| CTRI Number |
CTRI/2023/09/057884 [Registered on: 20/09/2023] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative evaluation of two protocols to prevent dental caries in special children |
|
Scientific Title of Study
|
Efficacy of silver diamine fluoride versus silver diamine fluoride & fluoride varnish in arresting dental caries in special children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sukhdeep Singh |
| Designation |
Professor |
| Affiliation |
School of dental sciences, Sharda University |
| Address |
Head, Dept. of Pediatric and preventive dentistry, School of dental sciences, Sharda University
Gautam Buddha Nagar UTTAR PRADESH 201306 India |
| Phone |
9971808787 |
| Fax |
|
| Email |
sukhdeep.singh@sharda.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Sukhdeep Singh |
| Designation |
Professor |
| Affiliation |
School of dental sciences, Sharda University |
| Address |
Head, Dept. of Pediatric and preventive dentistry, School of dental sciences, Sharda University
UTTAR PRADESH 201306 India |
| Phone |
9971808787 |
| Fax |
|
| Email |
sukhdeep.singh@sharda.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Sukhdeep Singh |
| Designation |
Professor |
| Affiliation |
School of dental sciences, Sharda University |
| Address |
Head, Dept. of Pediatric and preventive dentistry, School of dental sciences, Sharda University
UTTAR PRADESH 201306 India |
| Phone |
9971808787 |
| Fax |
|
| Email |
sukhdeep.singh@sharda.ac.in |
|
|
Source of Monetary or Material Support
|
| School of dental sciences, Sharda University |
|
|
Primary Sponsor
|
| Name |
School of dental sciences, Sharda University |
| Address |
Plot 32-34, Knowledge Park-3, Greater Noida-201306, U.P. |
| Type of Sponsor |
Other [Private dental college and hospital] |
|
|
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 |
| Sukhdeep Singh |
School of dental sciences |
Sharda University, Plot 32-34, Knowledge park-3, Greater Noida-201306 Gautam Buddha Nagar UTTAR PRADESH |
9971808787
sukhdeep.singh@sharda.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, School of medical sciences and research and Sharda hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
38% Silver diamine fluoride and 2% fluoride varnish |
38% Silver diamine fluoride (SDF)will be topically applied on the decayed teeth as per manufacturers instructions followed by the topical application of 2% sodium fluoride NaF on the entire dentition. |
| Intervention |
Fluoride varnish |
2% Sodium fluoride NaF varnish meant for topical use in dentistry will be applied on all the teeth of the child as per manufacurers instructions. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Special children aged 4 years to 14 years with dental decay will be selected |
|
| ExclusionCriteria |
| Details |
Special children below 4years and above 14 years and those with no dental decay will be excluded |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical evidence of dental decay arrest. Conversion of Nyvad scale 1, 2, and 3 to 4, 5, 6. |
Clinical evidence of dental decay arrest. Conversion of Nyvad scale 1, 2, and 3 to 4, 5, 6. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical evidence of non arrest of dental decay. Any clinical evidence of worsening of the existing dental decay in terms of pain/abcess |
6 months, 12 months, 18 months. |
|
|
Target Sample Size
|
Total Sample Size="110" Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/09/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="9" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Dental caries has been
around for time immemorial. It is a microbial infectious disease and probably
the most significant chronic childhood disease prevalent globally. It can lead
to a high level of morbidity and affect the quality of life in many ways. It is
a secular infectious disease cutting across all sections of society in both
developed and developing nations. Some of the consequences of untreated lesions
are pain, swelling, fever, inability to eat, malnutrition, difficulty in speech
and tooth loss.
A lot has changed in
the recent past in understanding the science of dental caries, its prevention
and treatment but data from across the world shows that dental caries remains a
serious disease globally.
The level of awareness
in caregivers (parents and non dental healthcare providers) regarding the
symptoms, treatment (especially of untreated lesions) and prevention of dental
caries remains low. This leads to a huge burden of care on the society.
Special health care
needs children are at a much higher risk of developing dental caries because of
their inherent challenges of carrying our even simple acts like tooth brushing.
Added to this is also the fact that most of the parents of special children may
be focused on seeking and providing seemingly more important medical care to
their child/children which leads to a neglect of dental care. Medical care in
special children may also involve administering medications in a sweetened
syrup form which are mostly sugar based. Lack of awareness regarding caries
prevention amongst parents leads to dental caries in such children. Special
children are often on pureed diets which are more cariogenic and need special
preventive protocols often found missing. Added to these is the fact that
special children need a different approach for their dental treatment and hence
not all dentists are able to competently treat special children. More often
than not this also entails higher treatment costs which become a constraint for
many parents leading to a neglect of dental caries. This may become a vicious
cycle and end in serious morbidity and tooth loss.
Over time numerous
preventive strategies and protocols have been tried and tested by the dental
fraternity of researchers and clinicians. Literature is replete with many
examples and two stand out in recent times. These are topical application of
fluoride varnish (FV) and silver diamine fluoride (SDF). Many studies have been
conducted on both the protocols and there are meta analysis and systematic
reviews too, explaining the evidence on their efficacy. Both protocols work.
Traditionally fluoride varnish has been
extensively used in the prevention of dental caries. SDF has proven itself to
be a effective measure in arresting decay, hence the interest in its use in
special children. Very few relevant studies exist in the literature where in
SDF has been studied in special children, either alone or with fluoride
varnish. This trial will try and bridge this gap.
|