Clinical trial NCT06263504: The Influence of Complex Correction of Dental and Musculoskeletal Systems on the Frequency of Relapses of Functional Disorders in Patients With Dental Pathologies.
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Malocclusion
Musculoskeletal Disorder
Keywords: Malocclusion
Musculoskeletal Disorders
orthodontics
dental prosthetics
complex correction of the dental system
Lead sponsor: NMSI DENTMASTER
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Frequency of relapses and repeated requests for correction of disorders bite or restoration of the integrity of the dentition.
timeFrame: 12 months
Secondary outcomes:
measure: Change in pain intensity measured by visual analog scale (VAS).
timeFrame: 12 months
measure: Changes in functional parameters of the temporomandibular joint, including range of motion. joint, including range of motion.
timeFrame: 12 month
measure: Improved quality of life, assessed using the OHRQoL (Oral Health Related Quality) scale
timeFrame: 12 month
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Nmsi Dentmaster
state: Novosibirsk Region
Study officials:
References: