NCT01327157|CompletedResultsDMC

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

Federal University of São Paulo ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

CEP 0323/08

Study Type

interventional

Actual enrollment (reported)

Locations

1 country

Sites

Timeline

Study Start

March 2009

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2010

Actual (reported)

Study Completion

March 2010

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 14 participants
Study completion date: March 2010
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 2009
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
March 2010
Actual (reported)
Study Completion
March 2010
Actual (reported)
First Submitted
March 29, 2011
Actual (reported)
First Posted
April 1, 2011
Actual (reported)
Results Posted
August 20, 2018
Actual (reported)

Last Updated: August 20, 2018
Status Verified: November 2017
Results QC Date: November 5, 2017
Last Update Submitted: November 5, 2017

Conditions

Facial Nerve Diseases Orofacial Pain Peripheral Nerve Facial Nerve Paralysis

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)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Other Outcomes (2)

Study Arms (2)

Visual Analog Scale (VAS)

Occlusal adjustment

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (5)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

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Study Officials

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