Comparing the relaxation effect of diazepam of oral administration of single and divided dose in Patients with limited mouth opening origin of masticatory muscles
The patients with limitation in mouth opening have some problems in eating and speaking. Therefore, getting impressions for their oral appliance therapy is often impossible and the dentists use other treatment to reach the appropriate mouth opening. Benzodiazepines are a group of drugs which use as muscle relaxants. However Diazpam is commonly used for muscle relaxing by the central effect, but there is no certain research on its dosage and mode of administration for the muscle of mastication. Diazpam has a high kinetic lifetime, but its effect on the CNS is low due to high lipophilic condition (It quickly enters to CNS and exits). So if we increase the number of doses, its effectiveness may be improved.
The aim of this study is a comparison of muscle relaxation in patients with limitation in mouth opening that use single or divided dose of Diazpam. 48 patients with limitation in mouth opening in the range of 8-10 mm with the origin of masticatory muscles are assigned to three groups randomly. The first group used up a dose of 10 mg, the second group used up two dose of 5 mg and the third group used up four dose of 2.5 mg Diazpam daily. The rage of mouth opening (from incisal edge of the right centrals) will be measured in millimeter and the pain during the mouth opening will be scaled on the VAS before and after using the drugs in the third, fifth and seventh days.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017032933167N1
Registration date:2017-05-15, 1396/02/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-15, 1396/02/25
Registrant information
Name
Neda Jarahi
Name of organization / entity
Mashhad University of Medical Science(MUMS)
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9501
Email address
jarrahin921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor Of Research, Mashhad University of Medical Science
Expected recruitment start date
2017-04-30, 1396/02/10
Expected recruitment end date
2018-05-31, 1397/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the relaxation effect of diazepam of oral administration of single and divided dose in Patients with limited mouth opening origin of masticatory muscles
Public title
Comparing the relaxation effect of diazepam of oral administration of single and divided dose in Patients with limited mouth opening origin of masticatory muscles
Purpose
Treatment
Inclusion/Exclusion criteria
Exclusion criteria:Pregnancy:Breastfeeding;using Drugs have interactions with diazepam (such as cimetidine, Amvprazvl, phenytoin, erythromycin and fungicides);Liver and kidney disfunctions (with tests SGOT, SGPT, ALP, Bun-Creatinine); alcoholism; glaucoma; severe difficulty breathing; Sleep Apnea; Epilepsy;Consumers of other benzodiazepines; other muscle relaxants and anti-inflammatory drugs; close lock; the joint disorders; chronic slow mandible; patients with submucosal fibrosis; patients radiotherapy; Sensitivity to diazepam
Inclusion criteria:;Patients with limitation in mouth opening by the source of masticatory muscle
Age
From 16 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad Dental Faculty
Street address
Opposite Melat Park.Mashhad
City
Mashhad
Postal code
Approval date
2017-03-15, 1395/12/25
Ethics committee reference number
IR.mums.sd.REC.1394.213
Health conditions studied
1
Description of health condition studied
limitation of mouth opening due to masticatory muscles
ICD-10 code
XIII
ICD-10 code description
Diseases of the musculoskeletal system and connective tissue
Primary outcomes
1
Description
range of mouth opening
Timepoint
before Intervention and in 3,5 and 7 days after Intervention
Method of measurement
the distance between inscisal edge of two right centrals in milimeter
Secondary outcomes
1
Description
pain through opening
Timepoint
before Intervention and in 3,5 and 7 days after Intervention
Method of measurement
VAS(visual analog scale)
2
Description
drug complications
Timepoint
before Intervention and in 3,5 and 7 days after Intervention
Method of measurement
patient's discription
Intervention groups
1
Description
oral diazepam 10 mg/ 1 tab daily
maximum for 1 week
Category
Treatment - Drugs
2
Description
oral diazepam 5 mg/ 2 tab daily
maximum for 1 week
Category
Treatment - Drugs
3
Description
oral diazepam 2.5 mg/ 4 tab daily
maximum for 1 week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Faculty of Mashhad
Full name of responsible person
Neda Jarahi
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor Of Research, Mashhad University of Medical Science
Full name of responsible person
ََAzam Sadat Madani
Street address
Vice Chancellor Of Research, Mashhad University of Medical Science
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor Of Research, Mashhad University of Medical Science
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
Dental Faculty of Mashhad University
Full name of responsible person
Neda Jarahi
Position
Prosthodontics Resident
Other areas of specialty/work
Street address
Opposit Mellat park,Vakil abad boulevard,
City
Mashhad
Postal code
Phone
+98 38067117
Fax
Email
jarrahin921@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental Faculty of Mashhad
Full name of responsible person
Azam Sadat Madani
Position
Professor
Other areas of specialty/work
Street address
Opposit Mellat park,Vakil Abad Boulevard,
City
Mashhad
Postal code
Phone
+98 51 3768 5758
Fax
Email
madania@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Science
Full name of responsible person
Neda Jarrahi
Position
Resident of Prosthesis
Other areas of specialty/work
Street address
Vakil abad boulevard, Mashhad University of Medical Science
City
Mashhad
Postal code
Phone
+98 515220729
Fax
Email
jarrahin921@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)