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CTRI Number  CTRI/2025/01/079447 [Registered on: 24/01/2025] Trial Registered Prospectively
Last Modified On: 23/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Probiotic
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing Probiotics and Tetracycline Fibres for Treating long term Gum Disease. 
Scientific Title of Study   Comparative Evaluation of Efficacy of Probiotics and Tetracycline Fibres as a Local Drug Delivery in the Treatment of Chronic Periodontitis Patients- A Split Mouth 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  Anant Mishra  
Designation  Postgraduate Student  
Affiliation  Army college of dental sciences Secunderabad  
Address  Romm No.-10, Pg Clinic, Department of Periodontics, Army college of Dental sciences, Jai-Jawahar Nagar, CRPF Road, Chennapur, Secunderabad-500087.

Hyderabad
TELANGANA
500087
India 
Phone  9131424771  
Fax    
Email  anantmishra096@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Sanjay VAsudevan 
Designation  Professor and HOD 
Affiliation  Army college of dental sciences Secunderabad  
Address  Romm No.-10, Department of Periodontics, Army college of Dental sciences, Jai-Jawahar Nagar, CRPF Road, Chennapur, Secunderabad-500087.

Hyderabad
TELANGANA
500087
India 
Phone  9849062087  
Fax    
Email  drsanjayvasudevan2003@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Anant Mishra  
Designation  Postgraduate Student  
Affiliation  Army college of dental sciences Secunderabad  
Address  Romm No.-10, Pg Clinic, Department of Periodontics, Army college of Dental sciences, Jai-Jawahar Nagar, CRPF Road, Chennapur, Secunderabad-500087.

Hyderabad
TELANGANA
500087
India 
Phone  9131424771  
Fax    
Email  anantmishra096@gmail.com  
 
Source of Monetary or Material Support  
Advanced Biotech Romm No.-10, Pg Clinic, Department of Periodontics, Army college of Dental sciences, Jai-Jawahar Nagar, CRPF Road, Chennapur, Secunderabad-500087. 
Inlife Pharma Romm No.-10, Pg Clinic, Department of Periodontics, Army college of Dental sciences, Jai-Jawahar Nagar, CRPF Road, Chennapur, Secunderabad-500087. 
 
Primary Sponsor  
Name  Anant Mishra 
Address  Romm No.-10, Pg Clinic, Department of Periodontics, Army college of Dental sciences, Jai-Jawahar Nagar, CRPF Road, Chennapur, Secunderabad-500087. 
Type of Sponsor  Other [Self] 
 
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 Anant Mishra  Army College Of Dental Sciences, Secunderabad  Romm No.-10, Department of Periodontics, Army college of Dental sciences, Jai-Jawahar Nagar, CRPF Road, Chennapur, Secunderabad-500087.
Hyderabad
TELANGANA 		 09131424771

anantmishra096@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The ACDS Ethics Committee For Biomedical & Health Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Chronic Periodontitis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Probiotics  SRP + Local Drug Delivery of Probiotics, Dosage is once, locally applied in the gums and followed up for forty five days. 
Intervention  Tetracycline Fibers  SRP + Local Drug Delivery of Tetracycline Fibers, Dosage is once, locally applied in the gums and followed up for forty five days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Age group between 18 – 50 years
Known cases of Chronic Periodontitis having more than 20 teeth.
Systemically healthy patients with no known allergy.
Patients who have not received periodontal or antibiotic therapy for the past 6 months.
 
 
ExclusionCriteria 
Details  Subjects with known hypersensitivity to Tetracycline &/or Probiotics.
Teeth with furcation involvement.
Patients having habit of smoking, alcohol consumption.
Sites with overhanging restorations.
Tooth with periapical disease.
Subjects with orthodontic and prosthodontic appliances.

 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Recording Plaque index, Sulcular Bleeding Index, Pocket probing depth  0-45 days 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical Attachment Level  Baseline, 10 days & 45 days 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   24/03/2025 
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="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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [anantmishra096@gmail.com].

  6. For how long will this data be available start date provided 15-05-2025 and end date provided 15-05-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  
Informed consent is obtained from the participating patients. Patients are assessed for Plaque index, Sulcular Bleeding Index and Pocket probing depth for baseline data. Following the recordings of clinical parameters, scaling and root planing will be performed. Each site will be allocated randomly into two groups i.e.  Group I and Group II. Later Group I will receive Scaling and root planing followed by placement of Probiotics and placement of Coe Pak after completion of procedure. Group II will receive Scaling and root planing followed by placement of Tetracycline fibers and placement of Coe Pak after completion of procedure. The clinical parameters will be recorded again after 45 days.
 
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