Study of a New Technique to Improve the Symptoms of Orofacial Discomfort in Patients With Peripheral Facial Paralysis

This study has been completed.
Sponsor:
Collaborator:
School of Medicine Hospital, Sao Paulo
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01327157
First received: March 29, 2011
Last updated: March 31, 2011
Last verified: March 2011
  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

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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

  • VAS at the first inquiry
  • VAS at the last inquiry
  • dental cleaning in the first inquiry
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

  • VAS at the first inquiry
  • VAS at the last inquiry
  • dental cleaning in the first inquiry
Other Name: Dental cleaning
Experimental: occlusal adjustment, VAS
  • in all consultations, was performed the VAS
  • approximately one month after another scale was performed visual analogic and other intervention
  • were three sessions of intervention
  • gnathostats models were performed in the first and last query
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:
  • Occlusal adjustment
  • VAS
  • Dental cleaning

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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01327157

Locations
Brazil
Federal University of São Paulo
São Paulo, Brazil
Sponsors and Collaborators
Federal University of São Paulo
School of Medicine Hospital, Sao Paulo
Investigators
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
Paralysis
Nervous System Diseases
Facial Paralysis
Bell Palsy
Facial Nerve Diseases
Disease Attributes
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Mouth Diseases
Stomatognathic Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Cranial Nerve Diseases
Salicylic Acid
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on October 02, 2014