| CTRI Number |
CTRI/2021/04/032877 [Registered on: 16/04/2021] Trial Registered Prospectively |
| Last Modified On: |
18/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical and radiological evaluation of xenograft alone and in combination with concentrated growth factor in regenration of infrabony periodontal defects |
|
Scientific Title of Study
|
Comparitive evaluation of effect of Demineralized bone matrix( DMBM) Xenograft with or without concentrated Growth Factor (CGF) in infrabony defect- A Randomised Controlled Clinical 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 Tajinder Pal Singh Sandhu |
| Designation |
PG Student |
| Affiliation |
J.N.Kapoor D.A.V (c) Dental College |
| Address |
Dept. of Periodontology and Oral Implantology.
J.N.Kapoor D.A.V c Dental College, Yamuna Nagar
Dept. of Periodontology and Oral Implantology.
J.N.Kapoor D.A.V c Dental College, Yamuna Nagar
Yamunanagar
HARYANA
135001
India |
| Phone |
9468295517 |
| Fax |
|
| Email |
tsandhu234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepika Bali |
| Designation |
Associate Prof. |
| Affiliation |
J.N.Kapoor D.A.V (c) Dental College |
| Address |
Dept. of Periodontology and Oral Implantology.
J.N.Kapoor D.A.V c Dental College, Yamuna Nagar
Dept. of Periodontology and Oral Implantology.
J.N.Kapoor D.A.V c Dental College, Yamuna Nagar
Yamunanagar
HARYANA
135001
India |
| Phone |
9466302335 |
| Fax |
|
| Email |
drdeepikab17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tajinder Pal Singh Sandhu |
| Designation |
PG Student |
| Affiliation |
J.N.Kapoor D.A.V (c) Dental College |
| Address |
Dept. of Periodontology and Oral Implantology.
J.N.Kapoor D.A.V c Dental College, Yamuna Nagar
Dept. of Periodontology and Oral Implantology.
J.N.Kapoor D.A.V c Dental College, Yamuna Nagar
Yamunanagar
HARYANA
135001
India |
| Phone |
9468295517 |
| Fax |
|
| Email |
tsandhu234@gmail.com |
|
|
Source of Monetary or Material Support
|
| Deptt. of Periodontology and Oral Implantology |
|
|
Primary Sponsor
|
| Name |
JNKapoor DAV c Dental College |
| Address |
Yamuna Nagar, Haryana, -135001 |
| Type of Sponsor |
Private medical college |
|
|
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 Tajinder Pal Singh Sandhu |
J.N.Kapoor D.A.V c Dental College |
Dept. of Periodontology and Oral Implantology.
Yamunanagar
HARYANA |
9468295517
tsandhu234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee of J.N.Kapoor D.A.V Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Periodontitis with infrabony defects in teeth. |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Xenograft alone |
Xenograft (DMBM) alone.
One hour procedure and results evaluated at 3 and 6 months intervals. |
| Intervention |
Xenogrft and Concentrated Growth Factor
Xenograft |
Concentrated Growth Factor (CGF)- Platelet Rich Fibrin
Xenograft (DMBM).
One hour procedure and results evaluated at 3 and 6 months intervals. |
|
|
Inclusion Criteria
|
| Age From |
24.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
periodontal probing depth equal to or more than 5mm.
radiographic infrabony bone loss equal to or more than 3 mm. |
|
| ExclusionCriteria |
| Details |
Known systemic disease and conditions.
Currently consuming any form of tobacoo.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Defect depth.
Amount of defect fill.
Percent of defect fil.
Amount of defect resolution.
Percent of defect resolution. |
Baseline, 3 Months, 6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pocket Depth
Plaque Index
Clinical Attachment Level.
Bleeding Index |
Baseline, 3 Months, 6 Months |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="11" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/04/2021 |
| Date of Study Completion (India) |
16/10/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Study will compare the efficacy of concentrated growth factor in combination with xenograft for the treatment of infrabony defects in the patients having periodontitis. Evaluation will be assessed both clinically and radiographically and will be compared with the xenograft alone group. |