| CTRI Number |
CTRI/2024/08/072862 [Registered on: 21/08/2024] Trial Registered Prospectively |
| Last Modified On: |
20/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [ALTERNATIVE RESTORATIVE PROCEDURE V] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Assess the Effectiveness of Silver Diamine Fluoride with Glass Ionomer Cement in Differently Abled Children |
|
Scientific Title of Study
|
To assess the effectiveness of silver diamine fluoride application with delayed glass ionomer cement restoration in dentinal caries of differently abled children An in-vivo 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 Shashwath K |
| Designation |
Post Graduate |
| Affiliation |
Coorg Institute of Dental Sciences |
| Address |
Department of Pediatric and Preventive Dentistry Room No 8 Coorg Institute of Dental Sciences Kanjithanda Kushalappa Campus Maggula Virajpet Kodagu
Kodagu KARNATAKA 571218 India |
| Phone |
8762118374 |
| Fax |
|
| Email |
shashwathk1997@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shanthala B M |
| Designation |
Professor and Head |
| Affiliation |
Coorg Institute of Dental Sciences |
| Address |
Department of Pediatric and Preventive Dentistry Room No 8 Coorg Institute of Dental Sciences Kanjithanda Kushalappa Campus Maggula Virajpet Kodagu
Kodagu KARNATAKA 571218 India |
| Phone |
9901452918 |
| Fax |
|
| Email |
shanthalapedo@cids.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Shashwath K |
| Designation |
Post Graduate |
| Affiliation |
Coorg Institute of Dental Sciences |
| Address |
Department of Pediatric and Preventive Dentistry Room No 8 Coorg Institute of Dental Sciences Kanjithanda Kushalappa Campus, Maggula Virajpet Kodagu
Kodagu KARNATAKA 571218 India |
| Phone |
8762118374 |
| Fax |
|
| Email |
shashwathk1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Coorg Institute of Dental Sciences Kanjithanda Kushalappa Campus, Maggula Virajpet Kodagu District Karnataka 571218 |
|
|
Primary Sponsor
|
| Name |
Dr Shashwath K |
| Address |
Department of Pediatric and Preventive Dentistry Room No 8 Coorg Institute of Dental Sciences Kanjithanda Kushalappa Campus, Maggula Virajpet Kodagu District Karnataka 571218 |
| 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 |
| Dr Akshatha S |
Coorg Institute of Dental Sciences |
Department of Pediatric and Preventive Dentistry Room No 8 Coorg Institute of Dental Sciences Kanjithanda Kushalappa Campus, Maggula Virajpet Kodagu District Karnataka 571218 Kodagu KARNATAKA |
7975149377
shivaakshatha3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD COORG INSTITUTE OF DENTAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
SPECIAL CHILDREN |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Silver Diamine Fluoride |
Silver Diamine Fluoride used to arrest the caries process in a tooth over a period of time. In this study restoration is followed after 2 weeks of Intervention applied.
Hence Comparator agent is not applicable . |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1.Differently abled children
2.Age between 3 -14 years will be selected
3. Selected subject should have dentinal caries involving either Primarymolars /Premolar/Permanent molars belonging to ICDAS score 4 and 5
|
|
| ExclusionCriteria |
| Details |
1.Enamel caries and caries involving pulp
2.Systemically healthy children with no physical and mental disabilities
3.Differently abled children less than 3 years and above 14 years.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Arrest of Progression of Caries |
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| As a Control of Dental Caries Consequences in the Tooth |
3 Years |
|
|
Target Sample Size
|
Total Sample Size="72" Sample Size from India="72"
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 4 |
|
Date of First Enrollment (India)
|
02/09/2024 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response (Others) - For continuing Research
- By what mechanism will data be made available?
Response (Others) - Through publication in the scientific journal as manuscript
- For how long will this data be available start date provided 27-07-2024 and end date provided 27-07-2041?
Response (Others) - Indefinitely
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
| Dental caries continues to be one of the most prevalent chronic diseases in the world, affecting people across all age groups and countries . The oral health of differently abled children may be affected due to untreated dental conditions resulting from inadequate diagnosis or limited access to dental services . It’s acknowledged that differently abled children encounter distinct obstacles when pursuing preventive and restorative dental care . The presence of intricate physical and medical conditions, coupled with behavioural challenges, can complicate the process of diagnosis and treatment. Consequently, parents or caregivers face increased difficulty in fulfilling their role in providing daily preventive care . The association between fluoride and dental practice, as well as preventive dentistry, spans over two centuries, as evidenced by historical documents indicating a potential correlation between fluoride and caries . Future studies are directed towards enhancing the antimicrobial and anti-degradative characteristics of existing restoration materials by modifying their composition, with the goal of minimizing microbial adherence and biofilm formation . Silver diamine fluoride, a solution comprising silver nitrate and fluoride, serves as both an antibacterial and remineralizing agent. By diminishing biofilm counts and impeding collagen degradation, the product promotes the remineralization of enamel and dentin, effectively halting the advancement of caries . Silver diamine fluoride (SDF) plays a crucial role in caries management, particularly for children at high risk of caries, individuals with medical complexities, those facing behavioural challenges, and those encountering barriers to accessing dental care . The mechanism of action of SDF relies in its ability to react with hydroxyapatite to generate fluorapatite, which prevents or lessens any future caries. When SDF is administered, it penetrates both the enamel and dentin, stocking the tooth with nearly twice as much subsurface fluoride as other fluoride forms . However, the primary drawback of SDF lies in its tendency to stain caries lesions, primarily attributable to the silver compounds present in the solution. This staining effect has contributed to the limited acceptance of SDF within the dental community . The success and durability of dental restorations rely on various critical factors. Among them, establishing a robust bond between the restorative material and the tooth substrate is vital, encompassing not only mechanical considerations but also biological and aesthetic aspects . Chemical bonding to both enamel and dentin distinguishes glass ionomer cements (GICs) from others, by interactions involving hydroxyapatite and polycarboxylate radicals . Applying GIC immediately following SDF application results in tooth discoloration, whereas delaying GIC restoration for two weeks after SDF application minimizes discoloration . This study aims at assessing the effectiveness of SDF and GIC restoration in dentinal caries in differently abled children. | |