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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  
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 
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  
Status 
Not Applicable 
 
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.

 
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