A clinical trial to comparison the effectiveness of skeletal and dental of palatal expansion after miniscrew-assisted fixed with conventional method in patients who need orthodontic treatment and palatal expansion
Objective: To comparison the effectiveness of skeletal and dental of palatal expansion after miniscrew-assisted fixed with conventional method in patients who need orthodontic treatment and palatal expansion.
Design: A single-blind block randomized clinical trial.
Study population: Patients who need orthodontic treatment and palatal expansion are refereeing to Dental Clinic of Mashhad Faculty of Dentistry.
Inclusion criteria: who need to maxillary arches expand; aged between 12 and 16 years; who show pre-puberty stage (before CS3) based on cervical vertebral stadium (CVS).
Exclusion criteria: In maturity or later of CS3 stages; having certain systemic diseases; using medications that impact on orthopedic and orthodontic response; who patients need to using other appliance (face mask, etc.) simultaneously with expansion appliance.
Sample size: 74 cases.
Study intervention: The control group are revising conventional appliance Hyrax based on dental and intervention group are revising miniscrew-assisted fixed for palatal expansion.
Study outcome: Evaluation and comparison the effectiveness of skeletal and dental including rate of disruption hyoid, rate of tipping crown, gingival recession, fenestration/dehiscence with cone beam computed tomography (CBCT) and root recession with appliance expansion in intervention and control groups 4 months after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017022632787N1
Registration date:2017-03-01, 1395/12/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-03-01, 1395/12/11
Registrant information
Name
Farzane Lale Alizade
Name of organization / entity
Mashhad Faculty of Dentistry
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 3007
Email address
heravif@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to comparison the effectiveness of skeletal and dental of palatal expansion after miniscrew-assisted fixed with conventional method in patients who need orthodontic treatment and palatal expansion
Public title
The effectiveness of skeletal and dental of palatal expansion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: who need to maxillary arches expand; aged between 12 and 16 years; who show pre-puberty stage (before CS3) based on cervical vertebral stadium (CVS).
Exclusion criteria: In maturity or later of CS3 stages; having certain systemic diseases; using medications that impact on orthopedic and orthodontic response; who patients need to using other appliance (face mask, etc.) simultaneously with expansion appliance.
Age
From 12 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
74
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 University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Postal code
Approval date
2015-09-06, 1394/06/15
Ethics committee reference number
IR.mums.sd.REC.1394.55
Health conditions studied
1
Description of health condition studied
Orthodontic treatment and palatal expansion
ICD-10 code
Z51.8
ICD-10 code description
Other specified medical care
Primary outcomes
1
Description
The effectiveness of skeletal and dental including rate of disruption hyoid, rate of tipping crown, gingival recession, fenestration/dehiscence
Timepoint
4 months after intervention
Method of measurement
Cone beam computed tomography (CBCT)
Secondary outcomes
1
Description
Root recession
Timepoint
4 months after intervention
Method of measurement
Appliance expansion
Intervention groups
1
Description
Control group: Who are revising conventional appliance Hyrax based on dental for palatal expansion, the effectiveness of skeletal and dental are examining 4 months after intervention.
Category
Other
2
Description
Intervention group: Who are revising miniscrew-assisted fixed for palatal expansion, the effectiveness of skeletal and dental are examining 4 months after intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Faculty of Dentistry Dental Clinic
Full name of responsible person
Farzane Lale Alizade
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
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 for Research, Mashhad University of Medical Sciences
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
Mashhad Faculty of Dentistry
Full name of responsible person
Farzin Heravi
Position
Orthodontics
Other areas of specialty/work
Street address
Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Postal code
Phone
+98 51 3806 7224
Fax
Email
farzinheravi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad Faculty of Dentistry
Full name of responsible person
Farzane Lale Alizade
Position
Orthodontics
Other areas of specialty/work
Street address
Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Postal code
Phone
+98 51 3806 7224
Fax
Email
fla7989@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad Faculty of Dentistry
Full name of responsible person
Farzane Lale Alizade
Position
Orthodontics
Other areas of specialty/work
Street address
Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Postal code
Phone
+98 51 3806 7224
Fax
Email
farzinheravi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)