Treatment of Retentive Teeth | NCT05727670

Studies
Treatment of Retentive Teeth

NCT05727670

Sponsor

Samara State Medical University

Status

Enrolling by invitation

Last Update Posted

Dec 17, 2024Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Treatment of Retentive Teeth

Interventions

exposure of the tooth crown

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2022Actual

Primary Completion Date

Jan 5, 2023Actual

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Feb 5, 2023

First Submission Date that Met QC Criteria

Feb 5, 2023

First Posted Date

Feb 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2024

Last Update Posted Date

Dec 17, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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".

Detailed Description

The purpose of the study Improving the effectiveness of treatment of patients with dental retention. Research objectives

To determine the frequency of occurrence of dental retention according to the patients' requests for orthodontic care;
Based on the cephalometric study to identify the features of the structure of the face and bone structures in patients with dental retention;
Develop and implement an orthodontic device to obtain additional space in the dentition in patients with retention;
To develop and introduce into clinical practice a method for creating surgical access to retentive teeth using digital technologies.
To conduct a comparative analysis of the effectiveness of our proposed improved stages of treatment of patients with dental retention with well-known methods based on gnatic and profilometric indicators.

Materials and methods of research At the first stage of our study, it is planned to examine patients aged 15-35 years who have applied for specialized

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
exposure of the tooth crown	Procedure	surgical exposure of the crown of a retentive tooth	main group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
treatment time	acceleration of treatment terms	two years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Methodology

Exclusion Criteria:

patients without retentive teeth

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

25 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Irina		Samara	Samara Oblast	446185	Russia

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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.

Types

Study Protocol
Clinical Study Report (CSR)

Time Frame

three years

Access Criteria

Not provided

URL

Not provided

Intervention Model Description

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

Masking Info

Masking

None (Open Label)

Masking Description

development of a method for the treatment of extension of s with acceleration of treatment time

Who Masked

Not provided