Vacuum Therapy and Stabilization Splints Efficacious for the Management of Temporo-mandibular Joint Osteoarthritis

NCT06228612 | Completed

• 1 other identifier: A12060922
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to determine and compare the clinical efficacy of VT and STT alone or in combination for the patients with temporo-mandibular joint (TMJ) osteoarthritis.

Conditions

Osteoarthritis

Keywords

TMJ, osteoarthritis, vacuum, stabilization splint.

Outcome Measures

Primary Outcomes (1)

• Maximum comfortable mouth opening (MCO),

  Maximum comfortable mouth opening (MCO) was measured using millimeter ruler between the incisal edges plus the overbite while the patient opens at maximum comfortable opening.

  6 months

Secondary Outcomes (1)

• visual analogue scale (VAS),

  6 months

Other Outcomes (2)

• Verbal Rating Scale (VRS)

  6 months

• Patient Global Impression of Change Scale (PGICS),

  6 months

Study Arms (3)

group I:vacuum therapy

ACTIVE COMPARATOR

group I:vacuum therapy VT:patients who were diagnosed with TMJ osteoarthritis. The patients received Isolated vacuum therapy VT

Device: vacuum therapy

group II: maxillary stabilization splint (MSS)

ACTIVE COMPARATOR

group II, patients who were diagnosed with TMJ osteoarthritis. The patients received stabilization splint therapy (STT)

Device: maxillary stabilization splint (MSS)

group III: vacuum therapy VT and maxillary stabilization splint (MSS)

ACTIVE COMPARATOR

group III: patients who were diagnosed with TMJ osteoarthritis. The patients received combined VT and SST.

Device: vacuum therapy VT and maxillary stabilization splint (MSS)

Interventions

vacuum therapy DEVICE

vacuum therapy :all patients were informed about initial suction sensation and possible appearance of bruising at the application site. Basic vacuum therapy equipment (cangexia, China) was utilized including a manual suction pump, plastic cups of 40 mm diameter with rolled edge, and anti-septic tools.

group I:vacuum therapy

maxillary stabilization splint (MSS) DEVICE

maxillary stabilization splint (MSS): was constructed for each patient from hard, heat-cured clear acrylic resin and fitted to the maxillary teeth. On the mounted master casts, the vertical dimension was adjusted to provide 3 mm of vertical space between the closest opposing cusps of the maxillary and mandibular teeth.

group II: maxillary stabilization splint (MSS)

vacuum therapy VT and maxillary stabilization splint (MSS) DEVICE

vacuum therapy VT and maxillary stabilization splint (MSS): both Basic vacuum therapy and maxillary stabilization splint :Procedures were the same as in group I and II.

group III: vacuum therapy VT and maxillary stabilization splint (MSS)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Fatma A. EL Waseef

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Fatma Ahmad EL-Waseef, Associate professor

  Faculty of Dentistry.Mansoura University,Prosthodontics Departement

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patient's randomization was performed by two assistants who did not participate in the trial. One assistant had prepared sequentially numbered sealed envelopes with random assignment. The assignment of the treatment was then completed by another assistant from outside the trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patient's randomization was performed by two assistants who did not participate in the trial. One assistant had prepared sequentially numbered sealed envelopes with random assignment. The assignment of the treatment was then completed by another assistant from outside the trial. Patients whose treatment plans included vacuum therapy (VT) were designated group (I) and included 14 patients, and those with stabilization splint therapy (SST) were designated (group (II) and included 14 patients. Patients whose treatment plans included both vacuum therapy and splint therapy (VT + SST) were designated as group (III) and included 14 patients.

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: January 29, 2024
• Study Start: January 20, 2021
• Primary Completion: December 3, 2022
• Study Completion: November 17, 2023
• Last Updated: January 29, 2024

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)