| CTRI Number |
CTRI/2025/03/082435 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Study related to comparing bone graft material along with placental extract gel and without placental extract gel: A randomized clinical trial
|
|
Scientific Title of Study
|
Comparative clinical and radiographic evaluation of efficacy of demineralized freeze-dried bone allograft along with placental extract gel versus demineralized freeze-dried bone allograft alone in treatment of infrabony defects: A Randomized Clinical 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 Jha Sonuanand |
| Designation |
Post graduate student |
| Affiliation |
Government Dental College and Hospital, Jamnagar |
| Address |
112, Department of Periodontology and Implantology, Government Dental College and Hospital, Navagam Ghed, Jamnagar, Gujarat-361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9867467103 |
| Fax |
|
| Email |
jhasonu1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayana Patel |
| Designation |
Dean and Head of Department |
| Affiliation |
Government Dental College and Hospital |
| Address |
112, first floor Department of Periodontology and Implantology, Government Dental College and Hospital, Jamnagar, Gujarat-361008
112, first floor Department of Periodontology and Implantology, Government Dental College and Hospital, Jamnagar, Gujarat-361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9825191911 |
| Fax |
|
| Email |
drnayanagpatel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jha Sonuanand |
| Designation |
Postgraduate Student |
| Affiliation |
112, Department of Periodontology and Implantology, Government Dental College and Hospital, Jamnagar |
| Address |
112, Department of Periodontology and Implantology, Government Dental College and Hospital, Navagam Ghed, Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9867467103 |
| Fax |
|
| Email |
drnayanagpatel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital, Jamnagar
navagam road
pincode-361008
gujarat |
|
|
Primary Sponsor
|
| Name |
Dr Jha Sonuanand |
| Address |
112, Department of Periodontology and Implantology, Government Dental College and Hospital, Navagam Ghed, Jamnagar
Gujarat- 361008 |
| 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 Jha Sonuanand |
Government Dental College and Hospital, Jamnagar |
112, Department of Periodontology and Implantology, Government Dental College and Hospital, Navagam Ghed, Jamnagar
Jamnagar
GUJARAT |
9867467103
jhasonu1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, M.P. SHAH MEDICAL COLLEGE AND GURU GOBINDSINGH HOSPITAL, JAMNAGAR |
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 |
Demineralized freeze dried bone allograft with placebo gel |
After complete debridement of the infrabony defect, Demineralized freeze dried bone allograft mixed with placebo gel will be placed in the defect |
| Intervention |
Demineralized freeze dried bone allograft with placental extract |
After complete debridement of the infrabony defect, Demineralized freeze dried bone allograft mixed with placental extract will be placed in the defect |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
radiographic evidence of angular bone loss of more than or equal to 3mm
pocket probing depth of more than or equal to 5mm |
|
| ExclusionCriteria |
| Details |
past history of periodontal surgery within 1 year
pregnant and lactating mothers
patients who were on antibiotic or non steroidal antiinflammatory drug
patient with systemic diseases
patient with deleterious oral habits such as smoking, tobacco chewing |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| radiographic evidence of bone regeneration in the infrabony defects |
At baseline, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| relative attachment level |
6 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
|
N/A |
|
Date of First Enrollment (India)
|
25/03/2025 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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
|
Patients with infrabony defects caused due to chronic periodontitis will be selected for the study. It is a split mouth study. Randomization will be done and patients will be divided into two groups. Test group will be receiving Demineralized freeze dried bone allograft with placental extract gel into the bony defect while the control group will be receiving demineralized freeze dried bone allograft with placebo gel.The patients will be kept on follow up for a period of 6 months to evaluate the bone regeneration and relative clinical attachment level. |