| CTRI Number |
CTRI/2025/02/080853 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
15/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Insights into Physiological and Emotional Impacts of Preschool Dental Interventions. |
|
Scientific Title of Study
|
Comparative Insights into Physiological and Emotional Impacts
of Preschool Dental Interventions: Sealants Versus Varnish"
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arunima Sarkar |
| Designation |
POST GRADUTE |
| Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences Uttar Pradesh |
| Address |
SPPGIDMS,Chaudhary Vihar, Utrathia, Raebareily Road Lucknow – 226029 – Uttar Pradesh
Lucknow UTTAR PRADESH 226029 India |
| Phone |
09001713480 |
| Fax |
|
| Email |
arunimasarkar08@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sonali Saha |
| Designation |
Professor and Director |
| Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences Uttar Pradesh |
| Address |
SPPGIDMS,Chaudhary Vihar, Utrathia, Raebareily Road Lucknow – 226029 – Uttar Pradesh
Lucknow UTTAR PRADESH 226029 India |
| Phone |
9889234995 |
| Fax |
|
| Email |
drsonalisaha24@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sonali Saha |
| Designation |
Professor and Director |
| Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences Uttar Pradesh |
| Address |
SPPGIDMS,Chaudhary Vihar, Utrathia, Raebareily Road Lucknow – 226029 – Uttar Pradesh
UTTAR PRADESH 226029 India |
| Phone |
9889234995 |
| Fax |
|
| Email |
drsonalisaha24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sardar Patel Post Graduate Institute Of Medical and Dental Sciences, Lucknow
India, 226002 |
|
|
Primary Sponsor
|
| Name |
DrArunima Sarkar |
| Address |
SPPGIDMS,Chaudhary Vihar, Utrathia, Raebareily Road Lucknow – 226029 – Uttar Pradesh |
| 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 |
| DrArunima Sarkar |
Sardar Patel Postgraduate Institute of Dental and Medical Sciences , Lucknow |
Room no 05 ,3rd floor, Department Of Pediatric and Preventive Dentistry, SPPGIDMS,Chaudhary Vihar, Utrathia, Raebareily Road Lucknow – 226029 – Uttar Pradesh Lucknow UTTAR PRADESH |
09001713480
arunimasarkar08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Glass Ionomer Sealant (GIS)
|
The intervention will be provided by the Principal Investigator. GIS will be applied using the finger pressure technique outlined in the WHO manual for atraumatic restorative treatment. The primary second molars will be first cleaned and dried with gauze and afterwards, GC cavity conditioner (10% poly acrylic acid) will be applied with a micro-brush for 10–15 s and subsequently cleaned with wet cotton pellets. Then we will mix a capsule of standardised liquid–powder ratio GIC (GC Fuji VII, GC Asia) with the amalgamator and the operator will apply the material on the occlusal surface using a plastic instrument. A gloved finger with petroleum jelly (Vaseline) will be used to rub the GIC into the pits and fissures. Subsequently, excess material will be removed using a hand excavator. |
| Comparator Agent |
NIL |
NIL |
| Comparator Agent |
Sodium Fluoride Varnish (NAFV) |
The operator will follow a standard technique and a protocol for each subject. For the NaFV group, the primary second molars will be first cleaned and dried with gauze and afterwards, the operator will place 0.25 ml of varnish (Colgate Duraphat varnish, Colgate-Palmolive UK Ltd) in the plastic dappen dish. A micro-brush will be used to apply the varnish onto the second primary molars and the rest of the dentition. The child will be instructed not to eat or drink for at least half an hour after the application. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Overall tooth status assessment with diagnostic criteria and dental caries status cased on ICDAS code score, children considered to be moderate to high caries risk according to the criteria (“Guideline on Caries-risk Assessment and Management for Infants, Children, and Adolescents,†2016) outlined by the American Academy of Paediatric Dentistry (AAPD) will be included.
Children snacking more than 3 times a day.
Children who are put to sleep with a bottle containing natural or added sugar.
Children having decayed-missing filled surfaces score of more than 1, having enamel defects.
|
|
| ExclusionCriteria |
| Details |
Children with serious systemic diseases requiring long-term medication or special needs will be excluded.
Children who will be uncooperative during the procedure.
Children who have received professional topical fluoride treatment in the past 6 months will be excluded.
Children with primary second molars that are partially erupted, with enamel defects or with sealants, restorations or dentinal caries indicated by ICDAS scores 4, 5, and 6 will be excluded.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome for the study will be to access the dental anxiety , pain perception and parental style assessment in pre -school children during intervention with varnish and sealant. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="82" Sample Size from India="82"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
22/02/2025 |
| Date of Study Completion (India) |
04/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="2" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
PUBLISHED |
|
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 multifactorial and dynamic disease that results in the
demineralization of dental hard tissues1. The prevalence of early
childhood caries (ECC), especially in young children, is high, ranging from 12
to 98% in 4-year-old children in different countries1. Considering
the high prevalence of active and untreated decay in young children, the
importance of secondary prevention must not be underestimated. Secondary
prevention comprises preventing the progression of the disease and stimulating the
remineralization of initial lesions1. Fundamental cornerstones to
secondary prevention include professional topical fluoride application and
sealing occlusal surfaces of molars to arrest caries progression.2,3
Fissure sealants could penetrate susceptible surfaces of teeth to
physically prevent food trapping and biofilm stagnation which may induce caries
progression2. Another systematic review also identified 5% sodium
fluoride varnish as the most efficacious for arresting or reversing
non-cavitated smooth surface lesions amongst other non-restorative treatments
for dental caries.4 Considering the efficacy of both modalities,
existing research has found no significant differences in effectiveness between
fluoride varnish and fissure sealant in preventing the progression of dental
caries in both primary and permanent dentitions.5,6
When providing the above-mentioned treatments to the paediatric
population, we must consider that dental clinics may be linked with fear-provoking
procedures that involve the use of painful needles, local anaesthesia, drills
and vibratory sounds. The assumptions of these painful conditions cause fear
and anxiety in anticipation of threatening stimuli. Anxiety in the dental
setting is multifactorial in origin, that may be attributed to individual
personality characteristics, self-consciousness, fear of the unknown, poor
understanding, and coping mechanisms. There is a strong relationship between
dental anxiety and successful dental treatment.7
Dental anxiety is therefore defined as the distressed expectation of a
visit to a dentist to the extent that a child might avoid treatment, while
dental fear/phobia is defined as when the distressed expectation interferes
with normal functioning.7 Hence, considering the conjoining impact
of DA and ECC, it is important for paediatric dentists to investigate which
treatment modalities evoke less anxiety, and less pain and promote
cooperativeness so that treatment can be delivered smoothly and safely.
Furthermore, clinicians may gain insights into providing a favourable
experience and building a positive attitude towards dental treatment for the
patient in the long run.7
Dental Anxiety can be assessed through self-assessment anxiety scales
but It is still considered a difficult measurement as it is a subjective issue
that may vary among individuals. For a more accurate assessment, anxiety can
also be assessed through the physiological response of the body that occurs due
to stress with evidence of positive correlation with moderate-to-severe dental
anxiety. Stress/anxiety can alter physiologic functions like increased
cortisol, rapid breathing tachycardia and trembling, and changes in the blood
pressure, pulse rate and respiratory rate which in time may alter oxygen
saturation and or carbon dioxide levels in the blood resulting in hypoxia.8
Pulse is part of the work
system of the heart, thus in a state of heart pounding in the theory put
forward by psychologists is one manifestation of physical symptoms in the physiological
level of anxiety. The average pulse rate of a child is 80-100 times per minute
with a faster rate if someone is anxious or afraid.7
Blood oxygen saturation as measured by the pulse oximeter has been
regarded as the fifth vital sign essential for efficient patient monitoring
during medical and dental procedures. Pulse oximetry (PO) is a non-invasive
method of measuring peripheral oxygen saturation (SpO2) based on the
differential absorption of red versus infrared light by oxygenated haemoglobin
in a narrow tissue segment like the hand or foot. It is recorded as SpO2, with
a normal range of 95-100%. Hypoxemia is usually defined as SpO2 less than 90% which
usually does not occur with normal physiological conditions.7
Also, the patient-practitioner interrelationship is more complicated
patient parent parent-dentist interaction in pediatric dentistry. Pediatric behaviour
guidance styles often have to be varied to accommodate the special needs of
different children. While one method of behavior guidance may be effective when
interacting with one group of children it may be inappropriate when dealing
with another. A child’s behaviour towards adults varies according to different
parenting styles and continues in the dental office in interactions with the
dentist. Parenting style may be
considered an essential determinant of children’s coping styles. The way a
child has been brought up has a great influence on its behaviour in later
years, particularly behaviour and interactions in social contexts.9
Various parenting styles have
been studied previously. Baumrind’s authoritarian, permissive, and
authoritative styles are often investigated in studies of parenting styles
in relation to such diverse child outcome variables as academic achievement,
self-confidence, aggression, delinquent behaviour and substance abuse. Authoritative
parenting is defined as a style that utilizes warmth and nurturance, while at
the same time maintaining firm control of the child’s behaviour. The
authoritarian category is defined as a harsh parenting style in which
power-assertive techniques are utilized, including physical punishment,
commands and yelling, while lacking warmth and communication. Permissive parents are characterized as
having little control over their children while exhibiting great warmth toward
them. A fourth parenting style, called neglectful, is characterized by low
warmth and low control.9
Hence, this present study will be undertaken to
compare dental anxiety, pain associated, parenting style, physiological
parameters and application time during intervention using fissure sealant vs
topical fluoride varnish in preschool children. |