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Treatment Outcomes for Temporomandibular Disorders (TMD) Via the Clayton Intra-aural Device (CID) Clinical Trial

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ClinicalTrials.gov Identifier: NCT00815776
Recruitment Status : Completed
First Posted : December 30, 2008
Results First Posted : August 6, 2010
Last Update Posted : August 24, 2010
Sponsor:
Information provided by:
Ascentia Health, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Temporomandibular Disorders
Interventions Device: Clayton Intra-aural Device (CID)
Device: Mouth Splint
Other: Exercise Group
Enrollment 152
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Clayton Intra-aural Device (CID) Group Mouth Splint Group Jaw Exercise Group
Hide Arm/Group Description Treatment group receiving the Clayton Intra-aural Device (CID) Group receiving an intra-oral flat-plane splint Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
Period Title: Overall Study
Started 60 64 28
Completed 52 56 22
Not Completed 8 8 6
Arm/Group Title Clayton Intra-aural Device (CID) Group Mouth Splint Group Jaw Exercise Group Total
Hide Arm/Group Description Treatment group receiving the Clayton Intra-aural Device (CID) Group receiving an intra-oral flat-plane splint Jaw exercise group, who receive no device but completed a study-specified jaw exercise program Total of all reporting groups
Overall Number of Baseline Participants 60 64 28 152
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 64 participants 28 participants 152 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
60
 100.0%
64
 100.0%
27
  96.4%
151
  99.3%
>=65 years
0
   0.0%
0
   0.0%
1
   3.6%
1
   0.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 64 participants 28 participants 152 participants
37.29  (10.63) 38.02  (11.02) 36.27  (12.97) 37.41  (11.20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 64 participants 28 participants 152 participants
Female
48
  80.0%
53
  82.8%
25
  89.3%
126
  82.9%
Male
12
  20.0%
11
  17.2%
3
  10.7%
26
  17.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Mexico Number Analyzed 60 participants 64 participants 28 participants 152 participants
60 64 28 152
1.Primary Outcome
Title Change From Baseline In Craniomandibular Index (CMI) Scores At 3 Months (In A Scale)
Hide Description 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.
Time Frame Change from Baseline in Craniomandibular Index (CMI) Scores at 3 months (in a scale)
Hide Outcome Measure Data
Hide Analysis Population Description
The arm that includes "0" (Jaw Exercise) is reported in Seconary Outcome Measure Table.
Arm/Group Title Clayton Intra-aural Device (CID) Group Mouth Splint Group Jaw Exercise Group
Hide Arm/Group Description:
Treatment group receiving the Clayton Intra-aural Device (CID)
Group receiving an intra-oral flat-plane splint
Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
Overall Number of Participants Analyzed 60 64 0
Mean (Standard Deviation)
Unit of Measure: Units on a scale
.23  (.21) .20  (.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clayton Intra-aural Device (CID) Group, Mouth Splint Group
Comments The LS means were used to calculate the test statistic for non-inferiority of the CID to the traditional splint device. The null hypothesis was that the reduction of CMI score for the CID is less than 80% of the reduction in the splint group. A significant p-value(< 0.05) would reject this null hypothesis in favor of the alternative hypothesis that the CID demonstrated a reduction of at least 80% of that seen in the splint group.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The unadjusted reductions are straight arithmetic averages and are supplied for informational purposes only. The pooled variance is calculated from the unadjusted standard deviations, and the t statistic is calculated as described in Laster (2003) using an average sample size of 54 and 106 degrees of freedom.
Statistical Test of Hypothesis P-Value <0.0096
Comments [Not Specified]
Method student's t-test with 2n-2 DoF
Comments [Not Specified]
2.Primary Outcome
Title Number of Subjects With Adverse Events
Hide Description 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.
Time Frame From Baseline through 3 months post-baseline visit.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clayton Intra-aural Device (CID) Group Mouth Splint Group Jaw Exercise Group
Hide Arm/Group Description:
Treatment group receiving the Clayton Intra-aural Device (CID)
Group receiving an intra-oral flat-plane splint
Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
Overall Number of Participants Analyzed 60 64 28
Measure Type: Number
Unit of Measure: Participants
11 10 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clayton Intra-aural Device (CID) Group, Mouth Splint Group
Comments Safety analyses were performed on the ITT population. The safety of the CID was characterized by the proportion of subjects with all serious and non-serious study-related adverse events and Unanticipated Adverse Device Events (UADEs). In addition, summaries of the onset, duration, severity, treatment relatedness, and outcome of all adverse events were reported.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Safety analyses were performed on the ITT population.
Statistical Test of Hypothesis P-Value 0.688
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline In Craniomandibular Index (CMI) Scores At 3 Months (In A Scale)
Hide Description 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.
Time Frame Change from Baseline in Craniomandibular Index (CMI) Score at Three Months Post-Baseline (in a scale)
Hide Outcome Measure Data
Hide Analysis Population Description
The arm that includes "0" (Mouth Splint Group) is included in the Primary Outcome Measure.
Arm/Group Title Clayton Intra-aural Device (CID) Group Mouth Splint Group Jaw Exercise Group
Hide Arm/Group Description:
This group of subjects received the Clayton Intra-aural Device
This group was not part of the analysis
This subject group received no device but was assigned to complete a study-specified jaw exercise program
Overall Number of Participants Analyzed 60 0 28
Mean (Standard Deviation)
Unit of Measure: Units on a scale
.23  (.21) .15  (.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clayton Intra-aural Device (CID) Group, Jaw Exercise Group
Comments A significant p-value for the treatment group effect would indicate that the CID group and Exercise group were significantly different, based on results of a two-sided t test for difference in means, with alpha=0.5, and allowing for unequal sample sizes.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .2995
Comments From the pilot study, 50 subjects (CID arm) and 25 (exercise arm) were required for at least 80% power to detect a difference in the mean reduction in CMI scores between arms if muPassive is less than approximately 70% of that in the CID arm.
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Continuous, from baseline through study exit.
Adverse Event Reporting Description 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.
 
Arm/Group Title Clayton Intra-aural Device (CID) Group Mouth Splint Group Jaw Exercise Group
Hide Arm/Group Description Treatment group receiving the Clayton Intra-aural Device (CID) Group receiving an intra-oral flat-plane splint Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
All-Cause Mortality
Clayton Intra-aural Device (CID) Group Mouth Splint Group Jaw Exercise Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Clayton Intra-aural Device (CID) Group Mouth Splint Group Jaw Exercise Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/60 (0.00%)      0/64 (0.00%)      0/28 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Clayton Intra-aural Device (CID) Group Mouth Splint Group Jaw Exercise Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/60 (11.67%)      9/64 (14.06%)      3/28 (10.71%)    
General disorders       
Discomfort or Pain * 1  4/60 (6.67%)  5 6/64 (9.38%)  7 2/28 (7.14%)  2
Headache * 1  3/60 (5.00%)  3 3/64 (4.69%)  6 1/28 (3.57%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, other
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lawrence G. Clayton, M.A., Study Director
Organization: Ascentia Health, Inc.
Phone: (815) 484-9258
EMail: LGClayton@aol.com
Layout table for additonal information
Responsible Party: Lawrence G. Clayton, Ascentia Health, Inc.
ClinicalTrials.gov Identifier: NCT00815776     History of Changes
Other Study ID Numbers: CID2007
First Submitted: December 29, 2008
First Posted: December 30, 2008
Results First Submitted: March 23, 2010
Results First Posted: August 6, 2010
Last Update Posted: August 24, 2010