NCT06781138

Brief Summary

This study is a randomized clinical trial comparing the effectiveness of conventional stabilization splints versus 3D-designed and printed stabilization splints in treating temporomandibular disorders (TMDs). TMD is a common cause of orofacial pain affecting the jaw joint and surrounding muscles. The trial evaluates outcomes such as pain reduction, clinical improvement, patient satisfaction, and time efficiency. By exploring a fully digital workflow for splint fabrication, this study aims to provide evidence on whether the newer 3D-printed approach offers superior results to conventional methods in terms of clinical effectiveness and procedural efficiency.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 14, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 17, 2025

Completed
Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

January 14, 2025

Last Update Submit

January 14, 2025

Conditions

Temporomandibular Disorders (TMD)

Keywords

TMD Joint

Outcome Measures

Primary Outcomes (1)

  • clinical improvement

    Visual analogue scale

    after 8 weeks

Study Arms (2)

Conventional stabilization splint

ACTIVE COMPARATOR
Device: Conventional stabilization splint

3D designed and printed stabilization splint

EXPERIMENTAL
Device: 3D designed and printed stabilization splints

Interventions

Conventional stabilization splintDEVICE

conventional versus 3D designed and printed stabilization splints

Conventional stabilization splint
3D designed and printed stabilization splintsDEVICE

Conventional versus 3D designed and printed stabilization splints

3D designed and printed stabilization splint

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult patients aged (18-40) presenting with myalgia.

You may not qualify if:

  • Previous orthodontic treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Officials

  • Abdallah Ahmed Hassan Hamed Refai, MSc candidate

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

January 14, 2025

First Posted

January 17, 2025

Study Start

June 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

January 17, 2025

Record last verified: 2025-01

Locations

EG(1)