| CTRI Number |
CTRI/2025/03/082315 [Registered on: 13/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A comparative clinical and radiographic study between patient undergoing dental implant placement with and without application of somatropin growth hormone. |
|
Scientific Title of Study
|
To comparative evaluation of the effect of local application of somatropin growth hormone on osseointegration and bone density around dental implant clinical and radiographic 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 |
Sonal Kumbare |
| Designation |
Second year post graduate student |
| Affiliation |
Government Dental Cillege Raipur |
| Address |
Room number 12 Department of Periodontics Government dental college Raipur CG india
Raipur
CHHATTISGARH
492001
India |
| Phone |
7768986587 |
| Fax |
|
| Email |
sonalkumbare6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaibhav Tiwari |
| Designation |
Reader |
| Affiliation |
Government Dental College Raipur |
| Address |
Room number 12 Department of Periodontics Government Dental College Raipur CG India
Raipur
CHHATTISGARH
429001
India |
| Phone |
09685220112 |
| Fax |
|
| Email |
cybervt1@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaibhav Tiwari |
| Designation |
Reader |
| Affiliation |
Government Dental College Raipur |
| Address |
Room number 12 Department of Periodontics Government Dental College Raipur CG India
Raipur
CHHATTISGARH
429001
India |
| Phone |
09685220112 |
| Fax |
|
| Email |
cybervt1@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Indian Society of Periodontology Sector 60
Mohali SAS Nagar district Punjab 160059 India |
|
|
Primary Sponsor
|
| Name |
Dr Sonal Kumbare |
| Address |
Room no 12 Department of Periodontics Government Dental College Raipur 492001 India |
| Type of Sponsor |
Other [Government dental college Raipur 492001 India] |
|
|
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 Sonal Kumbare |
Government Dental College Raipur Chhattisgarh |
Room number 12 Department of Periodontics Raipur 429001 india
Raipur
CHHATTISGARH |
7768986587
sonalkumbare6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Human studies Government dental college, Raipur 492001 India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA I Healthy patient
edentolous mandibular and maxillary arches. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Implant without somatropin growth hormone |
the comparator site will not be treated with any growth hormone at any stages of implant placement. |
| Intervention |
Somatotropin human growth hormone 4IU |
Implant will be inserted by topicl application of 4IU 1.2 mg of lyophilised somatropin growth hormone in stage 1 surgery when implant will be placed in the osteotomy site after the application of growth hormone
Growth hormone will not be placed in the stage 2 that is to be planned after 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA (American Society of Anesthesiologists) 1 patient indicates that the patient is a "normal healthy patient" with no systemic disease, a non-smoking individual, and without any significant health issues that would increase the risk of anesthesia or surgical procedures18. Patient with completely or partially edentulous arches.
Patients with adequate bone volume for placement of dental implant.
All women with natural menopause and no previous fractures.
Patients of the age group between 18 to 60 years of age
Patients willing to participate in the study by giving a written consent form
ASA (American Society of Anesthesiologists) 1 patient indicates that the patient is a "normal healthy patient" with no systemic disease, a non-smoking individual, and without any significant health issues that would increase the risk of anesthesia or surgical procedures.Patient with completely or partially edentulous arches.
Patients with adequate bone volume for placement of dental implant.
All women with natural menopause and no previous fractures.
Patients of the age group between 18 to 60 years of age
Patients willing to participate in the study by giving a written consent form
|
|
| ExclusionCriteria |
| Details |
General contraindication to dental implant treatment (uncontrolled diabetes, severe cardiovascular diseases, osteoporosis, and infectious diseases).
Patients with a habit of smoking and alcohol consumption.
Patients with inadequate bone volume for implant placement.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome of the Study-
The primary expected outcome of the study is improved osseointegration and
bone density in dental implants in patients treated with Human-recombinant Somatropin growth hormone (4 iu).
|
time interval between 3 months 6 months and then 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary expected outcome of the study is enhanced bone implant contact due to the application of Humanrecombinant Somatropin growth
hormone 4iu
|
Radiographic analysis will be done by assessing bone density preoperatively Bone density & radiofrequency analysis will be done in 3 months & 6 months |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
15/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/03/2025 |
| 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
Modification(s)
|
This study will assess the effect of locally applied somatropin growth hormone on osseointegration and bone density around dental implants. The study will be done in an edentulous patient with healthy bony ridges in both the maxillary and mandibular arches. Somatropin growth hormone will be applied locally in the osteotomy site before implant placement. Results will be assessed by CBCT evaluation. Results are expected to show enhanced implant stability, faster healing, and increased bone density in the experimental group compared to controls. Somatropin demonstrated potential as a valuable adjunct in improving dental implant outcomes. |