Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000955718p
Ethics application status
Submitted, not yet approved
Date submitted
26/05/2022
Date registered
6/07/2022
Date last updated
6/07/2022
Date data sharing statement initially provided
6/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Three-dimensional assessment of the synergistic effects of Micro-osteoperforation combined with platelet-rich fibrin local injection on the rate of orthodontic tooth movement during canine retraction: a split-mouth randomized controlled clinical trial
Scientific title
Three-dimensional assessment of the synergistic effects of Micro-osteoperforation combined with platelet-rich fibrin local injection on the rate of orthodontic tooth movement during canine retraction: a split-mouth randomized controlled clinical trial
Secondary ID [1] 307224 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acceleration of orthodontic tooth movement 326469 0
Condition category
Condition code
Oral and Gastrointestinal 323742 323742 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will be explained to every subject in detail and an informed consent will be
obtained by the patient or parents, also obtained an individualized attendance records with an outcomes assessment sheet for all participants formalized for study monitoring.
According to the random allocation process, study groups will be categorized according
to the intervention procedures into 2 groups:
A: micro-osteoperforations only (MOPs) / Control group
B: micro-osteoperforations (MOPs) with injectable rich plasma fibrine i-RPF/
interventional group
A randomly selected side of maxillary arch will receive PRF combined with MOPs. The contralateral side will receive only MOPs and served as the control.
The application of micro-osteoperforations (MOPs) for both sides will be done by the primary investigator following a systematic protocol at UST clinics .
The MOPs will be placed at 5, 10 and 15 mm from the gingival margin and
performed under local anesthesia using a mini-screw (1.8 mm diameter, 8 mm length)
through a self-drilling method placed distal and mesial to the canine tooth.
The procedures anticipated to take 20-30 minutes.

canine retraction with absolute anchorage using mini-screws or temporary anchorage devices (TADs) will be initiated in both sides utilizing a NiTi closed coil spring with 150g force. The TADs placed between roots of 2nd premolar and 1st molar.
the protocol of platelet-rich fibrin local injection, including :
the inject-able plasma rich fibrin (i-PRF) will be obtained from 20 ml of blood drawn from each
patient’s brachial vein, centrifuged at 700 rpm for 3 min and then the separated plasma in an sterile needle will be immediately injected.
the injection of 5 ml of plasma rich fibrin (PRF) will be performed under local anesthesia into the mucous membrane of the buccal and palatal aspects of oral mucosa at the extraction sites for the intervention side at three level distance along the 1st premolar socket.
creation and injection of platelet-rich fibrin anticipated to take 30 - 40 minutes.

The procedures ( MOPs and platelet-rich fibrin injection) will be repeated 4 weeks later.
means it's done a twice only in the study duration.
Intervention code [1] 323819 0
Treatment: Surgery
Comparator / control treatment
the comparator / control group will be

group A : maxillary side that involving the application of micro-osteoperforations only (MOPs)

Control group
Active

Outcomes
Primary outcome [1] 331486 0
Rate of canine retraction will be evaluated before and after retraction in 6 time points
(T1 through T6) For the two groups of along 24 weeks using a digital caliper intra-orally and on the cast to measure the distance of canine movement in mm/4week or month.
the three dimensional evaluation of retraction will be done by CBCT that done twice only (T0) before canine retraction and after 6 months (Tf) or after complete canine retraction and utilizing a fix reference planes.
Timepoint [1] 331486 0
Rate of canine retraction will be evaluated before and after retraction in 6 time points
(T1 through T6) For the two groups of every 4 weeks for 24 weeks after starting the study by using a digital caliper intra-orally and on the cast to measure the distance of canine movement in mm/4week or month.
the three dimensional evaluation of retraction will be done using CBCT that done twice only (T0) before canine retraction and after 6 months (Tf) or after complete canine retraction and utilizing a fixed reference planes.
Secondary outcome [1] 410066 0
The secondary outcomes including the evaluation of canine external apical root resorption (EARR) using CBCT following canine retraction only in 2 time points :
Timepoint [1] 410066 0
The secondary outcomes will be evaluated before and after retraction in 2 time points
(T0 and Tf) For the two groups of along 24 weeks.
before canine retraction and after 6months or complete canine retraction
Secondary outcome [2] 410968 0
The secondary outcomes including the evaluation of alveolar bone dehiscence or fenestration using CBCT following canine retraction only in 2 time points :
Timepoint [2] 410968 0
2 time points only T0 and Tf
before canine retraction and after 6 months or complete canine retraction

Eligibility
Key inclusion criteria
- Age: 19- 38 years.
- Gender: females
- Participants requiring fixed orthodontic appliances in upper and lower archs.
- Treatment protocol: bilateral extraction of maxillary first premolars
- Medically: free of any medical disorders (diagnosed through proper, careful and detailed medical history that will be included in patient file).
Minimum age
19 Years
Maximum age
38 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- No Chronic medication: antibiotic or anti-inflammatory.
- No Systemic diseases: diabetes mellitus, kidney diseases and respiratory infection.
- No Mouth breathing, xerostomia, hyposalivation
- No Previous orthodontic treatment.
- No History of unusual oral habits like tongue thrusting, finger sucking etc.

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)
Sixty enclosed envelopes for both groups will be prepared before the study by orthodontist assistant. Each envelope containing the treatment allocation number which represent either the control or the intervention group for the left or right canine.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A software randomization program (Research Randomizer) will be used to generate random allocation tables that include random number sequences for the participants.
Two randomly sequencing numbered tables from 1 to 60 will be generate by the software. Each table represents a group of intervention for canine acceleration.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
a split mouth study design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The Shapiro-Wilk test will be applied to verify the normality of distribution of the examined variable on the whole sample.
The Chi2-test will be used to establish whether a significant difference existed between the numbers of patients in each group. Deviations from baseline will be tested for significance with the Wilcoxon signed ranks test (one-tailed).
The t- test for independent samples will be applied for the comparison between two groups, while the comparison between T0 to T6 will carried out with the t-test for paired sample and repeated measure ANOVA.
The level of significance set at 0.05. Statistical analyses performed using the statistical software SPSS for Windows (version 25.0, SPSS Inc., Chicago,IL,USA).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/03/2023
Actual
Date of last participant enrolment
Anticipated
31/03/2023
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 24802 0
Yemen
State/province [1] 24802 0
Sana'a

Funding & Sponsors
Funding source category [1] 311522 0
University
Name [1] 311522 0
University of Science & Technology
Country [1] 311522 0
Yemen
Primary sponsor type
University
Name
University of Science & Technology
Address
60 street
sana'a
yemen
Country
Yemen
Secondary sponsor category [1] 312936 0
None
Name [1] 312936 0
Address [1] 312936 0
Country [1] 312936 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310981 0
University Of Science and Technology ethical committe
Ethics committee address [1] 310981 0
Ethics committee country [1] 310981 0
Yemen
Date submitted for ethics approval [1] 310981 0
20/03/2022
Approval date [1] 310981 0
Ethics approval number [1] 310981 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119578 0
Dr Hend Abdulkarem Al-Haifi
Address 119578 0
Hend Adulkaream Adullah Al- Haifi
Assistant lecturer of Orthodontics , University of Science and Technology
60 street
Sana'a city
Yemen
Country 119578 0
Yemen
Phone 119578 0
+9671770878955
Fax 119578 0
Email 119578 0
[email protected]
Contact person for public queries
Name 119579 0
Hend Abdulkarem Al-Haifi
Address 119579 0
Hend Adulkaream Adullah Al- Haifi
Assistant lecturer of Orthodontics , University of Science and Technology
60 street
Sana'a city
Yemen
Country 119579 0
Yemen
Phone 119579 0
+9671770878955
Fax 119579 0
Email 119579 0
[email protected]
Contact person for scientific queries
Name 119580 0
Hend Abdulkarem Al-Haifi
Address 119580 0
Hend Adulkaream Adullah Al- Haifi
Assistant lecturer of Orthodontics , University of Science and Technology
60 street
Sana'a city
Yemen
Country 119580 0
Yemen
Phone 119580 0
+9671770878955
Fax 119580 0
Email 119580 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16203Study protocol  [email protected] 384130-(Uploaded-26-05-2022-00-59-18)-Study-related document.pdf



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.