| CTRI Number |
CTRI/2024/06/069603 [Registered on: 27/06/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of effect of Autologous Sticky Bone,PRF and Octacalcium Phosphate coated Deproteinized Bovine bone material for the treatment in patients with periodontal vertical bone defects. |
|
Scientific Title of Study
|
Comparative Evaluation of the Effectiveness of Autologous Sticky Bone with that of Autologous PRF and Octacalcium Phosphate-Coated Deproteinized Bovine Bone Graft Material in the Regeneratin of Human Periodontal Infrabony Defects- A Randomised Control Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sakshi Kotecha |
| Designation |
Postgraduate Student |
| Affiliation |
Sharad Pawar Dental College |
| Address |
Department of Periodontics and Implantology, Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research,Sawangi, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9075340044 |
| Fax |
|
| Email |
drsakshikotecha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Priyanka Jaiswal |
| Designation |
Professor |
| Affiliation |
Sharad Pawar Dental College |
| Address |
Department of Periodontics and Implantology, Sharad Pawar Dental College,Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha.
Wardha
MAHARASHTRA
442001
India |
| Phone |
9960713010 |
| Fax |
|
| Email |
priyanka.banode@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sakshi Kotecha |
| Designation |
Postgraduate Student |
| Affiliation |
Sharad Pawar Dental College |
| Address |
Department of Periodontics and Implantology, Sharad Pawar Dental College,Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9075340044 |
| Fax |
|
| Email |
drsakshikotecha@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sharad Pawar Dental College |
| Address |
Sharad Pawar Dental College, Datta Meghe Institue of Higher Education and Research (DMIHER(DU)), Sawangi, Wardha-442001 |
| 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 Sakshi Kotecha |
Sharad Pawar Dental College |
Department of Periodontics and Implantology, Sharad Pawar Dental College, Sawangi, Wardha
Wardha
MAHARASHTRA |
9075340044
drsakshikotecha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Autologous PRF and Octacalcium Phosphate-Coated Deproteinized Bovine Bone Graft Material |
Octacalcium Phosphate Coated Deproteinized Bovine Bone Material(Ti-Oss Bone graft) covered with Autologous PRF membrane will be placed into the osseous defect in control site with light pressure till it is filled up to the most coronal level of osseous wall by raising the flap.The flap will be coronally repositioned and sutured in such a way that the flap margin will be located 1 to 2 mm coronal to CEJ, ensuring primary flap closure. A combination of vertical mattress suture and interproximal sutures will be used to secure the flap in position. |
| Intervention |
Autologous Sticky Bone |
Autologous Sticky Bone will be placed into the osseous defect in test site with light pressure till it is filled up to the most coronal level of osseous wall by raising the flap.The flap will be coronally repositioned and sutured in such a way that the flap margin will be located 1 to 2 mm coronal to CEJ, ensuring primary flap closure. A combination of vertical mattress suture and interproximal sutures will be used to secure the flap in position. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Presence of at least 1 or 2 radiographically detectable interproximal infrabony 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 intra-surgical measurement.
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 |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Radiographic Bone Fill in Infrabony defects at 6 months post surgery. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Gain in Clinical Attachment Level(CAL)
2)Reduction in Probing Pocket Depth |
6 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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Periodontal regeneration is
challenging because it requires the predictable regeneration of three very
distinct and varied tissues (such as cementum, PDL, and bone) as well as a
triphasic contact between them in order to guarantee the repair. The aim of the
current study will be to compare and evaluate the effectiveness of autologous sticky
bone with that of autologous PRF and deproteinized, octacalcium
phosphate-coated bovine bone graft material in the regeneration of human
periodontal infrabony defects using clinical and radiographic data. Twenty
individuals in good systemic health will be treated with autologous sticky
bone (Group-A) and autologous PRF in combination with deproteinized,
octacalcium phosphate-coated bovine bone graft material (Group-B) for twenty
periodontal infrabony defects. Clinical and radiographic features will be evaluated
before surgery and six months following the procedure. The final data will be subjected
to statistical analysis. |