Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-28 @ 5:04 PM
Study NCT ID:
NCT01409850
Status:
TERMINATED
Last Update Posted:
2014-12-03
First Post:
2011-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Study of Two Splints Used for Treatment of Acute Temporomandibular Pain.
Sponsor:
Heidelberg University
Organization:
Study Overview
Official Title:
Pilot Clinical Trial on the Treatment Effectiveness of Two Splints for Acute Temporomandibular Pain.
Status:
TERMINATED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Very slow enrollment of participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The most commonly applied treatment against acute temporomandibular signs and symptoms is pharmacotherapy. The evidence on treatment efficacy of non-medication treatments (like splints) is very low. Two very commonly used splints are the Aqualizer® and the soft polyester splint. These are splints applied for a short period of time, until the treatment with a hard splint and/or physiotherapy begins. Aim of this study is to compare the clinical short-time efficacy of these two splints for the treatment of acute temporomandibular pain and compare it to a control group receiving no therapy for that short time.
The study hypothesis is that there is a difference in pain reduction between the three groups of patients (two intervention and one control group).
The study hypothesis is that there is a difference in pain reduction between the three groups of patients (two intervention and one control group).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: