wound
healing processes associated with periodontal diseases have led
researchers to study the potential of numerous extracellular matrix
components as promoters of periodontal healing and regeneration.
4
Hyaluronic Acid (HA) is one such natural extracellular matrix component,
which plays a vital role in the functioning of extracellular matrices,
including those of the periodontium. HA significantly increases the tensile
strength of granulation tissue, initiates angiogenesis, stimulates clot
formation, and augments bone formation.
4
Through increased mesenchymal cell differentiation and migration
Hyaluronic Acid augments osteoblastic bone formation. In the
morphologically healing of bone wounds HA provides the potential means
for accelerating new bone formation.5
There are several growth factors that are used in order for bone healing
and bone regeneration. PRF(PLATELET RICH FIBRIN) is an autologous fibrin with abundance of
platelets and leukocyte cytokines. PRF contains proportionately high
levels of growth factors, including the platelet-derived growth factor
(PDGF), TGF, vascular endothelial growth factor, insulin-like growth factor
(IGF), and epidermal growth factor (EGF).
In bone grafting or bone defect healing, the growth factors play a central
role in bone regeneration process and in hemostasis which makes PRF
more advantageous.
6
Cone beam computed tomography (CBCT) provides a 3-dimensional
(3D) view of the maxillofacial complex. Visualization of periodontal bone
defects in 3 dimensions can be valuable because it has been shown that
the healing of these defects is highly dependent on defect anatomy. .
Therefore, the outcome of the treatment is predicted on an accurate
examination of the defect’s anatomy.
7
To the best of our knowledge no studies have been carried out comparing
the use of combination of Hyaluronic Acid + PRF and PRF alone in
intrabony defects. |