Trial Outcomes & Findings for Study of a New Technique to Improve the Symptoms of Orofacial Discomfort in Patients With Peripheral Facial Paralysis (NCT NCT01327157)
NCT ID: NCT01327157
Last Updated: 2018-08-20
Results Overview
It is a scale-shaped ruler, which is associated with faces used to grade the degree of pain for patients, before and after treatments, or just graduating pain and its severity for the patient (Souza, 2002). Patients were asked to fill the VAS with the following questions. * Do you chew well? * How would you classify your chewing at the moment? * If you have no trouble chewing, the rating is zero. * If you have any discomfort when you chew, your reference level is five. * If the discomfort is intense, its reference level is ten. The greater the discomfort, the greater the scale.
COMPLETED
NA
14 participants
Day 1 (Day 91 for Treatment participants first receiving Placebo)
2018-08-20
Participant Flow
There was a selection of sixty-five patients with traumatic and idiopathic palsy of the Otorhinolaryngology UNIFESP, between June 2008-March 2009, according to the criteria of inclusion and exclusion, resultram forty-four, of whom 30 did not participate, resulting in 14.
Some patients were excluded because they did not agree to be randomized, others could not be present at every visit, or were co-interventions.
Participant milestones
| Measure |
Placebo Then Treatment
Participants recived, Dental cleaning and performing the visual analog scale, durant tree visits.
At first visit was doing Dental cleaning and visual analog scale and after 90 days was doing another visual analog scale.
Participants who recieved Placebo later recieved Treatment as described for The experimental-Occlusal Adjustment Arm.
|
Experimental-Occlusal Adjustment
Participants recived, Dental cleaning, occlusal adjustment, and visual analog scale and gnathostatic models in the first visit.
After three times, consecutively, one visit a month, the intervention was performed. At the first visit and after 90 days, visual analog scale, and gnathostatic models, were performed.
|
|---|---|---|
|
01-90
STARTED
|
7
|
7
|
|
01-90
COMPLETED
|
7
|
7
|
|
01-90
NOT COMPLETED
|
0
|
0
|
|
91-180
STARTED
|
7
|
0
|
|
91-180
COMPLETED
|
7
|
0
|
|
91-180
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of a New Technique to Improve the Symptoms of Orofacial Discomfort in Patients With Peripheral Facial Paralysis
Baseline characteristics by cohort
| Measure |
Control Group-visual Analog Scale (EVA), Dental Cleaning
n=7 Participants
Dental cleaning and performing the visual analog scale. At first visit was doing Dental cleaning and visual analog scale and after 90 days was doing another visual analog scale.
|
Treatment Group-EVA,Dental Cleaning,Occlusal Adjustment.
n=7 Participants
Dental cleaning, occlusal adjustment, and visual analog scale and gnathostatic models was doing in the intervention group, at the first visit and after 90 days, visual analog scale, and gnathostatic models.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.6 years
STANDARD_DEVIATION 9.8 • n=99 Participants
|
36.4 years
STANDARD_DEVIATION 9.2 • n=107 Participants
|
36.42 years
STANDARD_DEVIATION 9.13 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Cause of facial paralysis
Traumatic
|
4 participants
n=99 Participants
|
3 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Cause of facial paralysis
Idiopatic
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
7 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1 (Day 91 for Treatment participants first receiving Placebo)Population: All participants were treated by intention to treat.
It is a scale-shaped ruler, which is associated with faces used to grade the degree of pain for patients, before and after treatments, or just graduating pain and its severity for the patient (Souza, 2002). Patients were asked to fill the VAS with the following questions. * Do you chew well? * How would you classify your chewing at the moment? * If you have no trouble chewing, the rating is zero. * If you have any discomfort when you chew, your reference level is five. * If the discomfort is intense, its reference level is ten. The greater the discomfort, the greater the scale.
Outcome measures
| Measure |
Placebo-VAS, Dental Cleaning
n=7 Participants
Dental cleaning and performing the visual analog scale. At first visit (day 1) was doing Dental cleaning and visual analog scale.
|
Treatment- VAS,Dental Cleaning,Occlusal Adjustment.
n=14 Participants
Dental cleaning, occlusal adjustment, visual analog scale and gnathostatic models was doing in the intervention group, at the first visit.(day 1). After day 90,the control group passed to treatment group, (day 91)and start the treatment and was done dental cleaning, occlusal adjustment, visual analog scale, and gnatostatic models.
|
|---|---|---|
|
The Visual Analog Scale for Pain Was Used to Grade Discomfort in Chewing After the Installation of Facial Paralysis. Level Zero is the Lack of Discomfort and 10 is the Maximum Degree of Discomfort.
|
5.6 units on a scale
Standard Deviation 1.1
|
6.1 units on a scale
Standard Deviation 1.8
|
PRIMARY outcome
Timeframe: Day 01 and after 90 days of treatment (Day 180 for Treatment participants first receiving Placebo)Only in the treatment group were done gnatostatic models.The models were placed occluding brought with carbon, using the willis compass to keep occluding the posterior base of the model which are aligned with the rear. A model of the teeth was made to measure the occlusion of the teeth (i.e., the amount of contact between the upper and lower mandibles), and used carbon to count the the number of dental contacts, through the brand carbon made on the model, The dental contacts were counted in the models before and after treatment. The models are made in the first and last query.
Outcome measures
| Measure |
Placebo-VAS, Dental Cleaning
n=14 Participants
Dental cleaning and performing the visual analog scale. At first visit (day 1) was doing Dental cleaning and visual analog scale.
|
Treatment- VAS,Dental Cleaning,Occlusal Adjustment.
n=14 Participants
Dental cleaning, occlusal adjustment, visual analog scale and gnathostatic models was doing in the intervention group, at the first visit.(day 1). After day 90,the control group passed to treatment group, (day 91)and start the treatment and was done dental cleaning, occlusal adjustment, visual analog scale, and gnatostatic models.
|
|---|---|---|
|
Brand Carbon Count on Gnathostats Models
|
9.6 number of dental contacts
Standard Deviation 3.0
|
14.6 number of dental contacts
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: After 90 days of treatment (Day 180 for Treatment participants first receiving Placebo)It is a scale-shaped ruler, which is associated with faces used to grade the degree of pain for patients, before and after treatments, or just graduating pain and its severity for the patient (Souza, 2002). Patients were asked to fill the VAS with the following questions. Do you chew well? How would you classify your chewing at the moment? If you have no trouble chewing, the rating is zero. If you have any discomfort when you chew, your reference level is five. If the discomfort is intense, its reference level is ten. The greater the discomfort, the greater the scale.
Outcome measures
| Measure |
Placebo-VAS, Dental Cleaning
n=7 Participants
Dental cleaning and performing the visual analog scale. At first visit (day 1) was doing Dental cleaning and visual analog scale.
|
Treatment- VAS,Dental Cleaning,Occlusal Adjustment.
n=14 Participants
Dental cleaning, occlusal adjustment, visual analog scale and gnathostatic models was doing in the intervention group, at the first visit.(day 1). After day 90,the control group passed to treatment group, (day 91)and start the treatment and was done dental cleaning, occlusal adjustment, visual analog scale, and gnatostatic models.
|
|---|---|---|
|
Visual Analog Scale
|
5.4 units on a scale
Standard Deviation 1.3
|
3.0 units on a scale
Standard Deviation 1.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 01 and after 90 days of treatment (Day 180 for Treatment participants first receiving Placebo)The correlation between the increase of the number of the dental contacts and the VAS evaluation final result from chronic peripheral facial paralysis patients, according to control and treated groups by the neuro occlusal rehabilitation technic.
Outcome measures
| Measure |
Placebo-VAS, Dental Cleaning
n=14 Participants
Dental cleaning and performing the visual analog scale. At first visit (day 1) was doing Dental cleaning and visual analog scale.
|
Treatment- VAS,Dental Cleaning,Occlusal Adjustment.
Dental cleaning, occlusal adjustment, visual analog scale and gnathostatic models was doing in the intervention group, at the first visit.(day 1). After day 90,the control group passed to treatment group, (day 91)and start the treatment and was done dental cleaning, occlusal adjustment, visual analog scale, and gnatostatic models.
|
|---|---|---|
|
Correlation Between the Increase of the Number of Dental Contact Points and the Improvement in the Subjective Evaluation Measured Through the Visual Analogic Scale .
|
0.111 correlation coefficient
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 01 and after 90 days of treatment (Day 180 for Treatment participants first receiving Placebo)The correlation between the increase of the number of the dental contacts and VAS evaluation final result from chronic peripheral facial paralysis patients. On this measure was excluded one outlier patient whose facial paralysis appeared in her childhood. Observing the outlier patient, it was carried out a new scatterplot, ignoring her.
Outcome measures
| Measure |
Placebo-VAS, Dental Cleaning
n=13 Participants
Dental cleaning and performing the visual analog scale. At first visit (day 1) was doing Dental cleaning and visual analog scale.
|
Treatment- VAS,Dental Cleaning,Occlusal Adjustment.
Dental cleaning, occlusal adjustment, visual analog scale and gnathostatic models was doing in the intervention group, at the first visit.(day 1). After day 90,the control group passed to treatment group, (day 91)and start the treatment and was done dental cleaning, occlusal adjustment, visual analog scale, and gnatostatic models.
|
|---|---|---|
|
Correlation Between the Increase of the Number of Dental Contact Points and the Improvement in the Subjective Evaluation Measured Through the Visual Analogic Scale Whithout the Outlier.
|
0.638 correlation coefficient
|
—
|
Adverse Events
Visual Analog Scale, Dental Cleaning
Visual Analog Scale,Dental Cleaning,Occlusal Adjustment.
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dra Rosana de Queiroz Costa
Master-Pos graduação em Otorrinolaringologia
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place