| 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
|
|
|
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
|
|
|
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.
|
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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. |