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CTRI Number  CTRI/2024/05/067060 [Registered on: 08/05/2024] Trial Registered Prospectively
Last Modified On: 01/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Comparative Evaluation Of Locally Delivered Gels Adjunct To Scaling And Root Planing 
Scientific Title of Study   Comparative Evaluation of Chronic Periodontitis Patients Treated with Scaling and Root Planing (SRP) along with Metronidazole Gel Alone or Metronidazole in Combination with Chlorhexidine Gel – 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  Asmita Ghanti 
Designation  MDS PGT Student 
Affiliation  Guru Nanak Institute of Dental Sciences and Research 
Address  157/F, Nilgunj Rd, Sahid Colony, Panihati, Kolkata, Khardaha, West Bengal 700114

Kolkata
WEST BENGAL
700114
India 
Phone  7624855645  
Fax    
Email  asmitaghanti@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Goutam Das 
Designation  Reader 
Affiliation  Guru Nanak Institute of Dental Sciences and Research 
Address  157/F, Nilgunj Rd, Sahid Colony, Panihati, Kolkata, Khardaha, West Bengal 700114

Kolkata
WEST BENGAL
700114
India 
Phone  9830283502  
Fax    
Email  gautam.das@gnidsr.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr. Goutam Das 
Designation  Reader 
Affiliation  Guru Nanak Institute of Dental Sciences and Research 
Address  157/F, Nilgunj Rd, Sahid Colony, Panihati, Kolkata, Khardaha, West Bengal 700114

Kolkata
WEST BENGAL
700114
India 
Phone  9830283502  
Fax    
Email  gautam.das@gnidsr.ac.in  
 
Source of Monetary or Material Support  
Guru Nanak Institute of Dental Sciences and Research,Kolkata 
 
Primary Sponsor  
Name  Asmita Ghanti 
Address  157/F, Nilgunj Rd, Sahid Colony, Panihati, Kolkata, Khardaha, West Bengal 700114 
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 Goutam Das  Guru Nanak Institute of Dental Sciences and Research Hospital  Fourth Floor, Department of Periodontics
Kolkata
WEST BENGAL 		 9830283502

gautam.das@gnidsr.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-GNIDSR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R52||Pain, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Metronidazole and Chlorhexidine gel  Metronidazole 1.5% AND Chlorhexidine gel 0.5% combination,applied locally subgingivally till the base of pocket of teeth by blunt tip needle of syringe only once after 15 days of scaling  
Intervention  Metronidazole gel  Metronidazole gel 1% applied locally subgingivally till the base of pocket of teeth by blunt tip needle of syringe only once after 15 days of scaling. 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Chronic Periodontitis patient without any systemic disease.
2.Adults in age group of 35 to 65 years.
3.Two or more teeth having a periodontal pocket depth of 4-6 mm and Clinical Attachment Loss of greater than 3mm on both quadrants of same arch.
 
 
ExclusionCriteria 
Details  1. Patients having habit of chewing pan, tobacco chewing/smoking habits.
2.Use of antibiotics in previous three months.
3.Allergy to Metronidazole and Chlorhexidine.
4.Patient who received active periodontal treatment within 6 months.
5.Physically challenged patients having other health issues 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Metronidazole gel - Change or no change
2.Combination of Metronidazole and Chlorhexidine gel- change or no change 		 baseline vist, after 15 days, 1 month, 3 month,6months and 9 months 
 
Secondary Outcome  
Outcome  TimePoints 
1.Metronidazole gel - Change or no change
2.Combination of Metronidazole & Chlorhexidine gel- change or no change 		 baseline vist, after 15 days, 1 month, 3 month,6months & 9 months 
 
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 4 
Date of First Enrollment (India)   16/05/2024 
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 - YES
  1. What data in particular will be shared?
    Response (Others) -  nil

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code
    Response (Others) -  nil
  3. Who will be able to view these files?
    Response (Others) -  nil

  4. For what types of analyses will this data be available?
    Response (Others) -  nil

  5. By what mechanism will data be made available?
    Response (Others) -  Any publishing site

  6. For how long will this data be available start date provided 01-09-2026 and end date provided 01-01-2125?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Periodontitis is a chronic multifactorial disease associated with plaque biofilms and characterised by tooth destruction. To combat periodontal disease in addition to patient education , non surgical periodontal therapy is the gold standard but due to limitation of Scaling and root planing (SRP) , local drug delivery is used as an adjunct in one of the treatment modalities . Metronidazole being an antimicrobial and Chlorhexidine is an effective plaque controlling agent.As per the present literature reviews there are limited observations regarding the effect of Metronidazole or metronidazole in combination with chlorhexidine gel for the periodontal treatment, thus with this background a study can be designed for the comparison between SRP with Metronidazole gel or Metronidazole in combination with Chlorhexidine gel  
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