Trial Outcomes & Findings for Occlusal Adjustment as Treatment for Chronic Orofacial Pain (NCT NCT00899717)
NCT ID: NCT00899717
Last Updated: 2013-07-26
Results Overview
The primary outcome was self-reported pain intensity on a 0 to 10 cm visual analog scale considering the temporomandibular disorder side, being 0="No pain" and 10="Worst imaginable pain"
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Baseline, immediately after therapy, 3 months and 6 months after therapy
Results posted on
2013-07-26
Participant Flow
Participant milestones
| Measure |
Real Occlusal Adjustment
Occlusal adjustment : modification of occlusal surfaces
|
Sham Occlusal Adjustment
Placebo occlusal adjustment : Simulated modification of occlusal surfaces
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Occlusal Adjustment as Treatment for Chronic Orofacial Pain
Baseline characteristics by cohort
| Measure |
Real Occlusal Adjustment
n=10 Participants
|
Sham Occlusal Adjustment
n=11 Participants
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
34.7 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
29.73 years
STANDARD_DEVIATION 8.61 • n=7 Participants
|
32.1 years
STANDARD_DEVIATION 11.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, immediately after therapy, 3 months and 6 months after therapyThe primary outcome was self-reported pain intensity on a 0 to 10 cm visual analog scale considering the temporomandibular disorder side, being 0="No pain" and 10="Worst imaginable pain"
Outcome measures
| Measure |
Real Occlusal Adjustment
n=10 Participants
|
Placebo Occlusal Adjustment
n=11 Participants
|
|---|---|---|
|
Visual Analogic Scale for Pain Intensity (0-10)
Baseline
|
6.52 units on a scale
Standard Deviation 1.84 • Interval 5.75 to 7.56
|
4.8 units on a scale
Standard Deviation 1.99 • Interval 2.75 to 7.0
|
|
Visual Analogic Scale for Pain Intensity (0-10)
Immediately after therapy
|
.81 units on a scale
Standard Deviation 1.56
|
2.05 units on a scale
Standard Deviation 2.07
|
|
Visual Analogic Scale for Pain Intensity (0-10)
3 months after therapy
|
2.25 units on a scale
Standard Deviation 2.68
|
3.80 units on a scale
Standard Deviation 2.94
|
|
Visual Analogic Scale for Pain Intensity (0-10)
6 months after therapy
|
.40 units on a scale
Standard Deviation .97
|
4 units on a scale
Standard Deviation 2.31
|
SECONDARY outcome
Timeframe: Before and 6 months after therapyPopulation: Only tests from 15 participants were suitable because of slow or too many positive responses.
Scale name: Global Severity Index. Scale graded from 0 to 4. Scores increases as the symptoms severity increases.
Outcome measures
| Measure |
Real Occlusal Adjustment
n=8 Participants
|
Placebo Occlusal Adjustment
n=7 Participants
|
|---|---|---|
|
Symptom Checklist-90-Revised (SCL-90-R®)
6 months after therapy Global Severity Index
|
0.75 units on a scale
Standard Deviation 0.5
|
0.51 units on a scale
Standard Deviation 0.58
|
|
Symptom Checklist-90-Revised (SCL-90-R®)
Baseline Global Severity Index
|
1.32 units on a scale
Standard Deviation 0.91
|
0.58 units on a scale
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: Before and 6 months after therapyThe change in the habitual chewing side of each participant across the study
Outcome measures
| Measure |
Real Occlusal Adjustment
n=10 Participants
|
Placebo Occlusal Adjustment
n=11 Participants
|
|---|---|---|
|
Preferred Chewing Side
Baseline
|
0 participants
|
0 participants
|
|
Preferred Chewing Side
6 months after therapy
|
8 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 6 months (before and after therapy) including 4 assessment points: pre-treatment, post-treatment, 3- and 6-month follow upMaximum voluntary unassisted mouth opening
Outcome measures
| Measure |
Real Occlusal Adjustment
n=10 Participants
|
Placebo Occlusal Adjustment
n=11 Participants
|
|---|---|---|
|
Maximum Mouth Opening (mm)
Baseline
|
41.6 mm
Standard Deviation 8.26
|
42.36 mm
Standard Deviation 10.55
|
|
Maximum Mouth Opening (mm)
Immediately after therapy
|
45.50 mm
Standard Deviation 7.89
|
45.07 mm
Standard Deviation 10.61
|
|
Maximum Mouth Opening (mm)
3 months after therapy
|
47.10 mm
Standard Deviation 5.26
|
41.27 mm
Standard Deviation 11.31
|
|
Maximum Mouth Opening (mm)
6 months after therapy
|
49.20 mm
Standard Deviation 7.28
|
41.73 mm
Standard Deviation 10.34
|
SECONDARY outcome
Timeframe: BaselineParasagittal plane condylar path angles tracings in relation to the Frankfort line were made following the Gysi extraoral method.
Outcome measures
| Measure |
Real Occlusal Adjustment
n=10 Participants
|
Placebo Occlusal Adjustment
n=11 Participants
|
|---|---|---|
|
Condylar Path Angles
Right condylar path angle
|
52.33 degrees
Standard Deviation 10.28
|
49 degrees
Standard Deviation 8.09
|
|
Condylar Path Angles
Left condylar path angle
|
49.20 degrees
Standard Deviation 11.68
|
48.27 degrees
Standard Deviation 10.21
|
|
Condylar Path Angles
Pain side condylar path angle
|
56.75 degrees
Standard Deviation 12.62
|
51.09 degrees
Standard Deviation 9.31
|
|
Condylar Path Angles
Non-pain side condylar path angle
|
44.78 degrees
Standard Deviation 6.87
|
46.18 degrees
Standard Deviation 8.36
|
Adverse Events
Real Occlusal Adjustment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Occlusal Adjustment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Urbano Santana Penín
University of Santiago de Compostela
Phone: 0034647344093
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place