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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  
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 
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  
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,  
 
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.

 
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