Clinical trial NCT01327157: Study of a New Technique to Improve the Symptoms of Orofacial Discomfort in Patients With Peripheral Facial Paralysis
Official title: Neuro Occlusal Rehabilitation in Patient With Peripheral Facial Paralysis - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Nerve Facial Nerve Paralysis
Facial Nerve Diseases
Orofacial Pain
Keywords: Facial Paralysis / rehabilitation.
Dental Occlusion.
Occlusal Adjustment.
Malocclusion / therapy.
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2011-04-01
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Day 1 (Day 91 for Treatment participants first receiving Placebo)
measure: Brand Carbon Count on Gnathostats Models
timeFrame: Day 01 and after 90 days of treatment (Day 180 for Treatment participants first receiving Placebo)
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: After 90 days of treatment (Day 180 for Treatment participants first receiving Placebo)
Other outcomes:
measure: Correlation Between the Increase of the Number of Dental Contact Points and the Improvement in the Subjective Evaluation Measured Through the Visual Analogic Scale .
timeFrame: Day 01 and after 90 days of treatment (Day 180 for Treatment participants first receiving Placebo)
measure: 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.
timeFrame: Day 01 and after 90 days of treatment (Day 180 for Treatment participants first receiving Placebo)
Locations:
city: São Paulo
country: Brazil
facility: Federal University of São Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Rosana Q Costa, master
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University São Paulo
name: Rosana Q Costa, Investigator
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rahal A, Goffi-Gomez MV. Clinical and electromyographic study of lateral preference in mastication in patients with longstanding peripheral facial paralysis. Int J Orofacial Myology. 2009 Nov;35:19-32.
citation: Martin E. [Neuro-occlusal rehabilitation and selective grinding: results after 1 year]. Orthod Fr. 2000 Jan;71(1):57-60. French.
citation: Planas P. [Equilibrium and neuro-occlusal rehabilitation]. Orthod Fr. 1992;63 Pt 2:435-41. French.
citation: Planas M. [Neuro-occlusal rehabilitation: NOR]. Orthod Fr. 1971;42:333-47. No abstract available. French.
citation: Christensen LV, Radue JT. Lateral preference in mastication: an electromyographic study. J Oral Rehabil. 1985 Sep;12(5):429-34. doi: 10.1111/j.1365-2842.1985.tb01548.x.