| CTRI Number |
CTRI/2024/05/067110 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To check microorganism count at implant site |
|
Scientific Title of Study
|
Evaluation of antimicrobial action of healing abutment before and after coating with nanoparticles impregnated with essential oil in type 2 diabetic mellitus- a randomized control 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 Pooja Chitlange |
| Designation |
PG student |
| Affiliation |
Sharad Pawar Dental College |
| Address |
202 Department of Prosthodontics and Crown and Bridge, Sharad Pawar Dental College, Sawangi meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9637444029 |
| Fax |
|
| Email |
poojachitlange1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Sathe |
| Designation |
Professor |
| Affiliation |
Sharad Pawar Dental College |
| Address |
202 Department of Prosthodontics and Crown and Bridge, Sharad Pawar Dental College, Sawangi meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
888839833 |
| Fax |
|
| Email |
seemasathe2011@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema Sathe |
| Designation |
Professor |
| Affiliation |
Sharad Pawar Dental College |
| Address |
202 Department of Prosthodontics and Crown and Bridge, Sharad Pawar Dental College, Sawangi meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
888839833 |
| Fax |
|
| Email |
seemasathe2011@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha-442001, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Datta Meghe Institute of Higher Education and Research, Sawangi meghe, Wardha-442001,Maharashtra, India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Pooja Chitlange |
Sharad Pawar Dental College |
202 Department of prosthodontics and crown and bridge, Sharad Pawar Dental College, DMIHER, Sawangi meghe, Wardha-442001, Maharashtra, India
Wardha
MAHARASHTRA |
09637444029
poojachitlange1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research, Swangi Meghe, Wardha-442001,Maharashtra, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nanoparticles coated healing abutment
|
nanoparticles coated healing abutment, saliva swab will be collected on 0, 1st, 7th and 14th day and microbacterial count will be done.
|
| Intervention |
non coated healing abutment
|
non coated healing abutment will be placed, saliva Swab collection on 0, 1st, 7th and 14th day and microbacterial count will be done.
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients indicated for implant prosthesis
2.Patient with type 2 diabetes mellitus
3.Patients above 18 years of age
4.Patient with good periodontal condition
|
|
| ExclusionCriteria |
| Details |
1.Patient with any systemic disease other than diabetes mellitus
2.Patients on antimicrobial therapy
3.Patient with poor oral hygiene
4.Patient with poor periodontal condition
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Expected outcome of the study is that the new nanoparticle coated titanium healing abutment will provides antibacterial and antiadhesive properties against oral early colonizers responsible for biofilm formation. It will decrease the peri-implant mucositis and rate of implant failure. |
0, 1st, 7th and 14th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
N/A |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
20/07/2024 |
| 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 - NO
|
|
Brief Summary
|
Introduction: Dental implants have been validated as a reliable and valid method of replacing lost teeth in recent years, with a primary success rate of roughly 94.6% [1]. Implants are used in nearly every procedure; however, the following specialties fully encompass the use of permanent or temporary biomaterials in combination with metallic and non-metallic materials: ophthalmology, neurosurgery, vascular surgery, orthopaedics, and maxillofacial and cranial surgery. AIM: To evaluate antimicrobial action of healing abutment before and after coating it with nanoparticles impregnated with essential oil. OBJECTIVES: To evaluate growth of staphylococcus aureus, E-coli and Candida albicans on day 0, 1, 7 and 14 after placement of noncoated healing abutment in patients with type 2 diabetes mellitus. To evaluate growth of staphylococcus aureus, E-coli and Candida albicans at the day on day 0, 1, 7 and 14 after placement of nanoparticles coated healing abutment in patients with type 2 diabetes mellitus. Comparative evaluation of growth of staphylococcus aureus, E-coli and Candida albicans on day 0, 1, 7 and 14 after placement of noncoated and nanoparticles coated healing abutment in patients with type 2 diabetes mellitus. Methodology: Total 36 patients with type 2 diabetes mellitus will be included in the study. Patients will be randomly distributed in both the groups i.e. group A and group B. group A will be patients with noncoated healing abutment (n=18) and group B will be patients with nanoparticles coated healing abutment (n=18). For experimental group titanium healing abutment will be precoated with nanoparticles. The healing abutment will be placed in the postgraduate clinic of Department of Prosthodontics and Crown & Bridge. saliva sample (swab collection) will be collected on the day 0, 1, 7 and 14 after placement of healing abutment. Saliva sample will be sent to lab for assessment of growth of staphylococcus aureus, E-coli and candida albicans. The scope of this study is to develop the new and more effective nanoparticle coated healing abutment, that can decrease the number of bacteria and present more beneficial clinical treatments. It will be more beneficial in patients with diabetes mellitus and other systemic diseases, in which the chances of implant failure and microbial infection is more. It can also improve soft tissue integration, osteo-generation and decreases biofilm formation that leads to decrease in implant failure. |