Study of a New Technique to Improve the Symptoms of Orofacial Discomfort in Patients With Peripheral Facial Paralysis
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Purpose
- 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.
- gnathostats 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.
| Condition | Intervention |
|---|---|
|
Peripheral Nerve Facial Nerve Paralysis Facial Nerve Diseases Orofacial Pain |
Procedure: occlusal adjustment, Dental cleaning Procedure: Visual analog scale, Dental cleaning |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Neuro Occlusal Rehabilitation in Patient With Peripheral Facial Paralysis - a Randomized Clinical Trial |
- Visual analogue scale (VAS) [ Time Frame: The outcome measure (VAS) will be assessed approximately ninety days after the first query. ] [ Designated as safety issue: No ]
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 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 [ Time Frame: The outcome measure will be evaluated after ninety days from the first consultation ] [ Designated as safety issue: No ]
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.
The dental contacts were evaluated in models and gnathostats demarcated after the points were counted in the models before and after treatment If an increase in the number of dental contacts after occlusal adjustment was detected, in relation of the models.
The models are made in the first and last query, after three visits with one month interval between them by adding three queries.
| Enrollment: | 14 |
| Study Start Date: | March 2009 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: visual analog scale, Dental cleaning
Initial consultation, dental cleaning and performing the visual analog scale. Consultation three months after achieving "visual analog scale" final
|
Procedure: Visual analog scale, Dental cleaning
Initial consultation, dental cleaning and performing the visual analog scale. Consultation three months after achieving "visual analog scale" final
Other Name: Dental cleaning
|
Experimental: occlusal adjustment, VAS
|
Procedure: occlusal adjustment, Dental cleaning
Visual analogue scale, before and after treatment. Dental cleaning at first query. Gnathostats models in the maximal intercuspal position before and after treatment Occlusal adjustment in the teeth that are causing some interference of jaw closure, reaching a maximum contact dental . 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 start to do occlusal adjustment. Will be held palpation of the large muscles, masseter and temporal on both sides and compared with the marks of carbon found in the teeth. After this procedure starts the adjustment following the rules of Guichet
Other Names:
|
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 All patients underwent a dental cleaning in order to blind the study. Seven patients belonged to the control group for three months, 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 tooth cleaning
- Second consultation, after a month, a new visual analog scale.
- Third-query-one months after a new visual analogue scale patient was a three visits with an interval of one month, performing a repeat procedure.
- Treatment group, The researchers applied the technique of Rehabilitation and Neuro Occlusal gnatostaticos models that were made before and after treatment to count the dental contacts.
- First-query-visual analogue scale and tooth cleaning, intervention and preparation of initial models gnatostaticos
- Second-query-after a month, a new visual analogue and intervention.
- Last-query - visual analogue scale and making models gnatostaticos finals. The treatment group had one month to see changes in oral functions.
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| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Brazil | |
| Federal University of São Paulo | |
| São Paulo, Brazil | |
| Principal Investigator: | Rosana Q Costa, master | Federal University of São Paulo |
| Principal Investigator: | Rosana Q Costa, Investigator | Federal University São Paulo |
More Information
Publications:
| Responsible Party: | Pro reitoria de Pos graduação e pesquisa, Federal University of São Paulo |
| ClinicalTrials.gov Identifier: | NCT01327157 History of Changes |
| Other Study ID Numbers: | CEP 0323/08 |
| Study First Received: | March 29, 2011 |
| Last Updated: | March 31, 2011 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Federal University of São Paulo:
|
Facial Paralysis / rehabilitation. Dental Occlusion. Occlusal Adjustment. Malocclusion / therapy. |
Additional relevant MeSH terms:
|
Facies Facial Nerve Diseases Facial Paralysis Bell Palsy Facial Pain Paralysis Disease Attributes Pathologic Processes Cranial Nerve Diseases Nervous System Diseases Mouth Diseases Stomatognathic Diseases Neurologic Manifestations |
Signs and Symptoms Herpesviridae Infections DNA Virus Infections Virus Diseases Pain Salicylic Acid Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Keratolytic Agents Dermatologic Agents |
ClinicalTrials.gov processed this record on May 16, 2013