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

Malocclusion Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06263504
• Other study ID #: DM001
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 10, 2024
• Est. completion date: October 15, 2025

Study information

• Verified date: February 2024
• Source: NMSI DENTMASTER
• Contact: Olga A Belasik
• Phone: 9137173754
• Email: olga_belasik[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: October 15, 2025
• Est. primary completion date: June 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malocclusion
• Musculoskeletal Diseases
• Musculoskeletal Disorder

Intervention

Procedure:
• at 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.
• 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.
): 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.

Locations

Country	Name	City	State
Russian Federation	Nmsi Dentmaster	Novosibirsk	Novosibirsk Region

Sponsors (1)

Lead Sponsor	Collaborator
NMSI DENTMASTER

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of relapses and repeated requests for correction of disorders bite or restoration of the integrity of the dentition.		12 months
Secondary	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
Secondary	Changes in functional parameters of the temporomandibular joint, including range of motion. joint, including range of motion.	0- No changes; The changes are positive; Changes are negative	12 month
Secondary	Improved quality of life, assessed using the OHRQoL (Oral Health Related Quality) scale	Change 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	12 month