NCT06619574

Brief Summary

This study is being performed to determine if the use of the Dental Compass Articular and its software will produce therapeutic splints for TMD accurately and successfully, compare favorably with a cohort treated without the Dental Compass (for number of visits, splint modifications, and required CBCTs).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress65%
Nov 2024Mar 2027

First Submitted

Initial submission to the registry

September 27, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

November 8, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

February 6, 2025

Status Verified

February 1, 2025

Enrollment Period

2 years

First QC Date

September 27, 2024

Last Update Submit

February 4, 2025

Conditions

Temporomandibular Joint Syndrome

Outcome Measures

Primary Outcomes (3)

  • Number of clinic visits

    Number of clinic visits from initial evaluation to confirmation of final therapeutic splint provision

    3-6 months

  • Number of cone beam CTs (CBCTs)

    Number of CBCTs obtained from initial evaluation to confirmation of final therapeutic splint provision

    3-6 months

  • Number of splint modifications

    Number of splint modifications obtained from initial evaluation to confirmation of final therapeutic splint provision

    3-6 months

Secondary Outcomes (5)

  • Gelb 4/7 position achieved during treatment (3D group only)

    3-6 months

  • Anterior joint space of 1.8 mm or more achieved during treatment (3D group only)

    3-6 months

  • Posterior joint space of 1.8 mm or more achieved during treatment (3D group only)

    3-6 months

  • Improvement in total airway volume

    3-6 months

  • Improvement in minimum airway diameter

    3-6 months

Study Arms (2)

3D Analysis Group

EXPERIMENTAL

Compass Use

Device: 3D Analysis Group

Manual Analysis Cohort

ACTIVE COMPARATOR

Manual Use only

Other: Manual Analysis Cohort

Interventions

3D Analysis GroupDEVICE

Dental Compass and Dental Compass software used for therapeutic splint fabrication

3D Analysis Group
Manual Analysis CohortOTHER

Manual methods used for therapeutic splint fabrication

Manual Analysis Cohort

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • TMJ dysfunction and pain
  • CBCT indicates a non-Gelb 4/7 position or \< 1.8 mm bone to bone interval between the mandibular condyle and mandibular fossa anteriorly or posteriorly.

You may not qualify if:

  • Planning a move within 9 months.
  • Unwilling to provide two phone numbers and two email contacts.
  • Not willing to express a willingness to come in for 4-6 month follow up if they have marked improvement or improvement in symptoms.
  • Not living within 90-minute drive from clinic
  • Transportation not reliable
  • Involved in any other TMD study
  • Life threatening illness or major surgery planned
  • Other major life stress that might interfere with completing the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skalff Dental Studio and Technologies 103 C West Broadway Street #3736

Gainesville, Texas, 76240, United States

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Dysfunction Syndrome

Condition Hierarchy (Ancestors)

Temporomandibular Joint DisordersCraniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesMyofascial Pain SyndromesStomatognathic Diseases

Study Officials

  • Kenneth D Reeves, MD

    K. Dean Reeves, M.D., P.A.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth D Reeves, MD

CONTACT

9139637750deanreevesMD@gmail.com

Lourens A duPreez, MDT, HDDT

CONTACT

940-580-9486lourensdupreez903@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Cohort comparison study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 27, 2024

First Posted

October 1, 2024

Study Start

November 8, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

February 6, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

All non identifying data

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Indefinitely
Access Criteria
By email request to P.I. at DeanReevesMD@gmail.com

Locations

US(1)