Trial Outcomes & Findings for Treatment Outcomes for Temporomandibular Disorders (TMD) Via the Clayton Intra-aural Device (CID) Clinical Trial (NCT NCT00815776)
NCT ID: NCT00815776
Last Updated: 2010-08-24
Results Overview
The Craniomandibular Index (CMI) is designed to provide a basis for evaluating the severity of Temporomandibular Disorder (TMD) signs and symptoms. The assessment involves asking questions related to the condition of Mandibular Movement, TMJ noise, and palpations of the extraoral muscle, neck muscle, TMJ capsule and intraoral muscle. The answers to all of the questions are combined to calculate a score from 0 to 1 in which 0 represents no TMD signs and symptoms and 1 represents the most severe TMD signs and symptoms.
COMPLETED
PHASE1/PHASE2
152 participants
Change from Baseline in Craniomandibular Index (CMI) Scores at 3 months (in a scale)
2010-08-24
Participant Flow
Subjects completed a screening visit and were provided a diary record their Temporomandibular Disorder severity. Subjects returned to the clinic, were randomized if they qualified, and were assigned a treatment group. 150 subjects were planned, but the site over-enrolled 2 subjects due to a temporary problem with the database subject count.
Participant milestones
| Measure |
Clayton Intra-aural Device (CID) Group
Treatment group receiving the Clayton Intra-aural Device (CID)
|
Mouth Splint Group
Group receiving an intra-oral flat-plane splint
|
Jaw Exercise Group
Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
|
|---|---|---|---|
|
Overall Study
STARTED
|
60
|
64
|
28
|
|
Overall Study
COMPLETED
|
52
|
56
|
22
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment Outcomes for Temporomandibular Disorders (TMD) Via the Clayton Intra-aural Device (CID) Clinical Trial
Baseline characteristics by cohort
| Measure |
Clayton Intra-aural Device (CID) Group
n=60 Participants
Treatment group receiving the Clayton Intra-aural Device (CID)
|
Mouth Splint Group
n=64 Participants
Group receiving an intra-oral flat-plane splint
|
Jaw Exercise Group
n=28 Participants
Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
60 Participants
n=39 Participants
|
64 Participants
n=41 Participants
|
27 Participants
n=35 Participants
|
151 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
Age Continuous
|
37.29 years
STANDARD_DEVIATION 10.63 • n=39 Participants
|
38.02 years
STANDARD_DEVIATION 11.02 • n=41 Participants
|
36.27 years
STANDARD_DEVIATION 12.97 • n=35 Participants
|
37.41 years
STANDARD_DEVIATION 11.20 • n=31 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=39 Participants
|
53 Participants
n=41 Participants
|
25 Participants
n=35 Participants
|
126 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
26 Participants
n=31 Participants
|
|
Region of Enrollment
Mexico
|
60 participants
n=39 Participants
|
64 participants
n=41 Participants
|
28 participants
n=35 Participants
|
152 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline in Craniomandibular Index (CMI) Scores at 3 months (in a scale)Population: The arm that includes "0" (Jaw Exercise) is reported in Seconary Outcome Measure Table.
The Craniomandibular Index (CMI) is designed to provide a basis for evaluating the severity of Temporomandibular Disorder (TMD) signs and symptoms. The assessment involves asking questions related to the condition of Mandibular Movement, TMJ noise, and palpations of the extraoral muscle, neck muscle, TMJ capsule and intraoral muscle. The answers to all of the questions are combined to calculate a score from 0 to 1 in which 0 represents no TMD signs and symptoms and 1 represents the most severe TMD signs and symptoms.
Outcome measures
| Measure |
Clayton Intra-aural Device (CID) Group
n=60 Participants
Treatment group receiving the Clayton Intra-aural Device (CID)
|
Mouth Splint Group
n=64 Participants
Group receiving an intra-oral flat-plane splint
|
Jaw Exercise Group
Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
|
|---|---|---|---|
|
Change From Baseline In Craniomandibular Index (CMI) Scores At 3 Months (In A Scale)
|
.23 Units on a scale
Standard Deviation .21
|
.20 Units on a scale
Standard Deviation .15
|
—
|
PRIMARY outcome
Timeframe: From Baseline through 3 months post-baseline visit.Subjects were assessed for adverse events from the baseline visit through study completion (3 months post-baseline). Adverse events were categorized by the investigator for severity and relationship to treatment.
Outcome measures
| Measure |
Clayton Intra-aural Device (CID) Group
n=60 Participants
Treatment group receiving the Clayton Intra-aural Device (CID)
|
Mouth Splint Group
n=64 Participants
Group receiving an intra-oral flat-plane splint
|
Jaw Exercise Group
n=28 Participants
Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
|
|---|---|---|---|
|
Number of Subjects With Adverse Events
|
11 Participants
|
10 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Change from Baseline in Craniomandibular Index (CMI) Score at Three Months Post-Baseline (in a scale)Population: The arm that includes "0" (Mouth Splint Group) is included in the Primary Outcome Measure.
The Craniomandibular Index (CMI) is designed to provide a basis for evaluating the severity of Temporomandibular Disorder (TMD) signs and symptoms. The assessment involves asking questions related to the condition of Mandibular Movement, TMJ noise, and palpations of the extraoral muscle, neck muscle, TMJ capsule and intraoral muscle. The answers to all of the questions are combined to calculate a score from 0 to 1 in which 0 represents no TMD signs and symptoms and 1 represents the most severe TMD signs and symptoms.
Outcome measures
| Measure |
Clayton Intra-aural Device (CID) Group
n=60 Participants
Treatment group receiving the Clayton Intra-aural Device (CID)
|
Mouth Splint Group
Group receiving an intra-oral flat-plane splint
|
Jaw Exercise Group
n=28 Participants
Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
|
|---|---|---|---|
|
Change From Baseline In Craniomandibular Index (CMI) Scores At 3 Months (In A Scale)
|
.23 Units on a scale
Standard Deviation .21
|
—
|
.15 Units on a scale
Standard Deviation .13
|
Adverse Events
Clayton Intra-aural Device (CID) Group
Mouth Splint Group
Jaw Exercise Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Clayton Intra-aural Device (CID) Group
n=60 participants at risk
Treatment group receiving the Clayton Intra-aural Device (CID)
|
Mouth Splint Group
n=64 participants at risk
Group receiving an intra-oral flat-plane splint
|
Jaw Exercise Group
n=28 participants at risk
Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
|
|---|---|---|---|
|
General disorders
Discomfort or Pain
|
6.7%
4/60 • Number of events 5 • Continuous, from baseline through study exit.
After consent, the baseline visit was the point at which adverse event reporting began. Adverse events were collected continuously throughout the study until individual subject study exit.
|
9.4%
6/64 • Number of events 7 • Continuous, from baseline through study exit.
After consent, the baseline visit was the point at which adverse event reporting began. Adverse events were collected continuously throughout the study until individual subject study exit.
|
7.1%
2/28 • Number of events 2 • Continuous, from baseline through study exit.
After consent, the baseline visit was the point at which adverse event reporting began. Adverse events were collected continuously throughout the study until individual subject study exit.
|
|
General disorders
Headache
|
5.0%
3/60 • Number of events 3 • Continuous, from baseline through study exit.
After consent, the baseline visit was the point at which adverse event reporting began. Adverse events were collected continuously throughout the study until individual subject study exit.
|
4.7%
3/64 • Number of events 6 • Continuous, from baseline through study exit.
After consent, the baseline visit was the point at which adverse event reporting began. Adverse events were collected continuously throughout the study until individual subject study exit.
|
3.6%
1/28 • Number of events 1 • Continuous, from baseline through study exit.
After consent, the baseline visit was the point at which adverse event reporting began. Adverse events were collected continuously throughout the study until individual subject study exit.
|
Additional Information
Lawrence G. Clayton, M.A., Study Director
Ascentia Health, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place