跳至主要内容
临床试验/CTRI/2025/07/091357
CTRI/2025/07/091357招募中4 期

Comparative evaluation of digital and conventional impression methods in pediatric patients: A randomized crossover trial

Dr Saumya Jose1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年8月18日最近更新:
适应症

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
To compare comfort between conventional and digital impression in children

研究概览

简要总结

In pediatric dentistry, dental impressions are fundamental for diagnostic assessment and treatment planning, particularly in managing the growing orthodontic needs of children. Conventional impressions often cause discomfort, gagging, TMJ pain and anxiety, making cooperation difficult. They also carry technical drawbacks such as distortion and long setting times. Digital impressions using intraoral scanners offer an alternative by generating 3D images of the dentition and reducing lab work. However, in children aged 7–14, factors like smaller oral cavities, mixed dentition, and limited access to posterior areas may affect their accuracy. Stress during dental procedures can lead to increased heart rate, rapid breathing, and reduced oxygen saturation—physiological changes influenced by anxiety and fear. While previous studies have focused on preferences and procedural time, few have assessed these objective stress indicators This study aims to bridge these gaps by comprehensively comparing digital and conventional providing clinically relevant insights to enhance pediatric dental care A randomized crossover study will be conducted on 40 participants, each receiving both conventional and digital impressions, with a one week washout period between procedures. Block randomization will determine the order of procedures, with allocations concealed in sealed, opaque envelopes which will be opened at the time of impression. Conventional Alginate impressions of upper arch will be taken using hand-mixed alginate and poured with type III gypsum. Digital impressions of upper arch will be recorded using an intraoral scanner following manufacturer guidelines. Chairside time will be recorded for each method. Physiological responses—pulse rate and oxygen saturation—will be recorded before, during, and after each procedure using a wireless pulse oximeter. Maxillary arch distances will be conducted using vernier calipers on the cast poured from the alginate impression and digitally in the intraoral scanner via the software ruler, with specific reference points. After both sessions, patient preference will be recorded, and subjective feedback on pain, gag reflex, breathing difficulty, and comfort will be assessed using the Wong-Baker FACES® Scale. The results will be tabulated and statistically analysed

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
7.00 Year(s) 至 14.00 Year(s)(—)
性别
All

入选标准

  • A healthy child with no significant medical history
  • Child aged 7-14 years
  • Patients with fully erupted maxillary permanent first molars and presence of maxillary canines which are caries free, not restored and without any anomalies.
  • Patients with no previous experience with digital intraoral scan or alginate impression technique
  • Patients in need of treatment with removable orthodontic appliances
  • Patients in need of dental treatment, excluding fixed orthodontic appliance therapy
  • Children whose parents or guardians gave consent.

排除标准

  • Non-compliant patients
  • Patients with syndromes or systemic diseases
  • Patients with fixed appliance
  • Children whose parents or guardians did not give consent.

结局指标

主要结局

To compare comfort between conventional and digital impression in children

时间窗: At baseline and at 2 weeks

次要结局

  • To compare physiologic response between conventional & digital(impression in children)
  • To compare accuracy in conventional & digital impression in children(1. At baseline)
  • To compare time taken for conventional & digital impression in(children)
  • To compare preference between conventional & digital impression(in children)

研究者

发起方
Dr Saumya Jose
申办方类型
Other []
责任方
Principal Investigator
主要研究者

Dr Saumya Jose

Christian Dental College

研究点 (1)

Loading locations...

相似试验