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CTRI Number  CTRI/2026/02/103514 [Registered on: 10/02/2026] Trial Registered Prospectively
Last Modified On: 10/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficacy of different oral hygiene methods on the reduction of bad breath in healthy young adults  
Scientific Title of Study   Effectiveness of different oral hygiene regimens on the reduction of halitosis in healthy young adults – a randomized clinical 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  Dr PADMA REDDY 
Designation  PROFESSOR 
Affiliation  Panineeya Mahavidyalaya Institute of Dental sciences and research centre 
Address  Room no 201, Department of Public health dentistry, Panineeya Mahavidyalaya Institute of Dental sciences and research centre,road no 5 ,kamala nagar,Dilsukh nagar, Hyderabad.

Hyderabad
TELANGANA
500060
India 
Phone  9248017887  
Fax    
Email  drprphd07@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr PADMA REDDY 
Designation  PROFESSOR 
Affiliation  Panineeya Mahavidyalaya Institute of Dental sciences and research centre 
Address  Room no 201, Department of Public health dentistry, Panineeya Mahavidyalaya Institute of Dental sciences and research centre,road no 5 ,kamala nagar,Dilsukh nagar, Hyderabad.

Hyderabad
TELANGANA
500060
India 
Phone  9248017887  
Fax    
Email  drprphd07@gmail.com  
 
Details of Contact Person
Public Query
 
Name  MURALI KRISHNA 
Designation  Postgraduate 
Affiliation  Panineeya Mahavidyalaya Institute of Dental Sciences and Research Centre 
Address  Room no 201, Department of Public health dentistry, Panineeya Mahavidyalaya Institute of Dental sciences and research centre,road no 5 ,kamala nagar,Dilsukh nagar, Hyderabad.

Hyderabad
TELANGANA
500060
India 
Phone  8374769996  
Fax    
Email  muralibds362003@gmail.com  
 
Source of Monetary or Material Support  
Panineeya Mahavidyalaya Institute of Dental Sciences and research centre Road no 5 Kamalanagar Dishuknagar Hyderabad Telanagana 500065 India  
 
Primary Sponsor  
Name  Panineeya Mahavidyalaya Institute of Dental sciences and research centre 
Address  Road no5,kamalanagar, Dilsukhnagar, Hyderabad, Telangana. 500060 
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 MURALI KRISHNA  Panineeya Mahavidyalaya Institute of Dental Sciences and research centre  Room no 201 Department of public health dentistry Road no 5 kamala nagar Dilshuknagar Hyderabad Telangana 500065 India
Hyderabad
TELANGANA 
8374769996

muralibds362003@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Communication of Decision of Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Gingivitis, Halitosis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group 1 Brushing with tooth paste in subjects with halitosis  14 days 
Intervention  Group 2-4 Brushing with tooth paste + tongue scraping, Brushing with tooth paste + tongue scraping + mouthwash rinsing with chlorhexidine mouthwash, Brushing with tooth paste + tongue scraping + mouthwash rinsing with probiotic mouthwash in subjects with halitosis  14 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  with minimum halitosis score
with fair to poor gingival and plaque score
willing to participate in the study  
 
ExclusionCriteria 
Details  with history of systemic conditions
antibiotic therapy in the past 3 months
acute sinusitis
caries and periodontal disease
underwent gingival or periodontal treatment in the past 3 months
subjects performing oral hygiene procedures other than brushing 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Plaque Index
Gingival Index
Halitosis score 
Base line
7th day
14th day 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  Base line
7th day
14th day 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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 1 
Date of First Enrollment (India)   27/02/2026 
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="14" 
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  
To evaluate and compare the effectiveness of tooth brushing, tongue scraping, mouthwash rinsing with 2% w/v chlorhexidine mouthwash, mouthwash rinsing with probiotic mouthwash on plaque scores, gingival scores, halitosis scores.
A double blinded parallel randomized clinical trial.
The study will be conducted among young adults, (aged 18–25 years) residing in one of the nongovernmental organizations (NGOs) in Hyderabad.
sample size is 84, with 21 in each group.

Subjects in the age group of 18-25years
With a minimum halitosis score of   >_2 according to Hali meter 
With fair to poor gingival and plaque scores 
Willing to participate in the study are included.

With history of Systemic conditions 
Antibiotic therapy in the past 3 months 
Acute sinusitis
Oral conditions like dental caries and Periodontal disease (pocket depth and CAL)
Underwent gingival or periodontal treatment in the past 3 months.
Subjects performing oral hygiene procedures other than brushing will be excluded from study.
All eligible subjects will be given oral and written information about the purpose of the study
Informed consent will be obtained from the study subjects. Ethical clearance obtained from the Institutional ethics committee
 84 were randomly allocated into four groups with 21 in each group

Group I : Tooth brushing only using a toothbrush(medium) with fluoridated toothpaste (sodium fluoride –1000 ppm).
          
Group II: Tooth brushing (medium) and tongue scraping (Tongue cleaner)
         
Group III: Tooth brushing and tongue scraping (Tongue Cleaner); and use of mouthwash (CHX mouth rinse [0.2% w/v CHX gluconate solution)

Group IV: Tooth brushing, tongue scraping (Tongue Cleaner); and use of probiotic mouthwash.

Random allocation of study subjects in each group was performed using the lottery     method. The examiner and the study subjects will be blinded towards the allocation of participants.The group allocation and concealment of procedure will be carried out independently by a separate investigator not included in the study procedure
  
The following information will be collected from each subject.
The demographic details such as age, gender, and education.
Subjects will be assigned with the different oral hygiene regimens advised to follow for 14 days.
Examination will be done base line (1st day), 7th, 14th day to assess,
A) Plaque Index (PI) (Silness P and Loe H)
B) Gingival Index (GI) (Loe and Silness)
C) Halitosis score

Subjects allotted with the different groups will be given instructions for oral hygiene methods.  

 
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