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CTRI Number  CTRI/2023/12/060472 [Registered on: 04/12/2023] Trial Registered Prospectively
Last Modified On: 01/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Effectiveness of hydrogen peroxide on oral hygiene 
Scientific Title of Study   Effectiveness of hydrogen peroxide solution on oral hygiene among patients admitted in ICU of selected hospitals of Gangtok, Sikkim 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nisha Acharya 
Designation  M.Sc Nursing student, Medical Surgical Nursing 
Affiliation  Indian Nursing Council, State Nursing Council, NAAC  
Address  Sikkim Manipal College of Nursing,Sikkim Manipal University, 5th Mile Tadong, Gangtok

East
SIKKIM
737102
India 
Phone  9907949682  
Fax    
Email  nishacharya345@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mrs. W. Ashalata Devi 
Designation  Professor, Head of department Medical Surgical Nursing 
Affiliation  Indian Nursing Council, State Nursing Council, NAAC  
Address  Sikkim Manipal College of Nursing, Sikkim Manipal University, 5th Mile Tadong, Gangtok

East
SIKKIM
737102
India 
Phone  9734801181  
Fax    
Email  wangkheimayum.ad@smims.smu.edu.in  
 
Details of Contact Person
Public Query  
Name  Mrs. Sandhya Gurung 
Designation  Assistant Professor, Medical Surgical Nursing Department 
Affiliation  Indian Nursing Council, State Nursing Council, NAAC  
Address  Sikkim Manipal College of Nursing, Sikkim Manipal University, 5th Mile Tadong, Gangtok

East
SIKKIM
737102
India 
Phone  8967035767  
Fax    
Email  sandhya.g@smims.smu.edu.in  
 
Source of Monetary or Material Support  
Sikkim Manipal College of Nursing 
 
Primary Sponsor  
Name  Sikkim Manipal College of Nursing 
Address  5th Mile Tadong, Gangtok,Sikkim- 737102 
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 Aradhna Nazareth  Central Referral Hospital (CRH) and new Sir Thutob Namgyal Memorial (STNM) Hospital  Department of Critical Care Units
East
SIKKIM 		 9330936450

aradhna.s@smims.smu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sikkim Manipal Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K056||Periodontal disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1.5% hydrogen peroxide oral solution  I will provide oral care with hydrogen peroxide BD for 3 days. 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Patient who are unconscious and who are in mechanical ventilation 
 
ExclusionCriteria 
Details  1.Patient diagnosed with mandible fracture, oral infection such as thrush or oral candidiasis, oral herpes.
2.Patient who are taking treatment of oral infection/ diseases.
3.Patient whose BOAS score is 16 – 20.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Mouth care by hydrogen peroxide improves the oral hygiene among ICU patients.
 		 3 days 
 
Secondary Outcome  
Outcome  TimePoints 
It helps to prevent the respiratory tract infection related to hospitalization.
 		 4 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   11/12/2023 
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="1"
Days="15" 
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   Oral health is a key indicator of overall health, well - being and quality of life. The WHO Global oral health Status rEPORT ( 2022) estimated that oral diseases affect close to 3.5 billion people worldwide. Patients in hospital, especially those in ICU need specialized care. Ventilator associaed pneumonia ( VAP) is the most common nosocomal infection. One major factors causing VAP is the aspiration of oral colonization because of poor oral practice. Oral complication may arise as a result of the medical treatment delivered in an ICU. Intubation of the mouth causes, xerostoma, mucositis, gingivitis, halitosis. Hydrogen peroxide is a colorless with a strong oxidizing activity that has been used as a anti - plaque agent and has a killing effect on gram positive and gram negative bacteria. It effectively reduces gingival infections.so as a investigator i want to see the effect of hydrogen peroxide on oral hygiene among patient admitted in ICU. the objectives of my study are:
1.To assess the level of oral hygiene among patients admitted in ICU.
2. To assess the effectiveness of hydrogen peroxide solution on oral hygiene among patients admitted in ICU. 
3. To find the association between the level of oral hygiene among patients admitted in ICU.

 
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