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

The Influence of Complex Correction of Dental and Musculoskeletal Systems on the Frequency of Relapses of Functional Disorders in Patients With Dental Pathologies: a Randomized Pilot Clinical Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06263504
Enrollment
40
Registered
2024-02-16
Start date
2024-03-10
Completion date
2025-10-15
Last updated
2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malocclusion, Musculoskeletal Disorder

Keywords

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

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.

Interventions

PROCEDUREat correcting malocclusions or restoring the integrity of the dentition

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.

PROCEDUREcomprehensive 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.

): 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.

Sponsors

NMSI DENTMASTER
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Frequency of relapses and repeated requests for correction of disorders bite or restoration of the integrity of the dentition.12 months

Secondary

MeasureTime frameDescription
Change in pain intensity measured by visual analog scale (VAS).12 monthsA 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).
Changes in functional parameters of the temporomandibular joint, including range of motion. joint, including range of motion.12 month0- No changes 1. The changes are positive 2. Changes are negative
Improved quality of life, assessed using the OHRQoL (Oral Health Related Quality) scale12 monthChange in quality of life, assessed by the OHRQoL-Oral Health Related Quality of Life scale. Index of the impact of oral health on quality of life (OHIP - Oral Health Impact Profile). The Oral Health Impact Index (OHIP) includes 49 questions covering 7 dimensions: functional limitation, physical pain, psychological discomfort, physical, psychological, social discomfort and lack of confidence. Scores for each question range from 0 (never) to 4 (always), meaning the maximum possible total score is 196. The minimum score, 0, indicates no impact of oral health problems on quality of life. The higher the score, the greater the impact on quality of life the patient experiences

Countries

Russia

Contacts

Primary ContactOlga A Belasik
olga_belasik@mail.ru9137173754
Backup ContactTatiana A Gatilova
gatilova@dentservice.ru9529399919

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026