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

Neuro Occlusal Rehabilitation in Patient With Peripheral Facial Paralysis - a Randomized Clinical Trial

• 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.

Study Overview

• Status: Completed
• Conditions: Facial Nerve Diseases; Orofacial Pain; Peripheral Nerve Facial Nerve Paralysis
• Intervention / Treatment: Behavioral: Visual analog scale.; Procedure: occlusal adjustment.

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • Federal University of São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Visual Analog Scale (VAS); Initial consultation, dental cleaning and performing the visual analog scale. Consultation three months after achieving "visual analog scale" final; VAS and dental cleaning at the first query.; VAS at the last query. In the second period (91-180 days) that participants have been moved from the Placebo group (VAS) to the Experimental group(Occlusal Adjustment).	Behavioral: Visual 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.
Experimental: Occlusal adjustment; In all consultations, was performed VAS and occlusal adjustment. Three sessions of intervention are doing. The Gnathostatic models were performed in the first and last query. To reach a terminal axis of rotation of the jaw the patient to perform the act of swallowing for 3 times, and after palpation of the muscles, masseter and temporal on both sides and compared with the marks of carbon found in the teeth and started the adjustment following the rules of Guichet with a cylindrical drill with a thin cut.. The rules to guide the occlusal adjustment selective grinding were in this sequence: Occlusal adjustment to the centric relation: with sliding towards anterior; with sliding towards the medium line; with sliding opposite to the medium line; No sliding.	Behavioral: Visual 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.; Procedure: occlusal 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1 (Day 91 for Treatment participants first receiving Placebo)
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.	Day 01 and after 90 days of treatment (Day 180 for Treatment participants first receiving Placebo)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After 90 days of treatment (Day 180 for Treatment participants first receiving Placebo)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 01 and after 90 days of treatment (Day 180 for Treatment participants first receiving Placebo)
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.	Day 01 and after 90 days of treatment (Day 180 for Treatment participants first receiving Placebo)

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Investigators: Principal Investigator: Rosana Q Costa, master, Federal University of São Paulo; Principal Investigator: Rosana Q Costa, Investigator, Federal University São Paulo

Publications and helpful links

General Publications

• 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.
• Martin E. [Neuro-occlusal rehabilitation and selective grinding: results after 1 year]. Orthod Fr. 2000 Jan;71(1):57-60. French.
• Planas P. [Equilibrium and neuro-occlusal rehabilitation]. Orthod Fr. 1992;63 Pt 2:435-41. French.
• Planas M. [Neuro-occlusal rehabilitation: NOR]. Orthod Fr. 1971;42:333-47. No abstract available. French.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: March 29, 2011
• First Submitted That Met QC Criteria: March 31, 2011
• First Posted (Estimate): April 1, 2011

Study Record Updates

• Last Update Posted (Actual): August 20, 2018
• Last Update Submitted That Met QC Criteria: November 5, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Facial Paralysis / rehabilitation.; Dental Occlusion.; Occlusal Adjustment.; Malocclusion / therapy.
• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Infections; Pain; Neurologic Manifestations; Disease Attributes; Stomatognathic Diseases; Mouth Diseases; DNA Virus Infections; Cranial Nerve Diseases; Herpesviridae Infections; Nervous System Diseases; Paralysis; Facial Pain; Bell Palsy; Facial Paralysis; Facies; Facial Nerve Diseases; Anti-Infective Agents; Dermatologic Agents; Antifungal Agents; Keratolytic Agents; Salicylic Acid
• Other Study ID Numbers: CEP 0323/08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO