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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
● Pregnant and lactating females.
● Medically compromised patients
● Smokers, tobacco chewers and alcoholics
● 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.




 
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