This study aimed to assess the efficacy of elimination of oral parafunctional habits for improvement of TMDs and neck pain.
This interventional study was conducted on 136 patients presenting to the oral medicine department from January 2012 to January 2014 who had TMD, parafunctional habits and neck pain according to the Helkimo’s index and the neck pain and disability index (NPDI). Patients were instructed on how to quit their parafunctional habits and were followed up at one and two months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201410091559N6
Registration date:2016-02-18, 1394/11/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-18, 1394/11/29
Registrant information
Name
Farzaneh Aghahoseini
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6611 2437
Email address
aghahose@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Oral and Maxillofacial Medicine Departments of Tehran University of Medical Sciences
Expected recruitment start date
2013-01-09, 1391/10/20
Expected recruitment end date
2015-01-25, 1393/11/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Parafunctional Habitual Deletion in Improvement of Patient with Temporomandibular Joint Disorder and Neck Pain
Public title
Elimination of Parafunctional Habits for Treatment of Temporomandibular Disorders and Neck Pains
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients who had TMDs according to the Helkimo’s index; Patients who had parafunctional habits along with TMDs; Patients who had neck pain according to the criteria described by NPDI; Subjects between 15 to 75 years;
Exclusion criteria: Subjects who only had TMDs or neck pain; Subjects younger than 15 or older than 75 years; Subjects with a history of trauma to their neck or TMJs; Subjects who were under regular pharmaceutical therapy for TMDs and neck pain.
Age
From 15 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
136
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shcool of Dentistry, Tehran Univrsity of Medical Sciences
Street address
School of Dentistry, Tehran University of Medical Sciences, North Karegar St., Enghelab Sq., Tehran.
City
Tehran
Postal code
Approval date
2015-12-21, 1394/09/30
Ethics committee reference number
IR.Tums.REC.139401451
Health conditions studied
1
Description of health condition studied
TMD, Neck pain
ICD-10 code
K07.6, S14
ICD-10 code description
Temporomandibular joint disorders, Injury of cervical sympathetic nerves
Primary outcomes
1
Description
TMD
Timepoint
at the time of intervention,,1months after intervention...and 2months after intervention
Method of measurement
Helkimo index
Secondary outcomes
1
Description
Neck pain
Timepoint
at the time of intervention,,1month after intervention...and 2months after intervention
Method of measurement
NPDI index
Intervention groups
1
Description
Patients were instructed to place their tongue behind their maxillary central incisors in such a way that the tongue applied no pressure to oral and dental tissues (as when the letter N is pronounced). In this position, the distance between the upper and lower teeth must be a few millimeters and lips must be closed with minimal pressure. In this position, the freeway space is maintained.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Oral and Maxillofacial Medicine Departments of Tehran University of Medical Sciences
Full name of responsible person
ٍElahe Mostajir
Street address
School of Dentistry, Tehran University of Medical Sciences, North Karegar St., Enghelab Sq., Tehran.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Center of School of Dentistry, Tehran University of Medical Seiences
Full name of responsible person
Dr. Zahra Khorshidi
Street address
Research Center of School of Dentistry, Tehran University of Medical Sciences, Enghelab Sq., Tehran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Center of School of Dentistry, Tehran University of Medical Seiences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Student
Full name of responsible person
Elahe Mostajir
Position
School of Dentistry , Tehran University of Medical Sciences.
Other areas of specialty/work
Street address
School of Dentistry, Tehran University of Medical Sciences, North Karegar St., Enghelab Sq., Tehran.