| CTRI Number |
CTRI/2024/05/067922 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
27/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of 1% Metformin gel on bone density. |
|
Scientific Title of Study
|
Comparative evaluation of bone density in posterior maxilla in patients treated with dental implants alone, dental implants with 1% metformin gel coating and dental implants with 1% metformin gel coating along with CGF- A clinico-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 |
Tushar Mohata |
| Designation |
post graduate student |
| Affiliation |
Ranjeet Deshmukh Dental college and Research Center |
| Address |
104, Department of Periodontics and Implantology
Ranjeet Deshmukh Dental College and Research Centre
Digdoh Hills, Hingna road
Nagpur 440019
Nagpur MAHARASHTRA 440032 India |
| Phone |
9970024685 |
| Fax |
|
| Email |
tushargmohata@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Abhay Kolte |
| Designation |
Dean and HOD |
| Affiliation |
Ranjeet Deshmukh Dental college and Research Center |
| Address |
104, Department of Periodontics and Implantology Ranjeet
Deshmukh Dental College and Research Centre, Digdoh Hills,
Hingna road Nagpur 440019
Nagpur MAHARASHTRA 440019 India |
| Phone |
9011071467 |
| Fax |
|
| Email |
drabhaypkolte@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Abhay Kolte |
| Designation |
Dean and HOD |
| Affiliation |
Ranjeet Deshmukh Dental college and Research Center |
| Address |
104, Department of Periodontics and Implantology Ranjeet
Deshmukh Dental College and Research Centre, Digdoh Hills,
Hingna road Nagpur 440019
Nagpur MAHARASHTRA 440019 India |
| Phone |
9011071467 |
| Fax |
|
| Email |
drabhaypkolte@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ranjeet Deshmukh Dental College and Research Centre
Digdoh Hills, Hingna road
Nagpur Maharashtra India 440019
|
|
|
Primary Sponsor
|
| Name |
Dr Tushar Mohata |
| Address |
104, Department of Periodontics and Implantology
Ranjeet Deshmukh Dental College and Research Centre
Digdoh Hills, Hingna road
Nagpur 440019
|
| Type of Sponsor |
Other [self sponsered pg thesis ] |
|
|
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 Tushar Mohata |
Ranjeet Deshmukh Dental College and Research Center |
104, Department of Periodontics and Implantology
Ranjeet Deshmukh Dental College and Research Centre
Digdoh Hills, Hingna road
Nagpur 440019
Nagpur MAHARASHTRA |
9970024685
tushargmohata@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ranjeet Deshmukh Dental College and Research Centre Ethics Committee |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1% metformin gel and concentrated growth factor(CGF) coating around dental implants during placement |
Dental Implant coated with 1% metformin gel coating and CGF will be placed in posterior region of maxilla |
| Intervention |
1% metformin gel coating around dental implants during placement |
Dental implant coated with 1% metformin gel coating will be placed in posterior region of maxilla |
| Comparator Agent |
No coating around dental implants during placement |
Dental implant placement without any coating will be placed in posterior maxilla |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patient aged between 20 and 55 years
Patient having edentulous space in maxillary posterior region
Patients having good general and systemic health
Co-operative, motivated and hygiene conscious patients
|
|
| ExclusionCriteria |
| Details |
Patients requiring direct or indirect sinus lift procedures
Patients with active infection or severe inflammation at planned implant site
Patients under treatment with drugs which significantly impact periodontal inflammation and bone turnover
Alcoholics, Smokers and patients with poor oral hygiene
Patients with severe clenching and grinding
Pregnant or lactating females
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the effects on bone density in posterior maxilla in patients treated with dental implants alone, dental implants with 1% metformin gel coating and dental implants with 1% metformin gel coating along with CGF |
baseline, 3 , 6 and 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare crestal bone height, buccal bone thickness, ridge width and vertical distance in patients treated with dental implants alone, dental implants with 1% metformin gel coating and dental implants with 1% metformin gel coating along with CGF |
baseline and 9 months |
| To evaluate and compare modified plaque index, sulcular bleeding index, implant sulcus depth, gingival thickness and ridge width in patients treated with dental implants alone, dental implants with 1% metformin gel coating and dental implants with 1% metformin gel coating along with CGF |
baseline, 3 ,6 and 9 months |
|
|
Target Sample Size
|
Total Sample Size="42" Sample Size from India="42"
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)
|
08/06/2024 |
| 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="6" 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
|
This randomized
controlled trial will be conducted to evaluate bone density in posterior
maxilla in patients treated with dental implants alone, dental implants with 1%
metformin gel coating and dental implants with 1% metformin gel coating along
with concentrated growth factors (CGF).
Total 42 sites will be included in the study
which will be divided into following groups:
Group I
(Control Group):
Delayed implant placement without any coating in posterior maxilla. (n= 14 Sites)
Group II
(Test Group 1): Delayed
implant placement with 1% metformin gel coating in posterior maxilla. (n= 14
Sites)
Group
III (Test Group 2):
Delayed implant placement with 1% metformin gel coating along with CGF in
posterior maxilla. (n= 14 Sites)
All
patients will go thorough clinical
evaluations, and case histories will be recorded. Cone-beam computed tomography
(CBCT) will be performed prior to the
surgery to evaluate the quantity and quality of bone as well as to mark the
important anatomical landmarks. Additionally, complete blood analyses,
including, estimations of blood glucose levels, bleeding and clotting times,
and viral screening for HIV, hepatitis B virus, and hepatitis C virus will be
carried out.
Metformin
gel preparation will be done using appropriate methods.
Crestal and
sulcular incisions will be performed and a full-thickness mucoperiosteal flap
will be raised and reflected. The osteotomy site will be prepared using drills
in sequential order.
In the Group I (Control group), implants will
be inserted without any coating in the prepared osteotomy while in Group II
(Test group 1) implants will be inserted along with a thin layer of 1% MF gel
coating and in Group III (Test group 2) implants will be inserted along with a
thin layer of 1% MF gel coating along with CGF. The flaps will be sutured with
3-0 nonabsorbable silk sutures.
Standard
postoperative instructions will be given, along with antibiotics and
analgesics. Suture removal will be done at
7th day. Follow-up visits will be scheduled at 3 and 9 months,
postoperatively.
The
following clinical parameters
will be evaluated:
1. Mombelli’s modified Plaque index
(mPI),
2. Mombelli’s modified sulcular
bleeding index (mSBI)
3. Implant sulcus depth – will be measured
using periodontal implant probe.
4. Ridge width measurement- It will be
done using Bone Gauge at 2mm and 4mm from
alveolar crest.
5. Gingival thickness- will be done
using endodontic spreader with rubber stopper.
Following radiographic parameters
will be evaluated using CBCT at baseline and 9 months.
1. Bone density (BD)– Assessment of
bone density will be done on Image J software.
2. Crestal bone height (CBH)
3. Buccal bone thickness (BT)- At the
crest, 5mm from crest and 10 mm from crest will be assessed using CBCT.
4. Ridge width (RW) – Bucco-lingual
dimension of osseous ridge will be assessed.
5. Vertical distance (VD) between 1st
radiographic bone implant contact and 1st implant thread on mesial and distal
sides and amount of bone loss on mesial and distal side.
Buccal and Palatal gingival thickness measurement will also be done. |