| CTRI Number |
CTRI/2024/09/073395 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
04/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Microbial analysis of P.gingivalis and T.forsythia in mobile and non-mobile teeth. |
|
Scientific Title of Study
|
Quantitative evaluation and comparison of Porphyromonas gingivalis and Tannerella forsythia in mobile and non-mobile teeth: A microbiological 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 |
Dr Alice Jeba |
| Designation |
Post Graduate student |
| Affiliation |
Sri Rajiv Gandhi College of Dental Sciences and Hospital |
| Address |
Room No-12, Department of Periodontology, Sri Rajiv Gandhi College of Dental Sciences and Hospital, Cholanagar, R.T Nagar Post, Bangalore-560032
Bangalore
KARNATAKA
560032
India |
| Phone |
9606820366 |
| Fax |
|
| Email |
jeba080995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Vijay Raghava |
| Designation |
Professor |
| Affiliation |
Sri Rajiv Gandhi College of Dental Sciences and Hospital |
| Address |
Room No-12, Department of Periodontology, Sri Rajiv Gandhi College of Dental Sciences and Hospital, Cholanagar, R.T Nagar Post, Bangalore-560032
Bangalore
KARNATAKA
560032
India |
| Phone |
9844330760 |
| Fax |
|
| Email |
vijayraghava.vr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alice Jeba |
| Designation |
Post Graduate Student |
| Affiliation |
Sri Rajiv Gandhi College of Dental Sciences and Hospital |
| Address |
Room No -12, Department of Periodontology, Sri Rajiv Gandhi College of Dental Sciences and Hospital, Cholanagar, R.T Nagar post, Bangalore-560032
Bangalore
KARNATAKA
560032
India |
| Phone |
9606820366 |
| Fax |
|
| Email |
jeba080995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Rajiv Gandhi College of Dental Sciences and Hospital, Cholanagar, R.T Nagar Post, Bangalore, 560032 |
|
|
Primary Sponsor
|
| Name |
Dr Alice Jeba |
| Address |
#55 Maria Nivas, near Prerana International School Road, Budigere Cross, Virgonagar Post, Bangalore, 560049 |
| Type of Sponsor |
Other [Self Sponsored] |
|
|
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 Alice Jeba |
Sri Rajiv Gandhi College of Dental Sciences and Hospital |
Department of Periodontics Room #12, Cholanagar, R.T Nagar Post, Bangalore, 560032
Bangalore
KARNATAKA |
9606820366
jeba080995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Ethical Committee, Sri Rajiv Gandhi College of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
systemically healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not applicable |
Not applicable |
| Comparator Agent |
Porphyromonas gingivalis and Tannerella forsythia in Mobile teeth and Non-mobile teeth |
Porphyromonas gingivalis and Tannerella forsythia around Miller’s Grade 1 mobile teeth, Porphyromonas gingivalis and Tannerella forsythia around Miller’s Grade 2
mobile teeth, Porphyromonas gingivalis and Tannerella forsythia around Miller’s Grade 3
mobile teeth, Porphyromonas gingivalis and Tannerella forsythia around Non-mobile teeth.
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Subjects should be in between the age group of 35-55 years, Presence of Chronic periodontitis, Subjects without the history of invasive periodontal therapy in the previous six months. |
|
| ExclusionCriteria |
| Details |
Subjects with systemic diseases and infections, Subjects with chronic smoking, Subjects undergoing orthodontic treatment, Subjects with trauma from occlusion, Subjects with Endo-perio lesion |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality and quantity of Porphyromonas gingivalis and Tannerella forsythia, microbial load around mobile and non-mobile teeth. |
Samples are collected at the baseline itself. This is a cross-sectional study design without follow ups. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality & quantity of Porphyromonas gingivalis & Tannerella forsythia around mobile & non-mobile teeth in chronic periodontitis. |
Time point is same as the baseline. All the microbial samples are collected at baseline. There is no intervention in the study. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 1 |
|
Date of First Enrollment (India)
|
16/09/2024 |
| 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="0"
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
|
Porphyromonas gingivalis and Tannerella
forsythia are gram negative periodontal pathogens causing periodontal
destruction by the loss of supporting structures and brings about tooth
mobility. Thus, the present study was conducted to quantitatively evaluate
Porphyromonas gingivalis and Tannerella forsythia micro-organisms around mobile
and non-mobile teeth in chronic periodontitis subjects.
A total of 40 Samples are taken of which 10 samples (Group-A) of
non-mobile teeth, 10 samples (Group-B) of Grade І mobile teeth, 10 samples
(Group-C) of Grade â…¡ mobile teeth, and 10 samples (Group-D) of Grade â…¢ mobile
teeth in chronic periodontitis subjects. Mobility is scored according to Miller’s grading criteria
and scores are recorded. Sub-gingival plaque sample was collected using Gracey
curettes from the deepest periodontal pockets and sent to the laboratory for
the microbial analysis of CFUs of P. Gingivalis and T. Forsythia.
The
mean CFUs of P. Gingivalis between 4 groups exhibited a statistically
significant difference at p<0.001. Multiple comparison between groups
revealed that the Group D demonstrated significantly highest mean CFUs as
compared to other groups at p<0.001 & p=0.002 respectively.
The
mean CFUs of T. Forsythia between 4 groups exhibited a statistically
significant difference at p<0.001. Multiple comparison between groups
revealed that the Group D demonstrated significantly highest mean CFUs as
compared to Group A, B & C at p<0.001 & p=0.003 respectively.
The
mean CFUs of P. Gingivalis was significantly higher in all groups as compared
to T. Forsythia, and the mean differences were statistically significant at
p<0.001, expect in Group A (Firm teeth).
However,
no significant difference in the mean CFUs of P. Gingivalis and T. Forsythia
was observed with respect to Group A [p=0.17].And the mean CFUs of P.gingivalis
and T.forsythia was highest in Group D
(Grade â…¢ mobility) which was followed by Group C (Grade â…¡), Group B (Grade â… ),
Group A (Firm teeth) in our study.
Therefore
in the present study group D (Grade â…¢ mobility) exhibited higher microbial load
compared to other groups. And P. gingivalis number was significantly higher in
the sub-gingival
microbiota of mobile and non-mobile teeth compared to T. forsythia in the
present study. Hence, P.gingivalis and T.forsythia play a major role in the
pathogenesis by bringing about periodontal destruction, tooth mobility, and
finally morbidity of teeth. |