| CTRI Number |
CTRI/2024/10/075696 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Checking the health of gums and bone around dental implants with or without applying drug used to control blood sugar level |
|
Scientific Title of Study
|
An evaluation of periimplant tissues with and without application of 1 percent metformin gel on dental implant surface and in osteotomy site during implantation A Randomized clinical controlled trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vishnudas Bhandari |
| Designation |
Professor and Head of the department |
| Affiliation |
Maharashtra Institute of Dental Sciences and Research dental college Latur. |
| Address |
Room no. 10 First floor, Department of Periodontology and Oral Implantology, Maharashtra Institute of Dental Sciences and Research dental college Latur, MAHARASHTRA 413 512 India.
Latur
MAHARASHTRA
413512
India |
| Phone |
9823525229 |
| Fax |
|
| Email |
vishnudas.bhandari@mitmidsr.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geeta Bhutda |
| Designation |
postgraduate student |
| Affiliation |
Maharashtra Institute of Dental Sciences and Research dental college Latur. |
| Address |
Room no. 10 First floor, Department of Periodontology and Oral Implantology, Maharashtra Institute of Dental Sciences and Research dental college Latur, MAHARASHTRA 413 512 India.
Latur
MAHARASHTRA
413512
India |
| Phone |
9119590907 |
| Fax |
|
| Email |
geetabhutda62729@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geeta Bhutda |
| Designation |
postgraduate student |
| Affiliation |
Maharashtra Institute of Dental Sciences and Research dental college Latur. |
| Address |
Room no. 10 First floor, Department of Periodontology and Oral Implantology, Maharashtra Institute of Dental Sciences and Research dental college Latur, MAHARASHTRA 413 512 India.
Latur
MAHARASHTRA
413512
India |
| Phone |
9119590907 |
| Fax |
|
| Email |
geetabhutda62729@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no. 10 first floor, Department of Periodontology and Implantology, Maharashtra Institute of Dental Sciences and Research Dental College, Latur,Maharashtra 413512, India |
|
|
Primary Sponsor
|
| Name |
Dr Geeta Bhutda |
| Address |
Room no. 10 first floor, Department of Periodontology and Implantology, Maharashtra Institute of Dental Sciences and Research Dental College, Latur. |
| Type of Sponsor |
Other [self] |
|
|
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 vishnudas Bhandari |
Maharashtra Institute of Dental Sciences and Research |
Room no. 10 first floor, Department of Periodontology and Implantology, Maharashtra Institute of Dental Sciences and Research Dental College, Latur,MAHARASHTRA
Latur
MAHARASHTRA |
9823525229
vishnudas.bhandari@mitmidsr.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, MIDSR Dental College, Latur |
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 |
| Comparator Agent |
Placement of screw form dental implant in edentulous ridges without applying metformin gel |
Dental implants will be placed in prepared osteotomy site using conventional two stage protocol without any surface treatment by metformin gel and duration of study will be 18 months |
| Intervention |
Placement of screw form of dental implant with metformin gel application on its surface |
Dental implants will be placed in prepared osteotomy site using conventional two stage protocol with 1% metformin gel application over the implant surface and duration of study will be 18 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Both genders.
Subjects with ages ranging from 18 to 75 years.
Partially edentulous subjects and wants to replace their missing teeth.
Systemically healthy subjects without having any medical illness that can impact the surgical protocol. (ASA Grade 1 or 2).
Patients sign a written consent form. |
|
| ExclusionCriteria |
| Details |
Subjects with uncontrolled diabetes
Subjects with poor oral hygiene. {Plaque Index (PI) ≥1}
Pregnant and lactating females.
Subjects who are alcoholics
Patients who are using bisphosphonates
Subjects with severe clenching and grinding (parafunctional habits)
Active infection or severe inflammation at the planned implant site
Physically handicapped and mentally disabled subjects.
Patient with history of bone augmentation surgery
Participants had known allergies to the drugs used for the study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cresta bone level change |
At implant placement, at implant uncovery and
and 3 months post prosthetic delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Stability of bucco-lingual dimensions at baseline
and 3 months post prosthetic delivery. |
at baseline and 3 months post prosthetic
delivery. |
| Bone density using Cone Beam Computed Tomography |
3 months after prosthetic delivery. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 4 |
|
Date of First Enrollment (India)
|
25/11/2024 |
| 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 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [geetabhutda62729@gmail.com].
- For how long will this data be available start date provided 01-09-2026 and end date provided 01-09-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Modern dentistry aims to restore the oral
health of patients in a predictable fashion. Depending on an individual’s local,
environmental, physiological, mental, and financial status, the lost teeth are replaced
with the best possible alternative.The use of dental implants for treating complete
or partial edentulism is a widely accepted treatment option as a result of its high rate
of success. Metformin is an oral biguanide antidiabetic drug. It is a commonly used medication
administered to patients with DM2, polycystic ovarian syndrome, and metabolic
syndrome. Metformin improves periodontal health by controlling blood sugar levels
and increasing the outcomes of periodontal therapy. More recent studies have
indicated that it may have a direct antiresorptive effect on periodontal bone.
Metformin inhibits bone resorption by reducing receptor activator of nuclear factor
kappa B ligand (RANKL) expression and increasing osteoprotegerin (OPG) expression. Enhancing osteoblast proliferation and reducing osteoclast activity are two possible
mechanisms of action for metformin’s osteogenic impact. Given its capacity to regulate blood glucose levels and promote bone repair,
investigating the potential of metformin (MF) in bone physiology holds significant
value. The potential application of metformin as an adjunct to dental implants could
offer novel insights into bone physiology. The impact of locally applying metformin to
the implant surface during implantation has not been extensively studied in the
literature, so the aim of this study is to evaluate the clinical and radiographic
effectiveness of 1% metformin gel when applied over the implant surface and at the
osteotomy site. |