| CTRI Number |
CTRI/2024/07/071735 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
27/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Locally Delivered 3% Gauva Gel and Probiotic Gel in Chronic Periodontitis Patients |
|
Scientific Title of Study
|
An Exploratory Comparative Study of the Efficacy of Locally Delivered 3 Percent Psidium Guajava Gel and Probiotic Gel as an Adjunct to Non Surgical Periodontal Therapy in Chronic Periodontitis- A Clinical and Microbiological Assay |
| 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 Hima Bindu |
| Designation |
Reader |
| Affiliation |
Panineeya Mahavidyala institute of dental sciences and research centre |
| Address |
Room no. 101 , Departement of periodontics Panineeya Mahavidyalaya institute of dental sciences and research centre , road no.5 Dilusukhnagar , hyderabad
Hyderabad TELANGANA 500060 India |
| Phone |
9959200225 |
| Fax |
|
| Email |
bindurakasi@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Hima Bindu |
| Designation |
Reader |
| Affiliation |
Panineeya Mahavidyala institute of dental sciences and research centre |
| Address |
Room no. 101 , Departement of periodontics Panineeya Mahavidyalaya institute of dental sciences and research centre , road no.5 Dilusukhnagar , hyderabad
TELANGANA 500060 India |
| Phone |
9959200225 |
| Fax |
|
| Email |
bindurakasi@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Kanchanpally Sai Pranavi |
| Designation |
Post graduate |
| Affiliation |
Panineeya Mahavidyala institute of dental sciences and research centre |
| Address |
Room no. 101 , Departement of periodontics Panineeya Mahavidyalaya institute of dental sciences and research centre , road no.5 Dilusukhnagar , hyderabad
Hyderabad TELANGANA 500060 India |
| Phone |
9010118444 |
| Fax |
|
| Email |
kanchapallysaipranavi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Panineeya Mahavidyalaya Institute of Dental Sciences and Research centre, road no. 5 , kamalanagar Dilsukhnagar, Hyderabad 500060 |
|
|
Primary Sponsor
|
| Name |
Panieenya Mahavidyala Institute of dental sciences and research centre |
| Address |
Road no 5 kamalanagar Dilsukhnagar Hyderabad Telangana 500065. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 KANCHANAPPALY SAI PRANAVI |
Panineeya Mahavidyala Institute of Dental Sciences and Reserach Centre |
Room no 101,Department of periodontics road no 5 kamalanagar Dilsukhnagar hyderabad Hyderabad TELANGANA |
9010118444
Kanchapallysaipranavi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(IEC) |
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 |
group 1 placebo gel |
group 1 application placebo gel
scaling and root planing with application of placebo gel
3 months |
| Comparator Agent |
group 2 application of 3% psidium gujava gel |
application of 3% psidium gujava gel scaling and root planing and application of 3% psidium gujava gel
3 months |
| Comparator Agent |
group 3 application of probiotic gel |
scaling and root planing and application of probiotic gel
3 months |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 25 to 55 years
Probing Pocket Depth (PPD) greater than 5mm
Patients who have not received periodontal therapy, within preceding 6 months of the study
|
|
| ExclusionCriteria |
| Details |
Patients who were on antibiotics/anti inflammatory drugs in the last 3 months
â— Pregnant and lactating females.
â— Medically compromised patients
â— Smokers, tobacco chewers and alcoholics
â— Patients who are allergic to guava and probiotics
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the clinical outcome of locally delivered 3%Psidium guajava gel and probiotic gel.
To evaluate efficacy of locally delivered 3%Psidium guajava gel and probiotic gel on Porphyromonas gingivalis, Treponema denticola, Tanerella forsythia, A. actinomycetemcomitans in chronic periodontitis patients.
|
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Variation in clinical parameters after periodontal therapy |
Base line & 3 months |
|
|
Target Sample Size
|
Total Sample Size="45" Sample Size from India="45"
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)
|
10/08/2024 |
| 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="0" Months="3" 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
|
·
Chronic periodontitis is an infectious disease resulting in
inflammation within the supporting tissues of the teeth, leading to the
progressive attachment loss and bone loss
· Elevated
levels of certain microbiological species are associated with the disease. It
is essential to minimize the microbial load to combat the infection.
· Non
surgical therapy such as scaling and root planing along with certain chemical
antibacterial strategies such as systemic antibiotics and oral rinses and
irrigating agents are generally used.
·
But, none of these therapies have provided significant clinical
benefit in reducing the clinical signs of chronic periodontal disease and also
side effects are not uncommon with systemic antibiotics ·
To overcome this, a new strategy has emerged to deposit
antimicrobials directly into pocket and maintain effective concentration of the
drug for an extended period. This is
known as LOCAL DRUG DELIVERY ·
In an attempt to overcome the limitations of mechanical
debridement and ill effects of chemotherapeutic agents, research still
continues to find new and better alternatives to conventional treatment
protocols.One of the alternatives are the medicinal herbs which has been
extensively used in ayurveda but lacks sufficient research in modern medicine. ·
Psidium guajava , commonly known as guava, has been used in
folk medicine as a therapeutic agent. The leaves of the plant P.
guajava are reported to possess antimicrobial, anti-inflammatory and
antioxidant properties. It has shown inhibitory effects against staphylococcus
aureus,streptococcus mutans,pseudomonas aeruginosa,salmonella
enteritidis,bacillus cereus,proteus spp.,shigella spp.and Escherichia coli
which causes intestinal infections.
·
Probiotics are being used to help in the recolonization of
beneficial bacteria as well as to modulate the immune response. These agents
have been administered in the form of tablets, gums, lozenges, and mouthrinses
to name a few..The most commonly used species of probiotics belong to the
Lactobacillus, Bifidobacterium, Escherichia, Enterococcus, and Bacillus genera.
These probiotic benefits oral health by defending the growth of harmful
bacteria and by modulating mucosal immunity in the oral cavity.
|