| CTRI Number |
CTRI/2024/05/066810 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative study of Treatment of vertical bone defect around the tooth using two platelet concentrates obtained from patients own blood |
|
Scientific Title of Study
|
“Treatment of Periodontal Intraosseous Defects Using Autologous Injectable Platelet-Rich Fibrin (Sticky Bone) and Titanium Platelet-Rich Fibrin: A Comparative Study†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
P Surya |
| Designation |
Post graduate |
| Affiliation |
Karpaga Vinayaga Institute Of Dental Sciences |
| Address |
ROOM No.7,Third floor,
Department of periodontology,
Karpaga Vinayaga Institute Of Dental Sciences,
GST Road,
Chinna kolambakkam,
Palayanoor (PO),
Chengalpattu (DT)
Madhuranthakam(TK)
Chennai
TAMIL NADU
603308
India |
| Phone |
7708528770 |
| Fax |
|
| Email |
suryaperiomds@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr . Dhivakar C.P |
| Designation |
Professor |
| Affiliation |
Karpaga Vinayaga Institute Of Dental Sciences |
| Address |
No.7, Third floor,
Department of periodontology,
Karpaga Vinayaga Institute Of Dental Sciences
GST Road,
Chinna kolambakkam,
Palayanoor (PO),
Chengalpattu (DT)
Madhuranthakam(TK)
No.7, Third floor,
Department of periodontology,
Karpaga Vinayaga Institute Of Dental Sciences,
GST Road,
Chinna kolambakkam,
Palayanoor (PO),
Chengalpattu (DT)
Madhuranthakam(TK)-603308
Chennai
TAMIL NADU
603308
India |
| Phone |
8056004763 |
| Fax |
|
| Email |
drdhivakarperio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Surya P |
| Designation |
Post graduate |
| Affiliation |
Karpaga Vinayaga Institute Of Dental Sciences |
| Address |
No.7, Third floor,
Department of periodontology,
Karpaga Vinayaga Institute Of Dental Sciences,
GST Road,
Chinna kolambakkam,
Palayanoor (PO),
Chengalpattu (DT)
Madhuranthakam(TK)
GST Road,
Chinna kolambakkam,
Palayanoor (PO),
Chengalpattu (DT)
Madhuranthakam(TK)-603308
Chennai
TAMIL NADU
603308
India |
| Phone |
7708528770 |
| Fax |
|
| Email |
suryaperiomds@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karpaga Vinayaga Institute of Dental Sciences |
|
|
Primary Sponsor
|
| Name |
Karpaga Vinayaga Institute of Dental Sciences |
| Address |
GST road,
chinna kolambakkam,
Palayanoor (PO),
Chengalpattu (DT),
Madhuranthakam (TK)-603308
|
| Type of Sponsor |
Research institution |
|
|
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 Surya P |
Karpaga Vinayaga Institute Of Dental Sciences |
ROOM NO.7,Department of periodontology,Third floor,
Karpaga Vinayaga Institute Of Dental Sciences
GST Road,
Chinna kolambakkam,
Palayanoor (PO),
Chengalpattu (DT)
Madhuranthakam(TK)-603308
Kancheepuram
TAMIL NADU |
7708528770
suryaperiomds@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Karpaga Vinayaga Institute Of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PERIODONTITIS |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injectable platelet rich fibrin as sticky bone |
platelet concentrate mixed with bone graft |
| Intervention |
Open flap debridement |
Open flap debridement with Injectable platelet rich fibrin- sticky bone |
| Intervention |
Open flap debridement |
Open flap debridement with titanium platelet concentrate with bone graft |
| Comparator Agent |
Titanium platelet rich fibrin |
platelet concentrate centrifuged in titanium tubes |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Systemically healthy individuals
2.Periodontitis patients with probing pocket depths
≥ 5mm
3.Patients with intra osseous defects
|
|
| ExclusionCriteria |
| Details |
1.Individuals with any form of systemic illness
2.Patients with parafunctional habits
3.Mobility
4.Smokers
5.Patients with poor plaque control
6.Pregnant and lactating women
7.Those individuals who had undergone recent periodontal treatment within 6 months prior to the study
8.Individuals who were on antibiotics in previous
6 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Regeneration of the intra-osseous defect with platelet concentrates |
At baseline ,3 months ,6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of Clinical Parameters – plaque index, probing pocket depth (PPD), relative attachment level, and defect depth reduction |
At baseline ,3 months ,6 months |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Included patients with intra-osseous defects and divided in to 3 groups open flap debridement with T PRF in one group I PRF with sticky bone in one group and other group with open flap debridement alone. Baseline measurements were recorded and checked after 6 months. |