Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06263504
Other study ID # DM001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT02914431 - Personalized Titanium Plates vs CAD/CAM Surgical Splints in Maxillary Repositioning of Orthognathic Surgery N/A
Recruiting NCT05383820 - Effect of Paracetamol and Ketorolac on RANK-L Levels in Patients Starting Orthodontic Treatment Phase 4
Not yet recruiting NCT03794726 - Comparison of Orthodontic Molar Protraction With and Without Adjunctive Surgery N/A
Not yet recruiting NCT03513003 - The Use of a Pacifier to Correct Malocclusions in Young Children N/A
Completed NCT02603289 - One Week Aligner Evaluation
Terminated NCT01210547 - Three-dimensional Assessment of Craniofacial Structures N/A
Completed NCT01463839 - Sleep Disorder and Oral Habits in Children N/A
Recruiting NCT04946201 - Premolar Extractions for Obstructive Sleep Apnea in Children With Overjet
Recruiting NCT04117360 - Orthognathic Speech Pathology: Phonetic Contrasts of Patients With Dental Discrepancies Pre- and Post-Treatment Analyses
Active, not recruiting NCT06291129 - Gingival Health and Malocclusion Among Type 1 Diabetic Children and Adolescents N/A
Recruiting NCT05684510 - Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy N/A
Completed NCT02659813 - Orthodontic Archwire Effectiveness Trial N/A
Completed NCT02427763 - Microbiological and Epithelial Evaluation Related to the Use of Orthodontic Thermoplastic Device Phase 0
Completed NCT02267811 - The Effect of OrthoPulse™ on the Rate of Orthodontic Tooth Movement N/A
Completed NCT01962012 - Effect of AcceleDent® Aura on Orthodontic Tooth Movement With Aligners Phase 4
Completed NCT03405961 - A Comparison of Conventional Versus Digital PAR (Peer Assessment Rating) Scores Using an Intraoral Scanner
Completed NCT05356780 - Predictability of Orthodontic Tooth Movement With Invisalign Aligners
Recruiting NCT06218641 - Discomfort Perceived by a Cohort of Patients Treated With Aligners and Attachments Placed According to Two Different Protocols N/A
Completed NCT05711160 - Comparison of the Accuracy and Reliability of Measurements Made on CBCT and IOS Images With Their made-on Plaster Models.
Recruiting NCT06140043 - Augmented Reality for Orthognatic Surgery Patient Education Phase 2/Phase 3