The Influence of Complex Correction of Dental and Musculo... | NCT06263504

Studies
The Influence of Complex Correction of Dental and Musculoskeletal Systems on the Frequency of Relapses of Functional Disorders in Patients With Dental Pathologies.

NCT06263504

Sponsor

NMSI DENTMASTER

Status

Unknown status

Last Update Posted

Feb 26, 2024Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Malocclusion
Musculoskeletal Disorder

Interventions

at correcting malocclusions or restoring the integrity of the dentition
comprehensive treatment, including not only dental correction of bite or restoration of the integrity of the dentition, but also correction of disorders of the musculoskeletal system.

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

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2024Estimated

Primary Completion Date

Jun 15, 2025Estimated

Completion Date

Oct 15, 2025Estimated

First Submitted Date

Feb 8, 2024

First Submission Date that Met QC Criteria

Feb 8, 2024

First Posted Date

Feb 16, 2024Actual

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

Feb 22, 2024

Last Update Posted Date

Feb 26, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

In influence of complex correction of dental and musculoskeletal systems on the frequency of relapses of functional disorders in patients with somatic pathologies: a randomized pilot study there will be two groups: Group 1 (control group): Patients in this group will receive standard treatment aimed solely at correcting malocclusions or restoring the integrity of the dentition without interfering with the musculoskeletal system.

Group 2 (experimental group): Patients will receive comprehensive treatment, including not only dental correction of bite or restoration of the integrity of the dentition, but also correction of disorders of the musculoskeletal system.

The endpoints will be :

Primary endpoint:

• Frequency of relapses and repeated requests for correction of disorders bite or restoration of the integrity of the dentition within 12 months after treatment.

Secondary endpoints:

Change in pain intensity measured by visual analog scale (VAS).
Improvement of functional indicators of the temporomandibular joint, including range of motion.
Improved quality of life, assessed using the OHRQoL (Oral Health Related Quality) scale All endpoints will be evaluated within 12 months.

Detailed Description

Not provided

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

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
receive standard treatment group	Active Comparator		Procedure: at correcting malocclusions or restoring the integrity of the dentition
comprehensive treatment group	Experimental		Procedure: comprehensive treatment, including not only dental correction of bite or restoration of the integrity of the dentition, but also correction of disorders of the musculoskeletal system.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
at correcting malocclusions or restoring the integrity of the dentition	Procedure	Patients in this group will receive standard treatment aimed solely at correcting malocclusions or restoring the integrity of the dentition without interfering with the musculoskeletal system.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of relapses and repeated requests for correction of disorders bite or restoration of the integrity of the dentition.		12 months

Secondary Outcomes

Measure	Description	Time Frame
Change in pain intensity measured by visual analog scale (VAS).	A Visual Analogue Scale - VAS Purpose: pain intensity assessments Interpretation: 0 points - no violations; 1-3 points - mild pain (mild impairment); 4-6 points - moderate pain (moderate impairment); 7-8 points - severe pain (severe impairment); 9-10 points - unbearable pain (absolute violations).	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed malocclusion or dentition insufficiency, confirmed by a dentist.
- Presence of diseases of the musculoskeletal system, confirmed orthopedist or rheumatologist.
- Acquired limb deformities (for example, flat feet, valgus or varus deformity).
- Deforming dorsopathies (kyphosis, lordosis, scoliosis, osteochondrosis).
- Consent to participate in the study and follow the treatment protocol.
- Sufficient general physical and mental fitness to participate in the study

Exclusion Criteria:

Systemic diseases affecting bone metabolism (eg osteoporosis).
- Progressive neurological diseases.
- Current treatment with steroids or immunosuppressive drugs.
- Presence of malignant neoplasms.
- Psychiatric disorders that prevent compliance protocol.
- Pregnancy or lactation period.
- Carrying out dental or orthopedic treatment in recent 6 months.
- Skeletal malocclusions.
- Diseases of the temporomandibular joint.
- Congenital pathologies of the musculoskeletal system.
- Arthropathy.
- Systemic connective tissue diseases.
- Biomechanical lesions of the musculoskeletal system.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Olga A Belasik	Contact	9137173754	+7	olga_belasik@mail.ru
Tatiana A Gatilova	Contact	9529399919	+7	gatilova@dentservice.ru

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nmsi Dentmaster		Novosibirsk	Novosibirsk Oblast	630090	Russia

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D008310	Malocclusion
D009140	Musculoskeletal Diseases

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases