| 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
|
|
|
Primary Sponsor
|
| Name |
Nextin Biocare Pvt Ltd |
| Address |
Rajkot, Gujarat |
| Type of Sponsor |
Other [implant manufacturer] |
|
|
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 |
| 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
|
|
|
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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