NCT05959174

Brief Summary

  • 20 patients will be divided into 2 groups
  • Group 1 : in which conventional appliance will be constructed after alginate impression
  • Group 2 : in which 3d printed appliance will be constructed after intra-oral scanning

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 17, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 25, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

11 months

First QC Date

July 17, 2023

Last Update Submit

April 15, 2024

Conditions

Myofacial Pain Syndromes

Outcome Measures

Primary Outcomes (1)

  • visual analogue scale

    pain assessment by visual analog scale (0-10) as 0 means no pain and 10 means severe pain immediately postoperative and 6 months later

    Change from immediate postoperative to 6 months

Study Arms (2)

3d printed appliance

ACTIVE COMPARATOR
Device: 3D printed mitchigen appliance

side chair appliance

ACTIVE COMPARATOR
Device: side chair appliance

Interventions

3D printed mitchigen applianceDEVICE

the process of appliance construction done by intra-oral scanning of the arch and 3d printing

3d printed appliance
side chair applianceDEVICE

the impresion will be taken to make a cast to reconstruct the appliance

side chair appliance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with bruxism
  • Trigger points
  • Medically stable

You may not qualify if:

  • absence of other TMJ problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaimaa Refahee

Cairo, Egypt

Location

MeSH Terms

Conditions

Facial Neuralgia

Condition Hierarchy (Ancestors)

Facial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve DiseasesNervous System Diseases

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
lecturer of oral and maxillofacial surgery

Study Record Dates

First Submitted

July 17, 2023

First Posted

July 25, 2023

Study Start

June 15, 2023

Primary Completion

April 28, 2024

Study Completion

May 30, 2024

Last Updated

April 17, 2024

Record last verified: 2024-04

Locations

EG(1)