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CTRI Number  CTRI/2025/03/082985 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 26/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry
Other (Specify) [insulin like growth factor]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Examining How Insulin-like Growth Factor Helps Bone Growth and Implant Support in patients with missing teeth 
Scientific Title of Study   Evaluation Of The Effect Of Insulin like Growth Factor Application On Crestal Bone Level And Osseointegration Around Endosseous Implant. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Lakshmi Kanth Kolaparthy 
Designation  Professor 
Affiliation  Sibar Institute of Dental Sciences 
Address  Room no: 8, Second Floor, Department of Periodontology, Sibar Institute OF Dental Sciences, Takkellapadu, Guntur

Guntur
ANDHRA PRADESH
522509
India 
Phone  9441081047  
Fax    
Email  drkanth99@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Lakshmi Kanth Kolaparthy 
Designation  Professor 
Affiliation  Sibar Institute of Dental Sciences 
Address  Room no: 8, Second Floor, Department of Periodontology, Sibar Institute OF Dental Sciences, Takkellapadu, Guntur


ANDHRA PRADESH
522509
India 
Phone  9441081047  
Fax    
Email  drkanth99@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Lakshmi Kanth Kolaparthy 
Designation  Professor 
Affiliation  Sibar Institute of Dental Sciences 
Address  Room no: 8, Second Floor, Department of Periodontology, Sibar Institute OF Dental Sciences, Takkellapadu, Guntur


ANDHRA PRADESH
522509
India 
Phone  9441081047  
Fax    
Email  drkanth99@yahoo.co.in  
 
Source of Monetary or Material Support  
Material support 
 
Primary Sponsor  
Name  Nextin Biocare Pvt Ltd 
Address  Rajkot, Gujarat 
Type of Sponsor  Other [implant manufacturer] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrKLakshmi Kanth  Sibar Institute Of Dental Sciences  Room no:8, Department of Periodontology
Guntur
ANDHRA PRADESH 
9441081047

drkanth99@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Sibar Institute of Dental Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, (2) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Insulin like growth factor  implants will be coated with Insulin like growth factor gel and patients will be followed up 3 and 6 months for evaluating parameters 
Comparator Agent  with out insulin like growth factor  implants will not be coated with Insulin like growth factor gel and patients will be followed up 3 and 6 months for evaluating parameters 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Individuals with an age group of 25-50 years of either gender.
2. Presence of adequate horizontal(4-5mm) and vertical (12mm) dimensions of the alveolar bone based on CBCT.
3. Presence of adequate keratinized mucosa (minimum 1 mm) in the edentulous site.
4. Apparently healthy individuals.
5. Individuals with bone density classified as D2 and D3 type of bone.
 
 
ExclusionCriteria 
Details  1. Any forms of tobacco users.
2. Individuals with parafunctional habits.
3. Pregnant and lactating women.
4. Patients taking any medication which effect healing and bone metabolism.
5. History of radiotherapy to head and neck.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
to evaluate implant stability around implants coated with insulin like growth factor  base line, 3 months and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
to evaluate the crestal bone level around implants coated with insulin like growth factor  baseline, 3 and 6 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/04/2025 
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)   Not Applicable 
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  

we will be evaluate the effect of IGF-1 gel coating on implant stability and crestal bone level on endosseous implants. this study is going to access the implant stability and crestal bone level around implants coated with and with out insulin like growth factor. Patients having edentulous sites and willing for implant placement will be selected from the Out Patient Department of Periodontology, Sibar Institute of Dental Sciences, Guntur, Andhra Pradesh, India. patients will be selected by the following criteria:   Individuals with an age group of 25-50 years of either gender,  Presence of adequate horizontal(4-5mm) and vertical (12mm) dimensions of the alveolar bone based on CBCT. ,Presence of adequate keratinized mucosa (minimum 1 mm) in the edentulous site., Apparently healthy individuals. Individuals with bone density classified as D2 and D3 type of bone. patients with any forms of tobacco users, Individuals with parafunctional habits, Pregnant and lactating women, Patients taking any medication which effect healing and bone metabolism, History of radiotherapy to head and neck. will bot be selected in the study. Total of 40 apparently healthy subjects will be selected into study. They will be randomly assigned into two groups consisting of 20 patients in each group according to the inclusion and exclusion criteria.  Group 1(Control group): Implants without IGF-1 gel(n=20).  Group 2(Test group): Implants coated with IGF-1 gel(n=20). IGF gel will be procured from Periobiologics LLP company in a 2cc syringe gel form. Implant size of 3.5mm width and 10mm in length will be used in the study. The study will be carried out for one and half year duration. And Patients with edentulous sites in the mandibular and maxillary arches with adequate alveolar ridge width and height will be considered into the study. Ridge characteristics will be measured clinically as well as radiographically with the help of CBCT. Sites fulfilling the study criteria will be included into the study. the following parameters will be evaluated at base line , 3 and 6 months, implants stability and radiographic bone level. methodology will be : Before surgery the patients will be advised to rinse with 5% povidone iodine mouthwash.,the procedure will be performed under local anaesthesia using 2% lignocaine containing adrenaline 1:80,000.  After adequate local anaesthesia with 2% lignocaine, a mid-crestal incision is given in both the cases.  A mucoperiosteal flap will be  elevated and osteotomy site will be prepared.  In Group 1(Control group) patients, implants will be placed without IGF-1 gel coating and in Group 2(Test group) implants will be coated with IGF-1gel. After placement, stability will be checked by RFA at baseline.  Cover screw will be given following the implant placement. Flaps will be approximated and sutured. Instructions regarding oral hygiene maintenance and soft diet plan will be provided. Patients will be discharged after prescribing analgesics and antibiotics.Patient will be recalled after 1 week for suture removal. crown placement will be done after 3 months. 

 

 


 
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