Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-25 @ 5:32 PM
Study NCT ID:
NCT06263504
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-26
First Post:
2024-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Influence of Complex Correction of Dental and Musculoskeletal Systems on the Frequency of Relapses of Functional Disorders in Patients With Dental Pathologies.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008310', 'term': 'Malocclusion'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-22', 'studyFirstSubmitDate': '2024-02-08', 'studyFirstSubmitQcDate': '2024-02-08', 'lastUpdatePostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of relapses and repeated requests for correction of disorders bite or restoration of the integrity of the dentition.', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Change in pain intensity measured by visual analog scale (VAS).', 'timeFrame': '12 months', 'description': 'A Visual Analogue Scale - VAS Purpose: pain intensity assessments\n\nInterpretation:\n\n0 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).'}, {'measure': 'Changes in functional parameters of the temporomandibular joint, including range of motion. joint, including range of motion.', 'timeFrame': '12 month', 'description': '0- No changes\n\n1. The changes are positive\n2. Changes are negative'}, {'measure': 'Improved quality of life, assessed using the OHRQoL (Oral Health Related Quality) scale', 'timeFrame': '12 month', 'description': '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).\n\nThe 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'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Malocclusion', 'Musculoskeletal Disorders', 'orthodontics', 'dental prosthetics', 'complex correction of the dental system'], 'conditions': ['Malocclusion', 'Musculoskeletal Disorder']}, '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.\n\nGroup 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.\n\nThe endpoints will be :\n\nPrimary endpoint:\n\n• Frequency of relapses and repeated requests for correction of disorders bite or restoration of the integrity of the dentition within 12 months after treatment.\n\nSecondary endpoints:\n\n* Change in pain intensity measured by visual analog scale (VAS).\n* Improvement of functional indicators of the temporomandibular joint, including range of motion.\n* Improved quality of life, assessed using the OHRQoL (Oral Health Related Quality) scale All endpoints will be evaluated within 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed malocclusion or dentition insufficiency, confirmed by a dentist.\n\n * Presence of diseases of the musculoskeletal system, confirmed orthopedist or rheumatologist.\n * Acquired limb deformities (for example, flat feet, valgus or varus deformity).\n * Deforming dorsopathies (kyphosis, lordosis, scoliosis, osteochondrosis).\n * Consent to participate in the study and follow the treatment protocol.\n * Sufficient general physical and mental fitness to participate in the study\n\nExclusion Criteria:\n\n* Systemic diseases affecting bone metabolism (eg osteoporosis).\n\n * Progressive neurological diseases.\n * Current treatment with steroids or immunosuppressive drugs.\n * Presence of malignant neoplasms.\n * Psychiatric disorders that prevent compliance protocol.\n * Pregnancy or lactation period.\n * Carrying out dental or orthopedic treatment in recent 6 months.\n * Skeletal malocclusions.\n * Diseases of the temporomandibular joint.\n * Congenital pathologies of the musculoskeletal system.\n * Arthropathy.\n * Systemic connective tissue diseases.\n * Biomechanical lesions of the musculoskeletal system.'}, 'identificationModule': {'nctId': 'NCT06263504', 'briefTitle': 'The Influence of Complex Correction of Dental and Musculoskeletal Systems on the Frequency of Relapses of Functional Disorders in Patients With Dental Pathologies.', 'organization': {'class': 'OTHER', 'fullName': 'NMSI DENTMASTER'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'DM001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'receive standard treatment group', 'interventionNames': ['Procedure: at correcting malocclusions or restoring the integrity of the dentition']}, {'type': 'EXPERIMENTAL', 'label': 'comprehensive treatment group', 'interventionNames': ['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': [{'name': 'at correcting malocclusions or restoring the integrity of the dentition', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['receive standard treatment group']}, {'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.', 'type': 'PROCEDURE', 'description': '): 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.', 'armGroupLabels': ['comprehensive treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '630090', 'city': 'Novosibirsk', 'state': 'Novosibirsk Oblast', 'country': 'Russia', 'contacts': [{'name': 'Tatiana A Gatilova', 'role': 'CONTACT', 'email': 'gatilova@dentservice.ru', 'phone': '952939919', 'phoneExt': '+7'}, {'name': 'Anastasia V Semivolova', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nmsi Dentmaster', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}], 'centralContacts': [{'name': 'Olga A Belasik', 'role': 'CONTACT', 'email': 'olga_belasik@mail.ru', 'phone': '9137173754', 'phoneExt': '+7'}, {'name': 'Tatiana A Gatilova', 'role': 'CONTACT', 'email': 'gatilova@dentservice.ru', 'phone': '9529399919', 'phoneExt': '+7'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NMSI DENTMASTER', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}