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

NCT06263504 | Not Yet Recruiting

• 1 other identifier: DM001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Malocclusion; Musculoskeletal Disorder

Keywords

Malocclusion; Musculoskeletal Disorders; orthodontics; dental prosthetics; complex correction of the dental system

Outcome Measures

Primary Outcomes (1)

• Frequency of relapses and repeated requests for correction of disorders bite or restoration of the integrity of the dentition.

  12 months

Secondary Outcomes (3)

• Change in pain intensity measured by visual analog scale (VAS).

  12 months

• Changes in functional parameters of the temporomandibular joint, including range of motion. joint, including range of motion.

  12 month

• Improved quality of life, assessed using the OHRQoL (Oral Health Related Quality) scale

  12 month

Study Arms (2)

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

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.

receive standard treatment group

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. PROCEDURE

): 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.

comprehensive treatment group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NMSI DENTMASTER: lead

Study Sites (1)

Nmsi Dentmaster

Novosibirsk, Novosibirsk Oblast, 630090, Russia

Location

MeSH Terms

Conditions

Malocclusion; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Olga A Belasik

CONTACT

9137173754; olga_belasik@mail.ru

Tatiana A Gatilova

CONTACT

9529399919; gatilova@dentservice.ru

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: February 8, 2024
• First Posted: February 16, 2024
• Study Start: March 10, 2024
• Primary Completion: June 15, 2025
• Study Completion: October 15, 2025
• Last Updated: February 26, 2024

Record last verified: 2024-02

Locations

RU (1)