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Application of Digital Impression Technology in Children's Dental Trauma

Primary Purpose

Dental Trauma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
digital impression
alginate impression
Sponsored by
The Dental Hospital of Zhejiang University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Trauma focused on measuring Immature permanent teeth ;Dental Trauma;Digital impressions

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Stomatology Hospital, Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

digital impression module

ordinary impression group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 12, 2022
Last Updated
June 12, 2022
Sponsor
The Dental Hospital of Zhejiang University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05420571
Brief Title
Application of Digital Impression Technology in Children's Dental Trauma
Official Title
Application of Digital Impression Technology in Children's Dental Trauma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2022 (Actual)
Primary Completion Date
January 30, 2025 (Anticipated)
Study Completion Date
May 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Dental Hospital of Zhejiang University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Trauma
Keywords
Immature permanent teeth ;Dental Trauma;Digital impressions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
digital impression module
Arm Type
Experimental
Arm Description
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.
Arm Title
ordinary impression group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
digital impression
Intervention Description
3D printed models after digital impressions
Intervention Type
Procedure
Intervention Name(s)
alginate impression
Intervention Description
Alginate impressions after plaster model infusion to make models
Primary Outcome Measure Information:
Title
Fixed efficiency
Description
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
Time Frame
four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LinXian Fang, Master
Phone
13588452773
Ext
0571-87215529
Email
flxzju@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
JinJin Yu, Master
Phone
13588003034
Ext
0571-87215529
Email
m05yujinjin@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LinXian Fang, Master
Organizational Affiliation
The Stomatology Hospital, Zhejiang University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Stomatology Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linxian Fang, master

12. IPD Sharing Statement

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Application of Digital Impression Technology in Children's Dental Trauma

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