| CTRI Number |
CTRI/2025/06/089746 [Registered on: 27/06/2025] Trial Registered Prospectively |
| Last Modified On: |
24/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on Using a Special Homemade Bone Mix to Treat Tooth and Gum Issues
|
|
Scientific Title of Study
|
Evaluation of indigenously prepared sticky bone in the management of endo- perio lesions: A clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Agrawal Simran Sandeep |
| Designation |
Post Graduate |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Room no. 602 ,Floor no 6, Department of Periodontics,Maulana Azad Institute of Dental Sciences, Mirdard Marg, Bahadur Shah Zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
7721811542 |
| Fax |
|
| Email |
simranagrawal2106@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Arundeep Kaur Lamba |
| Designation |
Senior Professor |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Room no. 602, Floor no 6, Department of Periodontics, Maulana Azad Institute of Dental Sciences, Mirdard Marg, Bahadur Shah Zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
9654700980 |
| Fax |
|
| Email |
arundeep.kaur.lamba@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Agrawal Simran Sandeep |
| Designation |
Post Graduate |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Room no. 602, Floor no 6, Department of Periodontics, Maulana Azad Institute of Dental Sciences, Mirdard Marg, Bahadur Shah Zafar Marg, New Delhi
DELHI
110002
India |
| Phone |
7721811542 |
| Fax |
|
| Email |
simranagrawal2106@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthopaedics, Lok Nayak Hospital, Jawaharlal Nehru Marg, Near Delhi Gate, New Delhi 110002
New Delhi |
|
|
Primary Sponsor
|
| Name |
Agrawal Simran Sandeep |
| Address |
Room no. 602, Floor no 6, Department of Periodontics, Maulana Azad Institute of Dental Sciences, Mirdard Marg, Bahadur Shah Zafar Marg, New Delhi 110002 |
| Type of Sponsor |
Other [Government dental 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 Agrawal Simran Sandeep |
Maulana Azad Institute of Dental Sciences |
Room no. 602, Floor no 6, Department of Periodontics, Mirdard Marg, Bahadur Shah Zafar Marg, New Delhi 110002
Central
DELHI |
7721811542
simranagrawal2106@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects having endo- perio lesion in one or more teeth |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Sticky bone with concentrated growth factor |
Sticky bone with concentrated growth factor is a special material used in dental surgeries to help regrow bone, particularly for patients who have lost bone around their teeth. This material is created by mixing tiny bone particles—often from a donor or made synthetically—with a gel-like substance called concentrated growth factor (CGF), which is made from the patient’s own blood and packed with healing proteins and growth factors. When this mixture is prepared, it becomes sticky and easy to shape, allowing dentists to place it precisely where new bone is needed. Once in place, sticky bone not only keeps the bone particles together but also releases growth factors that speed up the healing and regeneration of bone. This helps patients recover faster, supports the success of future dental implants, and reduces the need for additional surgical materials. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects of either sex between the age group 18 to 55 years who are willing to sign written consent for the study.
2. Subjects having atleast one tooth having periodontal pocket greater than 6mm and periapical involvement.
3. Subjects having persisting periodontal pocket post 3 month of endodontic treatment.
4. Subjects having radiographic evidence of vertical bone loss greater than 4 mm |
|
| ExclusionCriteria |
| Details |
1.Teeth with root caries .
2.History of surgery in the respective tooth in the last 6 months.
3.Uncontrolled systemic diseases (e.g. uncontrolled diabetes, uncontrolled hypertension ,
bleeding disorders).
4.Pregnant or lactating woman.
5.Smokers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in probing depth in the defect site. Changes in clinical attachment level in the defect site. Changes in the bone fill. |
At baseline, 1 month, 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the clinical adverse effects of the grafts, if any. |
At baseline, 1 month, 6 month |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/07/2025 |
| 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 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
|
To evaluate the clinical outcome of sticky bone autologous concentrated growth factor enriched indigenously prepared bone graft matrix for the management of endo-perio lesions. The use of an osseograft combined with CGF has numerous advantages owing to the formation of sticky bone. The product thus formed can be molded, prevent both macro and micro movements, also the network is proven to contain platelets and growth factors thereby contributing to accelerated soft tissue healing and bone regeneration. Furthermore, the fibrin interconnection prevents the ingrowth of soft tissue into the bone graft as well. A thorough search of the literature disclosed the absence of any publication with reference to the use of sticky bone in endodontic surgical procedures, thus highlighting the uniqueness of this study in that regard
|