| CTRI Number |
CTRI/2024/09/073360 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
16/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Sticky Bone and Advanced Platelet-Rich Fibrin for Healing Jaw Bony Defects: A Clinical Study |
|
Scientific Title of Study
|
The Regenerative Potential of Sticky-Bone and Advanced Platelet-Rich Fibrin (A-PRF) with Intra-marrow Penetration in the Management of Intra-bony Defects: A Randomized Clinical Trial |
| Trial Acronym |
IMP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Bendict |
| Designation |
Post Graduate |
| Affiliation |
SREE SAI DENTAL COELLEGE AND RESEARCH INSTITUTE |
| Address |
Department of Periodontology and Oral Implantology, Sree Sai Dental College and Research Institute, Chapuram, Srikakulam 532001
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
8500007916 |
| Fax |
|
| Email |
dr.bendict@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Anil Kumar |
| Designation |
Head of the Department |
| Affiliation |
Sree Sai Dental College and Research Institute |
| Address |
Department of Periodontology and Oral Implantology, Sree Sai Dental College and Research Institute, Chapuram, Srikakulam - 532001
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
9989570600 |
| Fax |
|
| Email |
anilkanc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Bendict |
| Designation |
Post Graduate |
| Affiliation |
Sree Sai Dental College and Research Institute |
| Address |
Department of Periodontology and Oral Implantology, Sree Sai Dental College and Research Institute, Chapuram, Srikakulam - 532001
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
8500007916 |
| Fax |
|
| Email |
dr.bendict@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sree Sai Dental College and Research Institute, Chapuram, Srikakulam,Andhra Pradesh- 532001 India |
|
|
Primary Sponsor
|
| Name |
Dr N Bendict |
| Address |
Department of Periodontology and Oral Impalntology, Sree Sai Dental college and Research Institute, Chapuram, Srikakulam - 532001 |
| Type of Sponsor |
Other [Self] |
|
|
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 N Bendict |
Sree Sai Dental College And Research Institute |
Deparment of Periodontology and Oral Implantology
Srikakulam
ANDHRA PRADESH |
8500007916
dr.bendict@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Helathy Human Volunteers with no Systemic Illness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intramarrow penetration with Advanced platelet rich fibrin (A-PRF) |
Advanced Platelet-Rich Fibrin will be prepared by obtaining 10 ml of blood from the patient by drawing through the antecubital vein and placing in sterilized vacuum evacuated vials without an anticoagulant and centrifuged immediately for 14 min at 1500 rpm. The resultant clots will be compressed in a sterile syringe to obtain a plug.
The operated site of the patient will be anesthetized with 2% local anesthesia with 1:200000 adrenaline. No 15 blade was used to give crevicular incision and full thickness mucoperiosteal flap will be reflected and the debridement will be done to remove granulation tissue. A handpiece will be used to make intra-marrow penetration in the interdental area. The Advanced Platelet-Rich Fibrin (A-PRF) plug is filled inthe defect in another group. The patient is recalled at 6 months after surgery for clinical and radiographic evaluation and the duration of the study is 18 months |
| Intervention |
Intramarrow penetration with Sticky - Bone |
The operated site of the patient will be anesthetized with 2% local anesthesia with 1:200000 adrenaline. No 15 blade was used to give crevicular incision and full thickness mucoperiosteal flap will be reflected and the debridement will be done to remove granulation tissue. A handpiece will be used to make intra-marrow penetration in the interdental area. The required amount of Sticky bone will be taken and the defect is filled in one groupand suturing is done with 3-0 suture. The patient is recalled at 6 months after surgery for clinical and radiographic evaluation. Duration of the study is 18 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy patients.
Presence of intra-bony defect.
Minimum of two teeth with Probing pocket depth ≧ 5mm.
Clinical attachment loss ≧ 4mm.
Depiction of angular defects in the intraoral periapical radiograph
|
|
| ExclusionCriteria |
| Details |
Medically compromised patients
Teeth with grade III mobility, non-vital
Pregnant, and lactating women
Smokers
Patients on medications known to interfere with periodontal tissue health and healing
Previous periodontal surgery on the involved teeth
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Sticky Bone with intra-marrow penetration in the management of intra-bony defects.
To evaluate the efficacy of (A–PRF) with intra-marrow penetration in the management of intra-bony defects. |
At Baseline and 6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Sticky bone & (A-PRF) with intra-marrow penetration in the management of intra-bony defects. |
At Baseline & 6 Months |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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 4 |
|
Date of First Enrollment (India)
|
02/12/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This is a randomized parallel-group study comparing the efficacy of Sticky bone with intra-marrow penetration and Advanced platelet-rich fibrin (A-PRF) with intra-marrow penetration in 25 patients for 6 months. The primary outcome is to assess the regenerative potential of Sticky bone and Advanced platelet-rich fibrin (A-PRF) with intra-marrow penetration in the management of intra-bony defect |