Application of Digital Impression Technology in Children's Dental Trauma

We will Choose patients with tooth loosening caused by tooth trauma and requiring fix in the department of Pediatric Dentistry and emergency of Stomatology Hospital, Zhejiang University School of Medicine, from July 2022 to May 2025. These patients will be randomly divided into digital impression module (experimental group) and ordinary impression group (control group).The operation time, comfort index and efficacy index of the two groups were compared to investigate the advantages of digital impressions in the application of traumatic dental injuries in children.

Study Overview

• Status: Recruiting
• Conditions: Dental Trauma
• Intervention / Treatment: Procedure: digital impression; Procedure: alginate impression

Detailed Description

1. Information on medical history, physical examination, and ancillary tests were collected and recorded by the pediatric dentistry and emergency department to determine the inclusion subjects, and the grouping was determined according to a randomized controlled design.
2. In the experimental group, digital impressions + 3D printed models were used and fitted pads were made; in the control group, alginate impressions + plaster model infusion were used to make models and fitted pads were made. The included subjects were routinely examined intraorally before and after treatment. Patients were instructed to wear the hinge pad for 24 hours and X-ray films were taken and intraoral examination was performed at 2 weeks and 4 weeks.
3. The observation indexes included： (1) operation time: operation time for the child's chair position, (2) comfort index: pain assessment of patients using visual analog scale, (3) efficacy indexes: a. tooth sensitivity, gingival margin irritation, and lip irritation were assessed using visual analog scale (VSA); B. fixation efficiency.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: LinXian Fang, Master; Phone Number: 0571-87215529 13588452773; Email: flxzju@163.com
• Study Contact Backup: Name: JinJin Yu, Master; Phone Number: 0571-87215529 13588003034; Email: m05yujinjin@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The Stomatology Hospital, Zhejiang University School of Medicine
      • Contact: Linxian Fang, master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 6-12 years old ② Loosening or dislocation of anterior teeth caused by trauma; ③ Degree I, II and III of tooth mobility, excluding normal physiological mobility; ④ No jaw fracture, root fracture, avulsion injury and individual malocclusion; ⑤ Children can cooperate with treatment and follow up on time

Exclusion Criteria:

① Children have clear systemic disease factors (various syndromes, hormone level disorders, metabolic diseases, etc.); ② Patients with periodontal disease; ③ Children or family members do not agree to participate in the study; ④ Uncooperative or intolerable examination and treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: digital impression module; In the experimental group, digital impressions and 3D printed models were used and fitted pads were made. Patients were instructed to wear the hinge pad for 24 hours, and x-rays were taken and intraoral examinations were performed at 2 weeks and 4 weeks.	Procedure: digital impression; 3D printed models after digital impressions
Active Comparator: ordinary impression group; The control group used alginate impression and plaster model infusion to make the model and make the fitting pad. Patients were instructed to wear the pad for 24 hours, and x-rays and intraoral examinations were taken at 2 and 4 weeks.	Procedure: alginate impression; Alginate impressions after plaster model infusion to make models

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fixed efficiency	Fixed effective as the affected tooth loosening does not exceed the physiological degree of movement, X-ray examination periodontal membrane without widening without abnormal shadow of the root tip	four weeks

Collaborators and Investigators

• Sponsor: The Dental Hospital of Zhejiang University School of Medicine
• Investigators: Principal Investigator: LinXian Fang, Master, The Stomatology Hospital, Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2022
• Primary Completion (Anticipated): January 30, 2025
• Study Completion (Anticipated): May 30, 2025

Study Registration Dates

• First Submitted: June 12, 2022
• First Submitted That Met QC Criteria: June 12, 2022
• First Posted (Actual): June 15, 2022

Study Record Updates

• Last Update Posted (Actual): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 12, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Immature permanent teeth ；Dental Trauma；Digital impressions
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: DHZhejiangU-2022（59）

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No