MalocclusionNCT06263504
The Influence of Complex Correction of Dental and Musculoskeletal Systems on the Frequency of Relapses of Functional Disorders in Patients With Dental Pathologies.
A study testing at correcting malocclusions or restoring the integrity of the dentition and 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. in people with Malocclusion and Musculoskeletal Disorder, run by NMSI DENTMASTER at 1 site in Russia.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Malocclusion, Musculoskeletal Disorder
- What is being tested?
- at correcting malocclusions or restoring the integrity of the dentition and 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 of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- 10 Mar 2024to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Nmsi Dentmaster
Novosibirsk, Novosibirsk Oblast, 630090
Tatiana A Gatilova, 952939919 ext. +7, gatilova@dentservice.ru
Anastasia V Semivolova
About this study
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
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.
Read more
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.
- Conditions
- Malocclusion, Musculoskeletal Disorder
- Being tested
- at correcting malocclusions or restoring the integrity of the dentition, 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.
- Keywords
- Malocclusion, Musculoskeletal Disorders, orthodontics, dental prosthetics, complex correction of the dental system
- Medical subject headings
- Malocclusion, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
at correcting malocclusions or restoring the integrity of the dentitionProcedure or surgery
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.Procedure or surgery
): 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.
| Study group | Role | What they receive |
|---|---|---|
| receive standard treatment group | Active comparator | Not described Receives: Procedure: at correcting malocclusions or restoring the integrity of the dentition |
| comprehensive treatment group | Experimental | Not described Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of relapses and repeated requests for correction of disorders bite or restoration of the integrity of the dentition.
Measured: 12 months
Secondary outcomes (3)
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).
Measured: 12 months
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
Measured: 12 month
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
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start10 Mar 2024 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NMSI DENTMASTER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263504
- Sponsor's protocol ID
- DM001
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06263504
- Acronym / sponsor ID
- DM001
- Conditions
- Malocclusion, Musculoskeletal Disorder
- Keywords
- Malocclusion, Musculoskeletal Disorders, orthodontics, dental prosthetics, complex correction of the dental system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- NMSI DENTMASTERUniversity, hospital or other
- Study start
- 10 Mar 2024 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| receive standard treatment group | Active comparator | Procedure: at correcting malocclusions or restoring the integrity of the dentition |
| comprehensive treatment group | Experimental | 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Diagnosed malocclusion or dentition insufficiency, confirmed by a dentist.
Key exclusion criteria (13 listed)
- Systemic diseases affecting bone metabolism (eg osteoporosis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| at correcting malocclusions or restoring the integrity of the dentitionPatients 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. | Procedure or surgery | receive standard treatment group |
| 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. | Procedure or surgery | comprehensive treatment group |
Primary outcome
Frequency of relapses and repeated requests for correction of disorders bite or restoration of the integrity of the dentition.
Time frame: 12 months
3 secondary outcomes
Change in pain intensity measured by visual analog scale (VAS).
Time frame: 12 months
Changes in functional parameters of the temporomandibular joint, including range of motion. joint, including range of motion.
Time frame: 12 month
Improved quality of life, assessed using the OHRQoL (Oral Health Related Quality) scale
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing at correcting malocclusions or restoring the integrity of the dentition and 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. in people with Malocclusion and Musculoskeletal Disorder, run by NMSI DENTMASTER at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olga A Belasik (9137173754 ext. +7, olga_belasik@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of relapses and repeated requests for correction of disorders bite or restoration of the integrity of the dentition. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.