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临床试验/CTRI/2026/02/104966
CTRI/2026/02/104966招募中不适用

A Comparative Analysis of Staining Susceptibility: An In Vitro Study of Primary Teeth and Restorative Materials Exposed to Pediatric Medications

Sardar Patel Postgraduate Institute of Dental and Medical Sciences1 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2026年3月11日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
165
试验地点
1

研究概览

简要总结

1.****Background of StudyThe pursuit of optimal aesthetics in Pediatric Dentistry has become increasingly significant, as both children and their parents place a high value on the appearance of dental restorations. [1]A healthy, natural-looking smile not only contributes to a child’s self-esteem and social acceptance but also plays a crucial role in psychological and physiological development. [2,3]

The staining of the primary teeth is regarded as a common concern of parents since it can decrease social communications and the self-esteem of the children due to the dark, unaesthetic appearance of the teeth.[4] Consequently, restorative materials used in Pediatric Dentistry must not only restore function but also maintain their aesthetic appearance over time. Commonly used aesthetic restorative materials in Pediatric Dentistry include Composite resins, GICs, and Compomers.[5,6**]**Recent advancements have introduced             materials like Giomers, Alkasites, and Bioactive restoratives, which offer enhanced aesthetic and mechanical properties suitable for both deciduous and permanent teeth.[7,8]These materials aim to fulfil the increasing aesthetic demands while providing functional rehabilitation.

However, a persistent challenge remains: the colour stability of these materials over the lifespan of the restoration. Discolouration of restorative materials is influenced by intrinsic factors, such as the resin matrix composition, filler particle size, and degree of polymerization and extrinsic factors, including exposure to dietary substances, medications  and oral hygiene practices.[9,10] In pediatric patients, liquid medications, particularly antibiotics, iron supplements, multivitamins and cough syrup, are of notable concern due to their potential to cause discolouration of restorativematerials and teeth.[11,12**]** Therefore, it is necessary to assess and analyse the discolouration of various restorative materials and primary teeth caused by commonly prescribed pediatric medications.

研究设计

研究类型
Observational

入排标准

年龄范围
2.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Non-carious extracted or exfoliated primary teeth (molars or incisors) obtained ethically from patients undergoing planned dental extractions for reasons unrelated to pathology Teeth free from visible defects, including cracks, chips or previous restorations, to avoid variability in results caused by pre existing conditions.
  • Properly stored primary teeth in artificial saliva to maintain structural and colour integrity before experimental procedures.
  • Specimens stored at a controlled temperature (37 degree Celsius) in artificial saliva for polymerization and to simulate oral conditions.

排除标准

  • Teeth showing visible decay, fractures or discoloration as these factors may influence baseline colour and final outcomes.
  • Teeth with preexisting restorations or surface coatings, which could interfere with the experimental procedure.
  • Specimens exhibiting evidence of erosion, abrasion, or developmental defects such as enamel hypoplasia.
  • Specimens with air bubbles, incomplete polymerization or surface irregularities that could affect colour stability and measurement accuracy.
  • Disc specimens damaged during fabrication or storage.
  • Teeth improperly stored, leading to dehydration or contamination which could compromise the integrity of the enamel surface and baseline measurements.
  • Teeth exposed to substances or conditions outside the protocol such as accidental exposure to staining agents before experimentation.
  • Samples deviating significantly from standardized dimensions or preparation protocols, including inconsistent restorative material disc thickness or tooth window sizes.

研究者

发起方
Sardar Patel Postgraduate Institute of Dental and Medical Sciences
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr Ananya Srivastav

Sardar Patel Post Graduate Institute of Dental and Medical Sciences

研究点 (1)

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