A clinical trial to compare the effectiveness of micro-implant based appliances with pendulum appliances for maxillary molar distalization in patients requiring orthodontic treatment
To compare the effectiveness of micro-implant based appliances with pendulum appliances for maxillary molar distalization in patients who need orthodontic treatment
Design
Thirty patients whose maxillary second molars had not grown and visited Dental Clinic of Mashhad Faculty of Dentistry were randomly selected and assigned to control and intervention groups. A code was allocated to each of the participants.
Settings and conduct
Patients whose second molar had not grown and visited the Dental Clinic of Mashhad Faculty of Dentistry, Mashhad, Iran, are chosen as the participants of the study. In this single-blind study, the participants are unaware of the type of treatment
Participants/Inclusion and exclusion criteria
Study population: Age higher than 12 years; dental Class II malocclusion and skeletal malocclusion class I or II; Lack of growth maxillary second molars.
Exclusion criteria: In maturity or later of CS3 stages; having certain systemic diseases.
Intervention groups
The control group undergoes treatment with pendulum appliance, a device balancing the maxillary molar teeth by using denture anchorage and palate with two active springs. The intervention group undergoes treatment with micro-implant based appliances in each side of the jaw, two mini-screws are placed in the mesial molar area
Main outcome variables
Evaluation and comparison of the difference in the maxillary first molar angular via measuring all axis dental, the amount of root recession tooth categorized into 3 Grades (G0: without resorption, G1: mild resorption, G2: moderate to severe resorption) by cephalometric radiography and the degree of pain as assessed by visual analogue scale before and 3 months after treatment in the intervention and control groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170128032230N2
Registration date:2018-08-08, 1397/05/17
Registration timing:prospective
Last update:2018-08-08, 1397/05/17
Update count:0
Registration date
2018-08-08, 1397/05/17
Registrant information
Name
Hossein Khaki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3625 9865
Email address
khakih941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-11, 1397/09/20
Expected recruitment end date
2020-07-31, 1399/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effectiveness of micro-implant based appliances with pendulum appliances for maxillary molar distalization in patients requiring orthodontic treatment
Public title
Maxillary molar distalization in patients who need orthodontic treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age higher than 12 years
Dental Class II malocclusion and skeletal malocclusion class I or II
Lack of growth maxillary second molars
Exclusion criteria:
Having certain systemic diseases
In maturity or later of CS3 stages
Age
From 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
A randomized, clinical trial based on random number table
Settings and conduct
Blinding (investigator's opinion)
Single blinded
Blinding description
This single-blind study, the responsible for data collection are unaware of are unaware of the type of treatment.
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
Province
Razavi Khorasan
Postal code
9195965919
Approval date
2016-06-29, 1395/04/09
Ethics committee reference number
IR.mums.sd.REC.1395.138
Health conditions studied
1
Description of health condition studied
orthodontic
ICD-10 code
Z47.8
ICD-10 code description
Other specified orthopaedic follow-up care
Primary outcomes
1
Description
the difference in the angle of the maxillary first molar
Timepoint
before and 3 months post-treatment
Method of measurement
cephalometric radiography
2
Description
the amount of root recession tooth
Timepoint
before and 3 months post-treatment
Method of measurement
cephalometric radiography
Secondary outcomes
1
Description
the degree of pain as assessed
Timepoint
before and 3 months post-treatment
Method of measurement
visual analogue scale
Intervention groups
1
Description
Control group: Treatment with pendulum appliance, a device that distalizes the maxillary molar teeth using dental and palatal anchorage with two active springs.
Category
Treatment - Devices
2
Description
Intervention group: Treatment with mini-screw based appliances. On each side of the jaw two mini-screws in the mesial-molar area (one mini screw between the roots of the 5-6 tooth, and the other between the roots of the 4-5 teeth on the buccal surface). Then, a special spring designed for the distalization of the molar via TMA wire was tailored for each patient and mounted on mini-screws.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Faculty of Dentistry Dental Clinic
Full name of responsible person
Hossein Khaki
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
Hoseinkhaki88@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
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
Province
Razavi Khorasan
Postal code
91375345
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
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
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Khaki
Position
Orthodontic Residents
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
Hoseinkhaki88@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Khaki
Position
Orthodontic Residents
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
Hoseinkhaki88@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Khaki
Position
Orthodontic Residents
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
Hoseinkhaki88@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The total data to be included are the primary and secondary effects to be shared.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Our data will only be available to researchers working in science center and university.
Under which criteria data/document could be used
Our data will be available for scholars working in science center and university.
From where data/document is obtainable
Hossein Khaki provides the analysis code to the applicants via email: Hoseinkhaki88@gmail.com
What processes are involved for a request to access data/document
Data collection was done for 10 months, data were collected one month, statistical analysis of one month, information dissemination as a article six months.