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CTRI Number  CTRI/2022/09/045284 [Registered on: 07/09/2022] Trial Registered Prospectively
Last Modified On: 19/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Tooth staining effect oftwo mouthwashes among old-age people living in an old-age home 
Scientific Title of Study   Comparison of tooth staining effect of chlorhexidine mouthwashes with and without Anti-Discoloration System among Institutionalized geriatric population - A Randomized controlled trial 
Trial Acronym  CADS TRIAL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Karunanidhi K 
Designation  Second Year Post Graduate 
Affiliation  Meenakshi Ammal Dental College and Hospital 
Address  Department of Public Health Dentistry (Room No. 4), Meenakshi Ammal Dental College and Hospital, Alapakkam Main Road, Maduravoyal, Chennai-600095.

Chennai
TAMIL NADU
600095
India 
Phone  8778431475  
Fax    
Email  karunanidhi12895@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shyam Sivasamy 
Designation  Professor 
Affiliation  Meenakshi Ammal Dental College and Hospital 
Address  Department of Public Health Dentistry(Room No. 4), Meenakshi Ammal Dental College and Hospital, Alapakkam Main Road, Maduravoyal, Chennai-600095.

Chennai
TAMIL NADU
600095
India 
Phone  9884542249  
Fax    
Email  shyamsivyog@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shyam Sivasamy 
Designation  Associate Professor 
Affiliation  Meenakshi Ammal Dental College and Hospital 
Address  Department of Public Health Dentistry(Room No. 4), Meenakshi Ammal Dental College and Hospital, Alapakkam Main Road, Maduravoyal, Chennai-600095.

Chennai
TAMIL NADU
600095
India 
Phone  9884542249  
Fax    
Email  shyamsivyog@gmail.com  
 
Source of Monetary or Material Support  
Meenakshi Ammal Dental college and Hospital, Maduravoyal, Chennai-600095. 
 
Primary Sponsor  
Name  Dr Karunanidhi K 
Address  Meenakshi Ammal Dental College and Hospital, Alapkkam Main Road, Maduravoyal, Chennai-600095. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mohammed Meera Riyaz   SRI SAIRAM OLD AGE HOMES (FOR FEMALES)   GROUND FLOOR, FEMALE OLD-AGE HOME DIVISION, NO. 16/34, HOSPITAL ROAD, CHOLAPURAM, AMBATTUR, CHENNAI - 600062.
Thiruvallur
TAMIL NADU 		 9994622501

meerariyaz.9@gmail.com 
Dr Krithiga Devi B  SRI SAIRAM OLD AGE HOMES (FOR MALES)  FIRST FLOOR, MEN OLD-AGE HOME DIVISON, NO. 16/34, HOSPITAL ROAD, CHOLAPURAM, AMBATTUR, CHENNAI - 600062.
Chennai
TAMIL NADU 		 9940408050

krithigadevi6792@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethical Committee of Meenakshi Ammal Dental College and Hospital, Maduravoyal, Chennai  Approved 
NOC from Site   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patients who are having Periodontitis. 
Patients  (1) ICD-10 Condition: R688||Other general symptoms and signs, (2) ICD-10 Condition: K051||Chronic gingivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Chlorhexidine Mouthwash with anti-discoloration system   Dose: 10 ml twice daily for 15 days Frequency: Twice daily Route of administration: Oral Brand Name: Clohex ADS (Dr.Reddy’s Laboratories) Ingredients: Chlorhexidine 0.20 %, Sodium Fluoride 0.05%, Zinc chloride 0.09%.  
Comparator Agent  Chlorhexidine mouthwash without Anti-discoloration system  Dose: 10 ml twice daily for 15 days Frequency: Twice daily Route of administration: Oral Brand Name: Clohex (Dr. Reddys Laboratories) Ingredients: Chorhexidine 0.20% 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Participants aged more than 60 years of age.
2. Participants who are able to perform tooth brushing and mouth rinsing on their own.
3. Participants who are classified as Periodontitis stage II, III or stage IV according to classification of Tonetti, Greenwell, & Kornman, 2018
4.Participants with intact upper and lower anteriors.
5. Participants willing to participate in the study.
 
 
ExclusionCriteria 
Details  1. Participants with missing of more than two upper and lower anteriors.
2. Participants with fixed partial dentures in upper and lower anteriors.
3. Participants who consume any form of smoke or smokeless tobacco.
4. Participants with psychological disorders.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess and compare the presence of extrinsic staining of teeth after the use of chlorhexidine mouthwashes with and without discoloration system.

 		 At baseline
7 days, 15 days

 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess and compare the plaque content after the use of chlorhexidine mouthwashes with and without discoloration system

2.To assess and compare the presence of Gingival Bleeding after the use of chlorhexidine mouthwashes with and without discoloration system.

3. To assess and compare the adverse effects after the use of chlorhexidine mouthwashes with and without discoloration system.
 		 At baseline, 7 days, 15 days 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/09/2022 
Date of Study Completion (India) 10/10/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
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
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [karunanidhi12895@gmail.com].

  6. For how long will this data be available start date provided 12-05-2022 and end date provided 12-05-2023?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
             Dentists frequently recommend adjunctive oral hygiene aids such  as chlorhexidine (CHX) mouthwashes. CHX represents an effective option for the treatment of plaque‐induced gingival diseases, due to inhibition of bacterial biofilm build‐up and microbial re‐colonization.But use of chlorhexidine mouthwash  may also lead to adverse effects such as  tooth staining, altered taste sensation, mucosal irritation. This reduces patient compliance towards the use of Chlorhexidine mouthwashes. To reduce the adverse effects and improve anti microbial efficacy, several components have been added to chlorhexidine mouthwash. Of that, a plasdone added mouthwash is being marketed as chlorhexidine mouthwash with Anti-Discoloartion System (Clohex ADS). However, there is no scientific evidence regarding evaluation of this mouthwash in prevention of tooth staining. Hence, this study was designed to comparatively evaluate the anti-staining effect of Chlorhexidine mouthwash with and without anti-discoloration system. This study will be conducted as a multi centric triple‐blinded, parallel study among Institutionalized old-age adults. The old age home people will be subjected for clinical examination. Participants meeting the inclusion criteria will be recruited into the study. All the selected participants will undergo complete ultrasonic scaling. In the same session, when professional oral hygiene was completed (T0), clinical indices such as Silness and Loe Plaque Index (1964) Gingival Bleeding Index (GBI—Ainamo Bay), Extrinsic Stain Index (Loebner), Intraoral digital photographs will be recorded for each patient. The participants will be randomly allocated to interventional groups GROUP I: Chlorhexdine Mouthwash Brand Name: Clohex Mouthwash (Dr.Reddy’s Laboratories) Ingredients: Chlorhexidine 0.20 %  GROUP II: Chlorhexidine Mouthwash with Anti-Discoloration System Brand Name: Clohex ADS (Dr.Reddy’s Laboratories) Ingredients: Chlorhexidine 0.20 %, Sodium Fluoride 0.05%, Zinc chloride 0.09%. A standard tooth brush (soft) and toothpaste will be provided to all participants. The participants will be asked to rinse their mouth with 10 ml of mouthwash twice daily for 1 minute. Silness and Loe Plaque Index(1964), Gingival Bleeding Index (GBI—Ainamo Bay), Extrinsic Stain Index (Loebner), intraoral digital photographs will be recorded at 15th day. The plaque levels, gingival bleeding and tooth staining will be compared between the two interventional groups. Patients’s perception towards the use of mouthwash will be recorded using a questionnaire. This study has certain benefits to the study participants.Tooth brushing is quite difficult for institutionalized geriatric population due to their limited manual dexterity. Tooth brushing alone can’t eliminate all the plaque from teeth. Hence, mouthwash use as an adjunctive oral hygiene aid, can bring down the plaque levels and improve the periodontal status of the participants. As well as, the mouthwash with least adverse effect can be evaluated through this trial and can be recommended to bed ridden, physically challenged and geriatric people. Hence, this study results has potential to extend it’s implications to the general population. 

 

 
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