NCT05727670

Brief Summary

The relevance of the research topic is beyond doubt, since this work is devoted to improving the effectiveness of treatment of patients with permanent teeth that have not erupted in a timely manner. Currently, this pathology occurs in 4-18% of patients seeking specialized help in a dental clinic. The anomaly of teething, first of all, affects the anatomical, functional and aesthetic characteristics, there is an influence on the psycho-emotional state of the patient. Despite a significant number of scientific studies by domestic and foreign authors, some features of the treatment of patients with dental retention are insufficiently covered and systematized. At the moment, there is no optimal approach to the diagnosis and treatment of dental retention, as a result of which there is a question of improving the effectiveness and quality of orthodontic treatment of patients with a diagnosis of "tooth retention".

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

September 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 14, 2023

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 17, 2024

Status Verified

December 1, 2024

Enrollment Period

4 months

First QC Date

February 5, 2023

Last Update Submit

December 12, 2024

Conditions

Keywords

dental retentiondigital dentistrysurgical navigation template3D printing

Outcome Measures

Primary Outcomes (1)

  • treatment time

    acceleration of treatment terms

    two years

Study Arms (1)

main group

EXPERIMENTAL

This group consists of patients with dental retention who will be treated using digital technologies and devices to create a place in the dentition

Procedure: exposure of the tooth crown

Interventions

surgical exposure of the crown of a retentive tooth

main group

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Methodology

You may not qualify if:

  • patients without retentive teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Irina

Samara, Samara Oblast, 446185, Russia

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
development of a method for the treatment of extension of s with acceleration of treatment time
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: At the first stage of our study, it is planned to examine patients aged 15-35 years. The examination will be carried out according to the scheme including the main (clarification of complaints, anamnesis collection, external examination, examination of the oral cavity and teeth) and additional examination methods (anthropometric examination of diagnostic models of dentition, cone-beam computed tomography of the head, orthopantomography, telerentgenography of the head, electrodontodiagnostics, determination of the area of occlusal contacts). At the second stage of our study, it is planned to sample the results with the division of patients into the main and control groups. The main group will include patients who will receive orthodontic treatment according to the method we have proposed. The control group will include patients whose treatment will be carried out according to the standard method
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2023

First Posted

February 14, 2023

Study Start

September 1, 2022

Primary Completion

January 5, 2023

Study Completion

December 31, 2024

Last Updated

December 17, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

The orthodontic design developed by us will allow to create an additional place in the dentition with the subsequent extension of the retented tooth. The introduction into the clinical stage of the method we have developed for creating surgical access will facilitate the operation process and the number of complications.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
three years

Locations