Evaluation of dental & skeletal changes following surgically assisted maxillary
expansion with or without pterygomaxillary disjunction, and their long-term stability
The aim of this study is to evaluate the skeletal and dental changes following surgically assisted maxillary expansion with or without pterygomaxillary disjunction, and their long-term stability. We perform this study on 30 Patients aged 15 to 35 years old with narrow maxilla who are referred by orthodontists for palatal expansion. Patients with a history of surgical or orthodontic treatment on maxilla, Patients with cleft lip and/or palate anomalies, syndromic patients and patients taking any drug for a long time are excluded from this study. We perform surgically assisted maxillary expansion without pterygomaxillary disjunction on 15 consecutive patients with narrow maxilla and compare them with 15 patients who have been involved in another clinical trial study (Irct registration number: IRCT138904124303N1) and have had a surgically assisted maxillary expansion with pterygomaxillary disjunction. Using CBCT, variables are measured before treatment, and 4 and 12 months after treatment. The following variables are measured in this study: 1) Maxillary width 2) Tipping of maxillary posterior teeth 3) Thickness of bone overlaying roots of posterior maxillary teeth 4) Width of floor of the nose. The examiner who measures the variables is blind to the type of treatment performed for the patient (expansion with tooth-born or bone-born appliances).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204244303N2
Registration date:2012-04-28, 1391/02/09
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-04-28, 1391/02/09
Registrant information
Name
Mohammad Zandi
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1823 4047
Email address
zandi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2012-06-01, 1391/03/12
Expected recruitment end date
2014-06-01, 1393/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of dental & skeletal changes following surgically assisted maxillary
expansion with or without pterygomaxillary disjunction, and their long-term stability
Public title
Evaluation of dental & skeletal changes following surgically assisted maxillary
expansion with or without pterygomaxillary disjunction, and their long-term stability
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with narrow maxilla who are referred by orthodontists for palatal expansion Exclusion criteria: previous surgery on maxilla, previous orthodontic treatment on maxilla, presence of cleft lip and/or palate anomalies, Syndromic patients, taking any drug for a long time
Age
From 15 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not 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 Committeeو Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh street
City
Hamedan
Postal code
65178/518
Approval date
2012-04-16, 1391/01/28
Ethics committee reference number
230/9/35/16 /پ/د
Health conditions studied
1
Description of health condition studied
Narrow palate
ICD-10 code
K07.8
ICD-10 code description
Other dentofacial anomalies
Primary outcomes
1
Description
maxillary width after treatment
Timepoint
4 months and 12 months after surgery
Method of measurement
Examination of occlusion and casts
Secondary outcomes
1
Description
Thickness of bone overlaying roots of posterior maxillary teeth after treatment
Timepoint
4 months and 12 months after surgery
Method of measurement
CBCT analysis
2
Description
Width of floor of the nose after treatmemt
Timepoint
4 months and 12 months after surgery
Method of measurement
CBCT analysis
3
Description
Tipping of maxillary posterior teeth after treatment
Timepoint
4 months and 12 months after surgery
Method of measurement
CBCT analysis
Intervention groups
1
Description
]Intervention: Surgically assisted maxillary expansion without pterygomaxillary disjunction and activation of tooth-born expanders 0.5 mm a day until correction of maxillary narrowness
Category
Treatment - Surgery
2
Description
]Intervention: Surgically assisted maxillary expansion with pterygomaxillary disjunction and activation of tooth-born expanders 0.5 mm a day until correction of maxillary narrowness
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Zandi
Street address
Department of oral and maxillofacial surgery, Faculty of Dentistry, Shahid Fahmideh street
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Tavilani, Vice- Chancellor of university in research affairs
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh street
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Faculty of Dentistry, Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Zandi
Position
Associate Professor of Oral and Maxillofacial surgery
Other areas of specialty/work
Street address
Faculty of Dentistry, Shahid Fahmideh street
City
Hamedan
Postal code
65178-38677
Phone
+98 81 1823 4047
Fax
+98 81 1823 4014
Email
zandi88m@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Dentistry, Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Zandi
Position
Associate Professor of Oral and Maxillofacial surgery
Other areas of specialty/work
Street address
Faculty of Dentistry, Shahid Fahmideh street
City
Hamedan
Postal code
65178-38677
Phone
+98 81 1823 4047
Fax
+98 81 1823 4014
Email
zandi88m@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Dentistry, Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Zandi
Position
Associate Professor
Other areas of specialty/work
Street address
Faculty of Dentistry, Shahid Fahmideh street
City
Hamedan
Postal code
65178-38677
Phone
+98 81 1823 4047
Fax
+98 81 1823 4014
Email
zandi88m@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)