Application of Digital Impression Technology in Children's Dental Trauma
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 30, 2022
CompletedFirst Submitted
Initial submission to the registry
June 12, 2022
CompletedFirst Posted
Study publicly available on registry
June 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2025
CompletedJune 15, 2022
May 1, 2022
2.7 years
June 12, 2022
June 12, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
digital impression module
EXPERIMENTALIn 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.
ordinary impression group
ACTIVE COMPARATORThe 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.
Interventions
Alginate impressions after plaster model infusion to make models
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Stomatology Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
Study Officials
- PRINCIPAL INVESTIGATOR
LinXian Fang, Master
The Stomatology Hospital, Zhejiang University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2022
First Posted
June 15, 2022
Study Start
May 30, 2022
Primary Completion
January 30, 2025
Study Completion
May 30, 2025
Last Updated
June 15, 2022
Record last verified: 2022-05