| CTRI Number |
CTRI/2026/01/101553 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of intraosseous Vertical periodontal defect using NOVO graft as a bone regenerative material in patients having chronic generalized periodontitis with periodontal pockets of more than or equals to 5 mm |
|
Scientific Title of Study
|
To evaluate the efficacy of NOVO graft as a bone regenerative material in the treatment of intraosseous periodontal defects: A clinical and CBCT analysis |
| 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 Shalini Mishra |
| Designation |
PG Student |
| Affiliation |
Hitkarini Dental College and Hospital |
| Address |
222 KH
Village Adarsh Gram Seoni
tehsil Jaithari near Indane gas agency Anuppur Madhya Pradesh
PINCODE 484330
222 KH
Village Adarsh Gram Seoni
tehsil Jaithari near Indane gas agency District Anuppur Madhya Pradesh
Shahdol
MADHYA PRADESH
484330
India |
| Phone |
9109071637 |
| Fax |
|
| Email |
shalinirsmishra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Elashri Chatterjee |
| Designation |
Professor |
| Affiliation |
Hitkarini Dental College and Hospital |
| Address |
Room number 6
Staff quarters
Hitkarini Dental College and Hospital
Hitkarini Hills Dumna Jabalpur
Madhya Pradesh
Jabalpur
MADHYA PRADESH
482005
India |
| Phone |
7000395785 |
| Fax |
|
| Email |
elashree03@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shalini Mishra |
| Designation |
PG Student |
| Affiliation |
Hitkarini Dental College and Hospital |
| Address |
222 KH
Village Adarsh Gram Seoni
tehsil Jaithari near Indane gas agency Anuppur Madhya Pradesh
222 KH
Village Adarsh Gram Seoni
tehsil Jaithari near Indane gas agency Anuppur Madhya Pradesh
Shahdol
MADHYA PRADESH
484330
India |
| Phone |
9109071637 |
| Fax |
|
| Email |
shalinirsmishra@gmail.com |
|
|
Source of Monetary or Material Support
|
| NOVO Tissue Bank and Research Centre |
|
|
Primary Sponsor
|
| Name |
Novo Tissue Bank and Research Centre |
| Address |
Anita Apartment Shivaji Nagar Road Vakola Santacruz(E) Mumbai
400055 |
| Type of Sponsor |
Other [Tissue Bank and Research Centre] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Hitkarini Dental College And Hospital |
Hitkarini Dental College and Hospital
Hitkarini hills Dumna
Jabalpur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shalini Mishra |
Hitkarini Dental College and Hospital |
Ground Floor
Room no 2
Hitkarini Dental College and Hospital
Hitkarini Hills Dumna Jabalpur
Jabalpur
MADHYA PRADESH |
09109071637
shalinirsmishra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hitkarini Dental College and Hospital, Jabalpur Institutional Ethical Committee (HDCH-IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NOVO Graft |
open flap debridement with placement of NOVO GRAFT in intra osseous periodontal defects |
| Comparator Agent |
Without NOVO Graft |
open flap debridement alone in intraosseous periodontal defects |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
(1)Patients diagnosed as having chronic generalized periodontitis with periodontal pockets of more than or equal to 5 mm with radiographic evidence of vertical bone loss (2 walled and 3 walled defects)
(2)Age group between 30 to 55 years
(3)Patients with good general health without any history of systemic disease or medication. |
|
| ExclusionCriteria |
| Details |
(1)Patients showing unacceptable oral hygiene during pre surgical (Phase I) period
(2)Smokers
(3)pregnant women and lactating mothers |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in the amount of bone fill in the periodontal 2 walled and 3 walled intraosseous defects |
Baseline, 3 months, 6 months, 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in probing pocket depth and increase in relative attachment level before and after treatment |
Baseline, 3 months, 6 months, 9 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
27/01/2026 |
| 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 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
|
This randomized controlled clinical trial aims to evaluate the effectiveness of NOVO GRAFT, a demineralized freeze-dried bone allograft, in treating intraosseous periodontal defects. Thirty defect sites will be divided into a control group (open flap debridement alone) and an experimental group (open flap debridement with NOVO GRAFT). Clinical parameters such as probing pocket depth, relative attachment level, plaque index, and gingival index, along with radiographic bone fill assessed by CBCT, will be recorded at baseline and up to nine months. The study seeks to determine whether NOVO GRAFT enhances periodontal regeneration compared to conventional therapy. |