Facial Nerve Diseases, Orofacial Pain, Peripheral Nerve Facial Nerve Paralysis
Conditions
Keywords
Facial Paralysis / rehabilitation., Dental Occlusion., Occlusal Adjustment., Malocclusion / therapy.
Brief summary
* The purpose of this study was to evaluate the effects of Neuro Occlusal Rehabilitation (RNO) in patients with peripheral facial palsy (PFP) disease, noting the decrease in symptoms of masticatory dysfunction. * According to Carvalho (2009) patients with PFP have chronic unilateral masticatory preference. Santos et al. (2009) in the same year noted that these conditions can lead to problems with temporomandibular disorder. * Hypothesis- known that performing occlusal adjustment in these patients with chronic PFP, ensuring a maximum of dental contacts and a final stop of the masticatory cycle stable, providing a balanced occlusion. * dental cleaning was performed in two groups for the blind study * visual analog scale -To assess the quality of the oral functions of these patients, the investigators applied the visual analog scale(VAS) and statistically evaluated the degree of satisfaction regarding the functions of oro facial in relation to mastication and temporomandibular dysfunction. * gnathostatic models were made in the treatment group in the first and last query. * occlusal adjustment in treatment group.In the group treated occlusal adjustment was made in the teeth and applied a new (VAS) before and after treatment. The RNO, is defined as a part of medicine that operates in stomatology occlusal plane as a guide to a harmonious development of the face, chewing facilitating bilateral and alternating. (Planas, 1997). It works through selective grinding on the occlusal platform, providing an increased number of dental contacts.
Detailed description
Purpose: To evaluate the effects of the Neuro-Rehabilitation occlusion in patients with chronic facial palsy by observing the decrease of the symptoms of masticatory dysfunction. Methods: a selection of sixty-five patients with facial palsy (PFP 65) and idiopathic chronic trauma of the Otorhinolaryngology sector facial nerve disorders at UNIFESP. Patients were of both genders, aged between 18 and 60. They were analyzed according to the criteria of inclusion and exclusion, resulting in forty-three patients. However, due to problems inherent in research, a group of fourteen patients were randomized (sub-divided) into two groups: control and treatment. The visual analog scale was used at the first consultation to patients in the control and treatment group. All patients underwent a dental cleaning in order to blind the study. Seven patients belonged to the control group for three months per sequence, the VAS was performed in both groups. The control group was later reunited with the treatment group after three months of control period, increasing the number of patients who were examined in extracts, with similar features in a prognostic factor. * Control group * First visit- visual analogue scale and dental cleaning - Day 1 * Second visit, after a month, a new visual analog scale. Day-30 * Third-visit -one months after a new visual analogue scale Day 60 patient was a three visits with an interval of one month, performing a repeat procedure. * Last visit - Day 90 visual analogue scale * Treatment group The researchers applied the technique of Rehabilitation and Neuro Occlusal gnathostatic models that were made before and after treatment to count the dental contacts. * First query - visual analogue scale and dental cleaning, preparation of initial models gnatostaticos and intervention- Day 1 * Second-query-after a month, a new visual analogue and intervention. Day 30 * Third query- -after a month, a new visual analogue and intervention Day 60 * Last query -after a month a new visual analogue scale and making models gnathostatic finals. Day 90 The treatment group had one month to see changes in oral functions, but for estatistic effects was computed only de first andy the last visit the number of the dental contact and the VAS. Day 90 Upon completion of the study patients continued to receive care in the ambulatory clinic of the university, but the attendance for this research was terminated.
Interventions
PROCEDUREocclusal adjustment.
It prompted the patient to perform the act of swallowing for 3 times to reach a terminal axis of rotation of the jaw and from this to start. Will be held palpation of the muscles, masseter and temporal on both sides and compared with the marks of carbon found in the teeth. After starts the adjustment following the rules of Guichet with a cylindrical drill with a thin cut . basic principles 1 Occlusive stress maximum distribution in centric relation 2 The occlusive strengths should by the teeth's major axis.3 When the contact is surface to surface, it must be exchanged to another surface point. 4 Once the stability to the centric relation is achieved, it should be kept. The rules to guide the occlusal adjustment selective grinding .
BEHAVIORALVisual analog scale.
Visual analog scale-Graduation was held on the visual analogue scale in the first and last query to measure discomfort chewing.Graduation was held on the visual analogue scale .in the first and last query to measure discomfort chewing. After graduating dental cleaning was performed, with the purpose of blinding the study, Dental Cleaning.With engine using low speed, brushes, and prophylactic paste is carried out dental cleaning in the teeth of all patient. Dental Cleaning.With engine using low speed, brushes, and prophylactic paste is carried out dental cleaning in the teeth of all patient.
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* patients with PFP over six months of treatment * indentations * carrier fixed partial dentures and removable drives and/or dental implants * palsy classified as Grade III according to House and Brackmann scale
Exclusion criteria
* patients who already had other diseases in the region of the jaws before facial paralysis * is toothless from installing, using or not dentures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Day 1 (Day 91 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. |
| Brand Carbon Count on Gnathostats Models | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between the Increase of the Number of Dental Contact Points and the Improvement in the Subjective Evaluation Measured Through the Visual Analogic Scale . | 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. |
| 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. | 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. |
Countries
Brazil
Participant flow
Recruitment details
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.
Pre-assignment details
Some patients were excluded because they did not agree to be randomized, others could not be present at every visit, or were co-interventions.
Participants by arm
| Arm | Count |
|---|---|
| Control Group-visual Analog Scale (EVA), Dental Cleaning 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. | 7 |
| Treatment Group-EVA,Dental Cleaning,Occlusal Adjustment. 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. | 7 |
| Total | 14 |
Baseline characteristics
| Characteristic | Control Group-visual Analog Scale (EVA), Dental Cleaning | Treatment Group-EVA,Dental Cleaning,Occlusal Adjustment. | Total |
|---|---|---|---|
| Age, Continuous | 36.6 years STANDARD_DEVIATION 9.8 | 36.4 years STANDARD_DEVIATION 9.2 | 36.42 years STANDARD_DEVIATION 9.13 |
| Cause of facial paralysis Idiopatic | 3 participants | 4 participants | 7 participants |
| Cause of facial paralysis Traumatic | 4 participants | 3 participants | 7 participants |
| Sex: Female, Male Female | 6 Participants | 1 Participants | 7 Participants |
| Sex: Female, Male Male | 1 Participants | 6 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 14 |
| other Total, other adverse events | 0 / 7 | 0 / 14 |
| serious Total, serious adverse events | 0 / 7 | 0 / 14 |
Outcome results
Primary
Brand Carbon Count on Gnathostats Models
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.
Time frame: Day 01 and after 90 days of treatment (Day 180 for Treatment participants first receiving Placebo)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo-VAS, Dental Cleaning | Brand Carbon Count on Gnathostats Models | 9.6 number of dental contacts | Standard Deviation 3 |
| Treatment- VAS,Dental Cleaning,Occlusal Adjustment. | Brand Carbon Count on Gnathostats Models | 14.6 number of dental contacts | Standard Deviation 4.4 |
Comparison: The brand carbon mark was done on the treatment group in the first and last query.p-value: <0.001t-test, 2 sided
Primary
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.
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.
Time frame: Day 1 (Day 91 for Treatment participants first receiving Placebo)
Population: All participants were treated by intention to treat.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo-VAS, Dental Cleaning | 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 |
| Treatment- VAS,Dental Cleaning,Occlusal Adjustment. | 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. | 6.1 units on a scale | Standard Deviation 1.8 |
Comparison: We assessed the quality of oral functions in the first query to check the status of discomfort before treatment in both groups, using VAS..~Statistical significance was considered for values of p \<0.05 and it was used The Minitab statistical software, version 15.1 to obtain the resultsp-value: 0.524t-test, 1 sided
Secondary
Visual Analog Scale
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.
Time frame: After 90 days of treatment (Day 180 for Treatment participants first receiving Placebo)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo-VAS, Dental Cleaning | Visual Analog Scale | 5.4 units on a scale | Standard Deviation 1.3 |
| Treatment- VAS,Dental Cleaning,Occlusal Adjustment. | Visual Analog Scale | 3.0 units on a scale | Standard Deviation 1.5 |
Comparison: We assessed the quality of oral functions in the last query to check the status of discomfort after ninety days in both groups, control and treatment, using VAS.~The statistical significance was considered to p\<0.05 values and it was used the Minitab statistics software, 15.1 version, to get the results.p-value: 0.002t-test, 2 sided
Other Pre-specified
Correlation Between the Increase of the Number of Dental Contact Points and the Improvement in the Subjective Evaluation Measured Through the Visual Analogic Scale .
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.
Time frame: Day 01 and after 90 days of treatment (Day 180 for Treatment participants first receiving Placebo)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo-VAS, Dental Cleaning | 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 |
p-value: 0.705t-test, 1 sided
Other Pre-specified
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.
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.
Time frame: Day 01 and after 90 days of treatment (Day 180 for Treatment participants first receiving Placebo)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo-VAS, Dental Cleaning | 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 |
p-value: 0.01t-test, 1 sided