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Trial registered on ANZCTR


Registration number
ACTRN12622000310763
Ethics application status
Approved
Date submitted
18/03/2021
Date registered
18/02/2022
Date last updated
30/05/2024
Date data sharing statement initially provided
18/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of two types of treatment for adolescent patients with protrusion of lower jaw and constriction of upper jaw
Scientific title
Evaluation of the effectiveness of the Removable Mandibular Retractor with Slow Maxillary Expansion compared to the Bone-anchored Intermaxillary Traction with Rapid Maxillary Expansion in the Correction of Skeletal class III malocclusion associated with maxillary constriction in growing patients between 12 - 15 years.: A Randomized Controlled Trial
Secondary ID [1] 305851 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
a maxillary constriction
skeletal class III malocclusion
321169 0
Condition category
Condition code
Oral and Gastrointestinal 318969 318969 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For the BAIMT with RME group:
The duration of the procedure will be about 12 months included Sagittal and transverse correction stage and retention stage .
This procedure will be carried out initially by the orthodontist and later by The patient or one of his parents
The patient or one of his parents will activate the expander twice daily (0.4 mm) until an overcorrection of maxillary constriction about 2-3 mm will be obtained





(experimental group): bone-anchored intermaxillary traction (BAIMT) associated with rapid maxillary expansion(RME) group


Orthodontic procedures:
1. Active phase period:



The group: BAIMT with RME
The appliance consists of (1) bonded modified Hyrax palatal expander with occlusal splints bonded with GIC on the upper premolars/deciduous molars and upper first molars, (2) hooks (made of 0.9 mm stainless steel wire) for attaching elastic bands placed distal to the first molars . Two self-drilling mini-implants (1.6 mm diameter, 8 mm length) will be inserted under local anesthesia into the buccal alveolar bone between the mandibular canine and the first premolar roots on both sides with an insertion angle of about 45° to 60° with the alveolar process. A periapical radiograph will be taken beforehand to assure proper insertion without damaging the neighboring roots . Intermaxillary elastics will be applied between the hooks and the mandibular anterior mini-implants, generating a 100 g force on each side of the jaw; in the first week (5/16 inch) followed by 3/16 medium size to generate an orthodontic force of about 200 g on each side until the end of treatment. Patients will be asked to wear elastics for 16 hours per day and replace elastics daily or when they will get damaged . The patient or one of his parents will activate the expander twice daily (0.4 mm) until an overcorrection of maxillary constriction about 2-3 mm will be obtained .
The patients in the two groups will be seen within one week, following the appliance’s first insertion, two weeks following the first insertion, and then at monthly visits to observe the change in incisor relationship, monitor patient’s compliance by the researcher himself . Change in the incisor relationship from a negative overjet (i.e., + 1.5 mm or greater) will be considered the sign of successful treatment in the sagittal plane.
If the defect in the transverse plane will be corrected before the one in the sagittal plane, the expansion will be stopped while the patient will be asked to continue wearing the appliance until the defect in the sagittal plane will be corrected and vice versa.
The questionnaire will be distributed to the patients at five times by the researcher himself: (T1) after one day of the beginning of the treatment, (T2) after one week (T3) after four weeks, (T4) after three months, (T5) after six months. The questionnaire will be filled in by the patient at the five times.
Intervention code [1] 320042 0
Treatment: Devices
Comparator / control treatment
RMR with SME group (control group)

The first group: RMR with SME group
The appliance consists of (1) upper acrylic plate with posterior bilateral bite plate, (2) reverse labial arch 0.9 mm of stainless steel, (3) Adam’s clasps on the upper first permanent molars (0.7 mm stainless steel wire), (4) midline split incorporating one expansion screw, (5) anterior sagittal expansion screw will be used when there will be a need to correct the axes of the upper incisors. . Patients will be asked to wear the RMR for 16 hours per day, including bedtime. The appliance will be activated monthly to adjust the anteroposterior location of the reverse arch to maintain passive (With light pressure) contact with the cervical regions of the lower anterior teeth . The patient or one of his parents will activate the expander twice weekly until an overcorrection of maxillary constriction about 2-3 mm will be achieved.

The duration of the procedure will be about 12 months included Sagittal and transverse correction stage and retention stage .
This procedure will be carried out initially by the orthodontist and later by The patient or one of his parents
. The patient or one of his parents will activate the expander twice weekly until an overcorrection of maxillary constriction about 2-3 mm will be achieved.
The patient will be monitored monthly to ensure compliance.The questionnaire will be distributed to the patients at five times by the researcher himself: (T1) after one day of the beginning of the treatment, (T2) after one week (T3) after four weeks, (T4) after three months, (T5) after six months. The questionnaire will be filled in by the patient at the five times.
Control group
Active

Outcomes
Primary outcome [1] 326885 0



Antero posterior(sagittal) changes(lateral cephalogram)
Timepoint [1] 326885 0

Apanorama before the beginning of the treatment, lateral cephalogram, posterio-anterior cephalogram will be taken for all patients at two times: (T1) before the beginning of the treatment, (T2) at the end of the retention.
The total treatment period for the participant from the beginning of the x-ray procedure until the end of the retention phase on average 12 months.
Primary outcome [2] 329629 0
Arch width (transverse) changes( posterio-anterior cephalogram )
Timepoint [2] 329629 0
assessed at a single timepoint at 12 months post-commencement of intervention,
Secondary outcome [1] 399923 0
discomfort(the four-point scale: (1) None (2) mild (3) moderate (4) severe)
Timepoint [1] 399923 0
assessed monthly until 12 months post-commencement of intervention

Eligibility
Key inclusion criteria
Inclusion criteria
(1) Angle’s class III malocclusion
(2) Anterior crossbite on two teeth or more or an edge-to-edge bite with or without an anterior shift of the mandible during the closure
(3) Skeletal class III relationship judged clinically and confirmed radiographically (– 4 < ANB < + 1)
(4) Normal inclination of the lower incisors with an incisor mandibular plane angle (IMPA) not exceeding 100° and not less than 85°
(5) An indication for maxillary expansion (maxillary constriction)
(6) Growing patients between 12 and 15 years.
(7) Permanent dentition
(8) No craniofacial syndromes or cleft lip and/or palate abnormalities
(9) Absence of supernumerary teeth or missing teeth except for the third molars
(10) No previous orthodontic treatment.

(11) Malaysian patients.
Minimum age
12 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
• (1) Skeletal class III relationship caused predominantly by maxillary deficiency (SNA angle should have been less than 78 with a normal SNB angle)
• (2) Severe skeletal class III resulting primarily from mandibular prognathism (ANB less than – 4° with no functional shift on closure)
• (3) Patients with diseases that prevent the application of mini-implants (e.g., osteoporosis – treated with cortisone and its derivatives- treated with radiation)
• (4) A convergence between the roots of the canine and first premolar assessed radiographically
• (5) Facial asymmetry (more than 2 mm of deviation of the mandibular midline from the facial midline)
• (6) MM angle greater than 35° or SN-MP angle greater than 40°.
• (7) One of the parents is not Malaysian.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization and allocation concealment:
The allocation sequence will be concealed using sequentially numbered, opaque, sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence generation will be produced using a computer-generated random number system utilizing Minitab®16 software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis
Descriptive and inferential statistics will be performed using Minitab®16 (Minitab Inc., Pennsylvania, PA, USA). Anderson–Darling normality tests will be performed to check the distribution of data. Parametric (two-sample t) tests or nonparametric (Mann–Whitney U test) tests will be used as appropriate to detect significant differences between the two groups, with the level of significance set at 0.05. A Bonferroni correction of the significance level will be used to adjust for multiple testing (i.e., a result with a p-value less than 0.017 will be considered significant).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2023
Actual
1/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
42
Accrual to date
26
Final
Recruitment outside Australia
Country [1] 23546 0
Malaysia
State/province [1] 23546 0

Funding & Sponsors
Funding source category [1] 308134 0
University
Name [1] 308134 0
University Sains Malaysia
Country [1] 308134 0
Malaysia
Primary sponsor type
University
Name
Universiti Sains Malaysia
Address
Orthodontic Unit,
School of Dental Sciences,
Universiti Sains Malaysia, 16150,
Kota Bharu, Kelantan,
Malaysia.
Country
Malaysia
Secondary sponsor category [1] 308898 0
None
Name [1] 308898 0
Address [1] 308898 0
Country [1] 308898 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308121 0
. Human Research Ethics Committee of Universiti Sains Malaysia,
Ethics committee address [1] 308121 0

MOHD BAZLAN HAFIDZ MUKRIM
Science officer
Secretary
Research Ethics Committee (Human) - JEPeM USM
Universiti Sains Malaysia
Health Campus
16150 Kubang Kerian
Kelantan, Malaysia.
Ethics committee country [1] 308121 0
Malaysia
Date submitted for ethics approval [1] 308121 0
28/02/2021
Approval date [1] 308121 0
04/05/2021
Ethics approval number [1] 308121 0

Summary
Brief summary

Study of the anterior bone defect located in the upper and lower jaws and correct this defect using two devices and compare them in patients aged 12 to 15 years
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109610 0
Dr Ahmad Salim Zakaria
Address 109610 0

Orthodontic Unit,
School of Dental Sciences,
Universiti Sains Malaysia, 16150,
Kota Bharu, Kelantan,
Malaysia.
Country 109610 0
Saudi Arabia
Phone 109610 0
+966 551809729
Fax 109610 0
Email 109610 0
[email protected]
Contact person for public queries
Name 109611 0
Ahmad Salim Zakaria
Address 109611 0

Orthodontic Unit,
School of Dental Sciences,
Universiti Sains Malaysia, 16150,
Kota Bharu, Kelantan,
Malaysia.
Country 109611 0
Saudi Arabia
Phone 109611 0
+966 551809729
Fax 109611 0
Email 109611 0
[email protected]
Contact person for scientific queries
Name 109612 0
Ahmad Salim Zakaria
Address 109612 0

Orthodontic Unit,
School of Dental Sciences,
Universiti Sains Malaysia, 16150,
Kota Bharu, Kelantan,
Malaysia.
Country 109612 0
Saudi Arabia
Phone 109612 0
+966551809729
Fax 109612 0
Email 109612 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.