protocolSection identificationModule nctId: NCT06263504, orgStudyIdInfo id: DM001, briefTitle: The Influence of Complex Correction of Dental and Musculoskeletal Systems on the Frequency of Relapses of Functional Disorders in Patients With Dental Pathologies., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2025-06-15, completionDateStruct date: 2025-10-15, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: NMSI DENTMASTER, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Malocclusion, conditions: Musculoskeletal Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: at correcting malocclusions or restoring the integrity of the dentition, interventions name: 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., outcomesModule primaryOutcomes measure: Frequency of relapses and repeated requests for correction of disorders bite or restoration of the integrity of the dentition., secondaryOutcomes measure: Change in pain intensity measured by visual analog scale (VAS)., secondaryOutcomes measure: Changes in functional parameters of the temporomandibular joint, including range of motion. joint, including range of motion., secondaryOutcomes measure: Improved quality of life, assessed using the OHRQoL (Oral Health Related Quality) scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Nmsi Dentmaster, city: Novosibirsk, state: Novosibirsk Region, zip: 630090, country: Russian Federation, contacts name: Tatiana A Gatilova, role: CONTACT, phone: 952939919, phoneExt: +7, email: gatilova@dentservice.ru, contacts name: Anastasia V Semivolova, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.0415, lon: 82.9346, hasResults: False