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

NCT01327157 | Completed Results DMC

• 1 other identifier: CEP 0323/08
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Nerve Facial Nerve Paralysis; Facial Nerve Diseases; Orofacial Pain

Keywords

Facial Paralysis / rehabilitation.; Dental Occlusion.; Occlusal Adjustment.; Malocclusion / therapy.

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Visual Analog Scale

  After 90 days of treatment (Day 180 for Treatment participants first receiving Placebo)

Other Outcomes (2)

• 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)

• 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)

Study Arms (2)

Visual Analog Scale (VAS)

PLACEBO COMPARATOR

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.

Occlusal adjustment

EXPERIMENTAL

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.

Procedure: occlusal adjustment.; Behavioral: Visual analog scale.

Interventions

occlusal adjustment. PROCEDURE

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 .

Occlusal adjustment

Visual analog scale. BEHAVIORAL

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.

Occlusal adjustment; Visual Analog Scale (VAS)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• patients who already had other diseases in the region of the jaws before facial paralysis
• is toothless from installing, using or not dentures

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of São Paulo

São Paulo, Brazil

Location

Related Publications (5)

• 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.

  PMID: 20572435 BACKGROUND

• Martin E. [Neuro-occlusal rehabilitation and selective grinding: results after 1 year]. Orthod Fr. 2000 Jan;71(1):57-60. French.

  PMID: 10838864 BACKGROUND

• Planas P. [Equilibrium and neuro-occlusal rehabilitation]. Orthod Fr. 1992;63 Pt 2:435-41. French.

  PMID: 1341730 BACKGROUND

• Planas M. [Neuro-occlusal rehabilitation: NOR]. Orthod Fr. 1971;42:333-47. No abstract available. French.

  PMID: 5293022 BACKGROUND

• 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.

  PMID: 3862802 BACKGROUND

MeSH Terms

Conditions

Facial Nerve Diseases; Facial Pain; Facial Paralysis; Bites and Stings; Malocclusion

Interventions

Occlusal Adjustment

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis; Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Tooth Diseases

Intervention Hierarchy (Ancestors)

Orthodontics, Corrective; Orthodontics; Dentistry

Results Point of Contact

• Title: Dra Rosana de Queiroz Costa
• Organization: Master-Pos graduação em Otorrinolaringologia

rosanaqueiroz@msn.com

55___11___98579-8799

Study Officials

• Rosana Q Costa, master

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

• Rosana Q Costa, Investigator

  Federal University São Paulo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rosana de Queiroz Costa

Study Record Dates

• First Submitted: March 29, 2011
• First Posted: April 1, 2011
• Study Start: March 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: August 20, 2018
• Results First Posted: August 20, 2018

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)