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

February 22, 2024 updated by: NMSI DENTMASTER

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.

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Russian Federation
    • Novosibirsk Region
      • Novosibirsk, Novosibirsk Region, Russian Federation, 630090
        • Nmsi Dentmaster
        • Contact:
        • Principal Investigator:
          • Anastasia V Semivolova

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: receive standard treatment group
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.
Experimental: comprehensive treatment group
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.
): 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of relapses and repeated requests for correction of disorders bite or restoration of the integrity of the dentition.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain intensity measured by visual analog scale (VAS).
Time Frame: 12 months

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
Changes in functional parameters of the temporomandibular joint, including range of motion. joint, including range of motion.
Time Frame: 12 month

0- No changes

  1. The changes are positive
  2. Changes are negative
12 month
Improved quality of life, assessed using the OHRQoL (Oral Health Related Quality) scale
Time Frame: 12 month

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NMSI DENTMASTER

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 10, 2024

Primary Completion (Estimated)

June 15, 2025

Study Completion (Estimated)

October 15, 2025

Study Registration Dates

First Submitted

February 8, 2024

First Submitted That Met QC Criteria

February 8, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DM001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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