| CTRI Number |
CTRI/2024/09/073358 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
13/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Microbial Analysis of Plaque taken from Implant |
|
Scientific Title of Study
|
Microbial Profiling of Dental Plaque Around Natural Teeth Compared to That of Dental Implants: A Cross-sectional 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 |
Irine Paul |
| Designation |
PG student |
| Affiliation |
PMS College of Dental Science and Research |
| Address |
Room Number 8
Department of Periodontics
PMS College of Dental Science and Research
Venkode
Thiruvananthapuram
KERALA
695028
India |
| Phone |
8921615051 |
| Fax |
|
| Email |
irinepaulputhusaril@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ambili R |
| Designation |
Professor and HOD |
| Affiliation |
PMS College of Dental Science and Research |
| Address |
Room Number 8
Department of Periodontics
PMS College of Dental Science and Research
Venkode
Thiruvananthapuram
KERALA
695028
India |
| Phone |
9447463676 |
| Fax |
|
| Email |
ambilirenjith2020@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ambili R |
| Designation |
Professor and HOD |
| Affiliation |
PMS College of Dental Science and Research |
| Address |
Room Number 8
Department of Periodontics
PMS College of Dental Science and Research
Venkode
Thiruvananthapuram
KERALA
695028
India |
| Phone |
9447463676 |
| Fax |
|
| Email |
ambilirenjith2020@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Periodontics
Room No 8
PMS College of Dental Science and Research
venkode
Trivandrum
India
pin code 695028 |
|
|
Primary Sponsor
|
| Name |
Irine Paul |
| Address |
Dept of Periodontics
Room no 8
PMS College of Dental Science and Research
Venkode
Trivandrum
Pin code 695028 |
| 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 Irine Paul |
PMS College Of Dental Science And Research |
Department Of Periodontics
ROOM NO. 8
PMS College Of Dental Science And Research
Venkode
Pin code 695028
Thiruvananthapuram
KERALA |
8921615051
irinepaulputhusaril@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Certificate PMS College of Dental Science and Research, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy patients with healing abutment of more than 2 weeks duration in at least one implant.
Patients belonging to both sexes aged between 20 - 60 years.
At least one periodontal site with pocket depth less than 3mm and no bleeding on probing.
At least one periodontal site with pocket depth more than or equal to 4 mm with bleeding on probing.
|
|
| ExclusionCriteria |
| Details |
Pregnant and lactating females
Immunocompromised patients
Smokers
Use of probiotics, antibiotics, corticosteroids within 3 months before sampling.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Microbial profiling of Plaque |
Baseline (0)
6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
FMPS
FMBS
PD |
baseline (0)
After 6 months |
|
|
Target Sample Size
|
Total Sample Size="3"
Sample Size from India="3"
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)
|
10/10/2024 |
| 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
|
The oral microbiome that colonizes the oral cavity plays a significant role in periodontal health and disease. Periodontitis is a site-specific disease and is initiated by dysbiosis of the subgingival microbiome. Peri-implantitis shares many similarities in pathogenesis with periodontitis. The presence of periodontitis is considered a risk factor for periimplantitis even though the exact mechanism is not clearly understood. The possibility of microbial transmission for sites with periodontitis to the peri-implant crevice can not be negated. Microbial profiling of early colonizers around implants is poorly understood especially using next-generation sequencing techniques. |