NCT07115797

Brief Summary

This study will be conducted to assess the effect of anterior repositioning splint and arthrocentesis with platelet-rich plasma injection compared to anterior repositioning splint only, in TMD patients with anterior disc displacement with reduction

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Sep 2025

Status
not yet recruiting

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 Progress63%
Sep 2025Oct 2026

First Submitted

Initial submission to the registry

August 4, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
21 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

August 4, 2025

Last Update Submit

August 4, 2025

Conditions

Keywords

ARS-PRP-Arthrocentsis

Outcome Measures

Primary Outcomes (1)

  • Maximum pain-free interincisal opening measured in mm by caliper

    from enrollment to the end of study at 6 months

Secondary Outcomes (1)

  • Pain measured by VAS scale

    from enrollment to the end of study at 6 months

Study Arms (2)

Comparator

ACTIVE COMPARATOR

ARS

Other: ARS

intervention

ACTIVE COMPARATOR

arthrocentesis then PRP injection and then ARS

Other: arthrocentesis - PRP injection -ARS

Interventions

oarthrocentesis then PRP injection and then ARS

intervention
ARSOTHER

Insertion Of ARS Only

Comparator

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suffering from internal derangement anterior disc displacement
  • Mouth Opening: Limited range of motion or difficulty with full mouth opening
  • Symptoms: Patients who report typical symptoms of TMJ dysfunction, such as pain, discomfort, or clicking sounds in the joint, especially when opening or closing the mouth.
  • Clicking: Audible clicking.
  • Pain: Pain or tenderness around the TMJ, often radiating to the ear, temple, or neck.

You may not qualify if:

  • Blood dyscrasias and Uncontrolled systemic diseases.
  • Rheumatoid Arthritis.
  • Infection in the pre-auricular area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
the observers will be blind to which group this case belongs. evaluators, and statisticians will be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's candidate

Study Record Dates

First Submitted

August 4, 2025

First Posted

August 11, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

August 11, 2025

Record last verified: 2025-08