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CTRI Number  CTRI/2021/10/037210 [Registered on: 08/10/2021] Trial Registered Prospectively
Last Modified On: 07/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic
Preventive
Screening
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluation of the patient’s satisfaction level and bacterial count following a single application of Silver Diamine Fluoride with and without Potassium Iodide among Community Dwelling elderly people in Chennai city- An Interventional Study. 
Scientific Title of Study   Quantitative and Qualitatively evaluate the patient’s satisfaction level and Streptococcus mutans colony count following a single application of Silver Diamine Fluoride with and without Potassium Iodide among Community Dwelling Geriatric population in Chennai city- An Interventional Study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  C Rajkumar 
Designation  second year post graduate student 
Affiliation  Ragas Dental College and Hospital 
Address  No. 27 Subbu Street Periyagaram Gingee-604202
2/102, East Coast Road, Uthandi, Chennai-600119
Kancheepuram
TAMIL NADU
604202
India 
Phone  9626712641  
Fax    
Email  rajsachin1994@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrIyapparaja P 
Designation  Reader 
Affiliation  Ragas Dental College and Hospital 
Address  Ragas Dental College and Hospital, uthandi, Chennai-600119
2/102 East Coast Road Uthandi Chennai-600119
Kancheepuram
TAMIL NADU
600119
India 
Phone  9840187000  
Fax    
Email  dr.iyapparaj@gmail.com  
 
Details of Contact Person
Public Query
 
Name  C Rajkumar 
Designation  second year post graduate student 
Affiliation  Ragas Dental College and Hospital 
Address  No. 27 Subbu Street Periyagaram Gingee-604202
2/102, East Coast Road, Uthandi, Chennai-600119
Kancheepuram
TAMIL NADU
604202
India 
Phone  9626712641  
Fax    
Email  rajsachin1994@gmail.com  
 
Source of Monetary or Material Support  
Vishranthi old-age home, palavakam 
 
Primary Sponsor  
Name  Dr C Rajkumar 
Address  Ragas Dental College and Hospital 
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 
Revathi  Vishranthi Old-Age Home  No. 4/227, M.G.R. salai palavakam, Chennai-600041
Chennai
TAMIL NADU 
9841294757

rajsachin1994@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  salivary streptococcus mutans colony count 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  Silver Diamine Fluoride varnish  single time application of silver diamine fluoride varnish then evaluate streptococcus mutans colony count and patients satisfaction level after 7 days  
Intervention  Silver Diamine Fluoride with Potassium Iodide varnish  single time application of silver diamine fluoride with potassium iodide varnish application then evaluate streptococcus mutans colony count and patients satisfaction level after 7 dats  
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1-Geriatric age group people are included (above 60 years of age)
2-Subjects with a minimum of 20 teeth present in their oral cavity.
3-Subject having one or more root/root surfaces with caries that are not indicated for extraction. (Billings root surface caries index(1986)- Grade-â… , â…¡, â…¢)
4-Participants who give written informed consent before the commencement of the study.
 
 
ExclusionCriteria 
Details  •Participants with cognitive problems in communication and who can’t able to do their normal self-care activity are excluded.
•Participates with a known history of allergy to silver or any other metallic allergies.
•Participants have one or more root/root surfaces with caries which are indicated for pulpal therapy or extraction. (Billings root surface caries index(1986)- grade-Ⅳ)
•Participants reporting any acute conditions of the oral cavity requiring immediate attention are excluded.
•Participants whose salivary gland function had been significantly affected by the disease, medication, or treatment such as radiotherapy in the head and neck region are excluded.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
patients satisfaction level and streptococcus mutans colony count  at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
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   N/A 
Date of First Enrollment (India)   20/10/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Dental caries is a prevalent oral disease among elders worldwide. Epidemiological studies have shown that the incidence of root caries increases with age, and the prevalence of root caries in elders is high (1). In recent surveys in many countries, around half of community-dwelling elders had root caries experience (2). For elders living in long-term care facilities, the oral health situation is usually poorer, with very high levels of untreated dental caries (3). There is an urgent need to prevent root caries among elders, especially those who are institutionalized. Clinical studies on dental caries prevention have so far been focused on coronal caries in children and adolescents. Little is known regarding the effectiveness of various caries-preventive agents on root surface caries. The reported prevalence of dental caries in elders varies in different countries but a high proportion of the caries lesions being untreated active decay is common (4). Poor oral health knowledge, infrequent tooth brushing, and low utilization of dental care services among the elders are some possible explanations for the high proportion of untreated dental caries (4, 5).

Since advanced dental caries can cause pain, tooth loss, and impact on general health, there is a need to develop affordable and effective treatment approaches to manage the untreated root caries lesions on tooth surfaces in elderly people. Nonsurgical intervention for shallow dentin caries lesions has been advocated. The topical application of fluoride agents is conservative treatment and a potentially good alternative to the surgical approach. Fluorides have been proved to be the single most effective weapon in the still limited arsenal of anti-caries agents in the last 60 years. Studies also conclude that caries preventive effects of fluoride are almost exclusively topical. 

Silver diamine fluoride (SDF), Ag(NH3)2F, has been used to arrest caries since 1969. Silver diamine fluoride is effective in arresting dentin caries in primary teeth of young children and is recommended for preventing and arresting dental caries lesions (6).

The caries arrest activity of silver fluoride solutions occurs through a number of mechanisms including the fluoride enhancing mineral formation, hardening of the tooth surface, and the inhibition of the enzymes that break down tooth structure (matrix metalloproteinase inhibition). The silver and fluoride are normally carried in an alkaline solution and there are a number of different carriers that have been used. The main disadvantage of treatment with Silver Fluoride solution is that the cavitated carious lesions become a darker color. This can result in poor aesthetics that could potentially be stigmatizing or unacceptable to children and their families. For that reason, it is important to explore ways in which clinicians can achieve the most aesthetically favorable outcome (7). In 2005, G.M. knight introduced a new approach to overcome the problem of SDF staining by applying a saturated solution of potassium iodide (KI) immediately after SDF application to reduce the staining of silver particles (8).

Based on this, the present study is designed to evaluate patient’s satisfaction level, and Streptococcus mutans colony count following a single application of SDF with and without KI among community-dwelling geriatric population in Chennai city.

 
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