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临床试验/CTRI/2025/02/080853
CTRI/2025/02/080853已完成Phase 3 4

Comparative Insights into Physiological and Emotional Impacts of Preschool Dental Interventions: Sealants Versus Varnish"

DrArunima Sarkar1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2025年2月22日最近更新:

试验速览

阶段
Phase 3 4
状态
已完成
发起方
入组人数
82
试验地点
1
主要终点
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.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
3.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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.

时间窗: Baseline

次要结局

未报告次要终点

研究者

发起方
DrArunima Sarkar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Arunima Sarkar

Sardar Patel Post Graduate Institute of Dental and Medical Sciences Uttar Pradesh

研究点 (1)

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