Upper lip length changes after V-Y plasty and Lefort 1 osteotomy with and without maxillary impaction after 6 months.
Is there any mathematical relationship between impaction and upper lip length changes?
Design
A non-randomized controlled trial study with a control group, with factorial groups, which is composed of two groups of 17 patients.
Settings and conduct
Class III skeletal patients with maxillary deficiency referring to Farhikhtegan Hospital and affiliated private centers who meet the inclusion criteria are divided into two groups of 17 people depending on the presence or absence of maxillary vertical excess. Standard medical photography (1:1 ratio) of the frontal and profile view in NHP one week before and 6 months after surgery are taken. A single examiner measures upper lip length (subnasal- stomion) in Adobe Photoshop 2024.v25.7 and fill the sheets.
Participants/Inclusion and exclusion criteria
Patients with Class 3 skeletal deformity after completion of presurgical orthodontic treatment and with normal temporomandibular joints are included in the study.
Patients with asymmetric face, previous history of trauma or orthognathic surgery and with syndromic or non-syndromic cleft are excluded.
Intervention groups
Surgical steps of the two groups and the surgeon are the same, only in the intervention group, maxillary impaction is performed simultaneously to correct maxillary vertical excess.
Main outcome variables
Post operation upper lip length changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240521061855N1
Registration date:2024-05-24, 1403/03/04
Registration timing:registered_while_recruiting
Last update:2024-05-24, 1403/03/04
Update count:0
Registration date
2024-05-24, 1403/03/04
Registrant information
Name
Maryam Mostafavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2228 9789
Email address
maryami.mostafavi74@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-11-20, 1403/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of LeFort I maxillary impaction surgery effects on the upper lip length in skeletal class III patients
Public title
Le Fort I maxillary impaction in upper lip length
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient age between 18-30 year old
Patient with normal and asymptomatic Tempromandibular joint
Patients with dentofacial skeletal Cl III deformity whom need orthognathic surgery
Presurgical orthodontic phase completed
Patient with frontal and profile photography of face in NHP
Exclusion criteria:
Patients with syndromic and nonsyndromic clefts
Asymmetric face
History of previous orthognathic surgery
History of previous trauma
Patient who do not come for follow up after 6 months
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
All surgical procedures are the same in both groups except maxillary impaction surgery due to vertical maxillary excess in intervention group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Tehran
Street address
No. 2, Servati Ave., Shahid Lavasani Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1954915483
Approval date
2024-05-18, 1403/02/29
Ethics committee reference number
IR.IAU.DENTAL.REC.1403.051
Health conditions studied
1
Description of health condition studied
Anteroposterior maxillary deficiency with or without vartical excess
ICD-10 code
K07.1
ICD-10 code description
Anomalies of jaw-cranial base relationship
Primary outcomes
1
Description
Upper lip length changes six months post-surgical
Timepoint
one week prior to surgery and 6 months later
Method of measurement
ruler tool of Adobe Photoshop 2024.v25.7
Secondary outcomes
1
Description
Changes in upper lip length classification after surgery
Timepoint
one week prior and 6 months after surgery
Method of measurement
Measurement from before and after photographs of the patient and classification according to the normal range of 20-22 mm lip length
Intervention groups
1
Description
Intervention group: Patients with anteroposterior maxillary deficiency and vertical maxillary growth undergone maxillary advancement surgery and impaction. In impaction surgery, depending on the patient's problem, some of the maxilla bone is removed in general and the maxilla is raised.All surgical procedures are performed by single oral, maxillofacial surgeon,
Category
Treatment - Surgery
2
Description
Control group: Patients with anterior-posterior deficiency of maxilla undergo maxillary advancement surgery. All surgical procedures are performed by single oral, maxillofacial surgeon.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Farhikhtegan hospital
Full name of responsible person
Maryam Mostafavi
Street address
No. 2, Servati Ave., Shahid Lavasani Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1954915483
Phone
+98 21 2228 9789
Email
maryami.mostafavi74@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Azizi
Street address
No. 2, Servati Ave., Shahid Lavasani Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1954915483
Phone
+98 21 2228 9789
Email
maryami.mostafavi74@ yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Mostafavi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 2, Servati Ave., Shahid Lavasani Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1954915483
Phone
+98 21 2228 9789
Email
maryami.mostafavi74@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Mostafavi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 2, Servati Ave., Shahid Lavasani Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1954915483
Phone
+98 21 2228 9789
Fax
Email
maryami.mostafavi74@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Mostafavi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 2, Servati Ave., Shahid Lavasani Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1954915483
Phone
+98 21 2228 9789
Fax
Email
maryami.mostafavi74@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
After de-identifying participants, data on the primary outcome plus age, gender will be reported.
When the data will become available and for how long
Access starts 6 months after the publication of the results
To whom data/document is available
The data is open to the public.
Under which criteria data/document could be used
Access will be allowed if the data is needed to conduct further studies in this field or conduct systematic review studies.
From where data/document is obtainable
Maryam Mostafavi contact with e-mail:
maryami.mostafavi74@yahoo.com
What processes are involved for a request to access data/document
At first, send an e-mail to submit the request along with its reason, and then within a week, if there are no questions and the need for further investigation, the information will be sent.