comparing a mount of relapse after mandibular advancement surgery with elastic therapy and mandibular advancement surgery with inetermaxillary fixation
Design
this is a randomized clinical trial.two groups of skeletal class II patient would participate in the study. both groups would require 5 -10 mm mandibular advancement surgery. all patients would have operated with same surgical technique by same surgeon. After the surgery; one group of patients would have inter maxillary fixation for 4-6 weeks mean while the other group would have elastic therapy. The sample size would be 28 patients in each group.
Settings and conduct
patients would be operated in Talaghani hospital.
All patients undergo BSSO surgery with Dal pont's technique. After surgery, the first group will undergo elastic therapy and the other group will have IMF .this study could not be blinded because patients would realized post operative treatment modality (elastic therapy vs Inetrmaxillary fixation)
Participants/Inclusion and exclusion criteria
inclusion criteria:
1.patients with postpubertal skeletal maturity
2.patients with completed presurgical orthodontic treatment
3.patients with skeletal class II requiring mandibular advancement surgery.
exclusion criteria:
1. patients who require synchronized maxillary orthognatic surgery
2. patients with poorly controlled systematic disease such as diabetes melitus, etc.
Intervention groups
in this study no control group would be utilized;.
two groups of skeletal class II patient would participate in the study. both groups would require 5 -10 mm mandibular advancement orthognathic surgery. All patients would have operated with same surgical technique by same surgeon. After the surgery; one group of patients would have inter maxillary fixation for 4-6 weeks mean while the other group would have elastic therapy.
Main outcome variables
comparison of cephalometric points
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191126045510N1
Registration date:2020-01-26, 1398/11/06
Registration timing:prospective
Last update:2020-01-26, 1398/11/06
Update count:0
Registration date
2020-01-26, 1398/11/06
Registrant information
Name
Arash Sarafzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2303 1316
Email address
a.sarafzadeh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-19, 1398/11/30
Expected recruitment end date
2020-12-29, 1399/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of intermaxillary fixation’s impact on skeletal relapse after mandibular advancement surgery:A randomized clinical trial
Public title
Evaluation of inter maxillary fixation’s impact on skeletal relapse after mandibular advancement surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with skeletal class II requiring mandibular advancement surgery (5 -10 mm advancement)
patients with completed presurgical orthodontic treatment
patients with postpubertal skeletal maturity
Exclusion criteria:
patients who had synchronized maxillary orthognatic surgery
patients with poorly controlled systematic disease such as diabetes melitus, etc.
patients with previous anti resorptive drug such bisposphonates, etc.
Age
From 17 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
We select patients who have undergone preoperative orthodontics and they require 5-10 mm advancment mandibular orthodontic surgery. All samples are coded and arranged. After coding the samples we use a random number table to divide all samples in two groups. by moving in a row in table only the numbers smaller than the total number of samples are selected. Each samples with the same numbers is selected and is placed in the first group. we would continue this process until the half of samples is allocated in the first group. all other samples is assigned to the second group. The first group was selected as code one and the second group as number two. finally an other random number is selected in the table. if the number is odd the first group would be treated with intermaxillary fixation and if the number is even the second group would be treated as such. The non selected group would be treated with elastic therapy respectively.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran National committee for ethics in biomedical research
subjects in this study were patients with mandibular hypoplasia.
ICD-10 code
M26.04
ICD-10 code description
Mandibular hypoplasia
Primary outcomes
1
Description
Me- y axis: It is the distance between Menthon and Y-Axis on cephalogram.
Timepoint
It is evaluated in three time periods: before intervention (T0), one week after intervention (T1) and one year after intervention (T2).
Method of measurement
it would be evaluated by standard metallic ruler based on distance between cephalometric reference points on lateral cephalograms.
2
Description
B-Y axis: It is the distance between B point and Y-Axis on cephalogram
Timepoint
It is evaluated in three time periods: before intervention (T0), one week after intervention (T1) and one year after intervention (T2).
Method of measurement
it would be evaluated by standard metallic ruler based on distance between cephalometric reference points on lateral cephalograms.
3
Description
Pog -Y axis: It is the distance between Pog and Y-Axis on cephalom
Timepoint
It is evaluated in three time periods: before intervention (T0), one week after intervention (T1) and one year after intervention (T2).
Method of measurement
it would be evaluated by standard metallic ruler based on distance between cephalometric reference points on lateral cephalograms.
4
Description
Me- X axis: It is the distance between Menthon and X-Axis on cephalogram.
Timepoint
It is evaluated in three time periods: before intervention (T0), one week after intervention (T1) and one year after intervention (T2).
Method of measurement
it would be evaluated by standard metallic ruler based on distance between cephalometric reference points on lateral cephalograms.
5
Description
B-X axis: It is the distance between B point and X-Axis on cephalogram
Timepoint
It is evaluated in three time periods: before intervention (T0), one week after intervention (T1) and one year after intervention (T2).
Method of measurement
it would be evaluated by standard metallic ruler based on distance between cephalometric reference points on lateral cephalograms.
6
Description
Pog -X axis: It is the distance between Pog and X-Axis on cephalogram
Timepoint
It is evaluated in three time periods: before intervention (T0), one week after intervention (T1) and one year after intervention (T2).
Method of measurement
it would be evaluated by standard metallic ruler based on distance between cephalometric reference points on lateral cephalograms.
Secondary outcomes
empty
Intervention groups
1
Description
control group: skeletal class II patents with 5 -10 mm skeletal discrepancy undergo mandibular advancement orthognathic surgery with bilateral sagittal split osteotomy with Dalpont's technique. after ward they would receive elastic therapy with medium force class II (4.5 Oz). in each side of patients mouth medium force elastic would be inserted from mandiular premolars to maxillary canins and from mandibular first molars to maxillary second premolars.
Category
Treatment - Other
2
Description
Intervention group: Intervention group: skeletal class II patents with 5 -10 mm skeletal discrepancy undergo mandibular advancement orthognathic surgery with bilateral sagittal split osteotomy with Dalpont's technique. after ward they would receive inter maxillary fixation for 6 weeks with 28 guages wire brackets.