Effects of combined low-level laser and piezocision versus each technique separately on canine retraction
Design
Clinical trial with control group, with parallel groups, without blinding, randomized by block randomization method on 33 patients in 3 groups of 11 each
Settings and conduct
33patients from Ahvaz Dental School
In 3groups: A, one side the control one side the piezocision group (once). 1-2 points in the IR area of teeth 3 and 5 ,3 mm deep into the bone using a pizotome.
group B, one side control one side diode laser group. 810 nm laser with energy 8 J and power of 0/5W performed for 16 seconds at 6 points on the buccal and lingual side of the maxilla canine on day 1 and weeks 3 and 6. In group C, one The control side the other side consider the combination of piezocision + laser radiation with the same protocol as before.
After the alignment the first premolars are extracted, anchorage is maintained with a vertical stop in front of the 6 teeth, canine retraction on 17x25 ss and 150 g forces are done with a short size chain.
Each session (week 3.6.9) is molded, casts are scanned, and distance between the end of the midpoint of the third rug in the palate for each side (as a fixed point) to the midpoint of the canine tooth on each side is determined to determine the extent of retraction changes. The distance from that point to the central fossa of the tooth is measured to anchorage loss.
Participants/Inclusion and exclusion criteria
Admission: Age 15 to 25, Absence of any disease and requires extraction of first premolars on both sides; No entry: Previous orthodontics and trauma while extraction
Intervention groups
Diode laser radiation group, Piezocision group and the group combines two methods
In each group one side of maxilla will be consider as the control group and one side the action group.
Main outcome variables
Canine retraction rate in two maxillary quadrants
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201110049346N1
Registration date:2021-01-06, 1399/10/17
Registration timing:registered_while_recruiting
Last update:2021-01-06, 1399/10/17
Update count:0
Registration date
2021-01-06, 1399/10/17
Registrant information
Name
Rayan Chaharmahali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3447 1049
Email address
charmahali.r@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of combined low-level laser and piezocision versus each technique separately on canine retraction
Public title
Effects of combined low-level laser and piezocision versus each technique separately on canine retraction
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 15 to 25 years
Absence of any systemic disease and active periodontal disease
Need to extraction of the first premolars on both sides
NO Previous orthodontic treatment
It has the normal shape and structure of the canine, the second premolar and the first maxillary molar
Exclusion criteria:
Age
From 15 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
33
More than 1 sample in each individual
Number of samples in each individual:
2
n each of the 11 participants in one of the 3 study groups, one maxilla quadrant is considered as the action group (intervention) and the other quadrant is considered as the control group.
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random sequencing is done by restricted randomization method and since the equality of the two intervention groups is very important, the permuted block randomization subgroup is used.
Random allocation is concealed using opaque envelopes sealed in random sequence.
In this way, based on the sample size of the research, a number of non-transparent envelopes are prepared and each random sequence is recorded on a card and the cards are placed in the envelopes in order. In order to maintain a random sequence, envelopes are numbered in the same way on the outer surface. At the beginning of the registration of participants, based on the order of entry of eligible participants to study, one of the envelopes is opened in order and its assigned group is identified.
Finally, due to the split mouth of the study method, each quadrant of the patient's maxilla is assigned to the control group or the intervention is done by coin flipping (heads or tails).
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
Ethics Committee of Ahwaz Jundishapur University of Medical Sciences
Street address
Golestan. Khordad St., between Esfand St. and Iqbal St., Avisa Complex, Unit 5
City
Ahwaz
Province
Khouzestan
Postal code
6451766555
Approval date
2020-10-19, 1399/07/28
Ethics committee reference number
IR.AJUMS.REC.1399.612
Health conditions studied
1
Description of health condition studied
Orthodontic patient with treatment plan for extraction of 4 maxillary teeth
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Canine retraction rate in two maxillary quadrants using orthodontic piezo, laser and laser + piezo
Timepoint
In the samples of piezocision operation, measurements are made at the beginning of the study (before the intervention), 3, 6 and 9 weeks after the intervention on both control and operation sides (the piezocision operation is performed only once.) In the sample Laser measurements are performed at the beginning of the study, at weeks 3, 6 and 9. (The laser is irradiated on the first day and weeks 3 and 6.) In the combination group, 2 measurement methods are similar to the previous two methods at the beginning, week 3, 6 and 9 are performed. (In this group, the piezocision operation is performed once on the first day and the laser is irradiated on the first day and weeks 3 and 6).
Method of measurement
Scan of casts at 3, 6 and 9 weeks and measuring the amount of movement compared to the initial time
Secondary outcomes
empty
Intervention groups
1
Description
The group prepared by piezocision surgery. 11 subjects were randomly selected and in each individual, a maxilla quadrant was randomly selected one week after extraction of the first maxillary premolars and 1-2 points in the area. Between the roots of teeth 3 and 5 are determined based on the amount of keratinized gums and inserted to a depth of 3 mm into the bone using a piezoelectric device (Acteon, CUBE, France) and piezocision surgery will be performed. The operation is performed only once.The type of movement considered is the movement of the canine tooth alone, so the connection of teeth 5 and 6 and the upper incisors will be done together and a vertical stop will be placed in front of tooth 6 to maintain anchorage. Standard canine retraction is performed on 17x25 stainless steel wires by applying standard forces of 150 g using force gauge (COREX, HAAG-STREIT, Switzerland) using elastomeric China (American Orthodontics, Sheboygan, WI, USA) short size.On the first day and weeks 3, 6 and 9, molding will be done to measure the amount of retraction.
Category
Diagnosis
2
Description
Control group: The group prepared by the piezogen. Another quadrant of the maxilla is considered as the control group, and the wire and crease are placed in the same way to finally measure and compare the amount of retraction in millimeters on both sides.
Category
Diagnosis
3
Description
Intervention group: Laser irradiation group. 11 subjects were randomly selected and each maxillary quadrant was randomly selected one week after extraction of the first maxillary premolars. 810 nm laser radiation (dentaLase, QuickLase, Great Britain). ) With energy of 8 joules and power of 5 /. Watt will be performed for 16 seconds at 6 points on the buccal side and 6 points on the lingual side (two points on the cervical, two points on the middle region and two points on the apex) of the maxilla canine on the first day and weeks 3 and 6. The previous method is inserted and the molding is similar to the previous method.
Category
Diagnosis
4
Description
control group: Laser radiation group.Another quadrant of the maxilla is considered as the control group, and the wire and crease are placed in the same way to finally measure and compare the amount of retraction in millimeters on both sides.
Category
Diagnosis
5
Description
Intervention group: Combination group of laser radiation and piezocision operation.11 subjects were randomly selected and a maxillary quadrant in each individual was randomly selected one week after extraction of the first maxillary premolars.The piezocision operation and the first laser session are applied simultaneously on the selected side And wire and crease will be placed and molding will be done similar to the previous two methods.
Category
Diagnosis
6
Description
Control group: Laser irradiation and piezocision operation group.Another quadrant of the maxilla is considered as the control group, and the wire and crease are placed in the same way to finally measure and compare the amount of retraction in millimeters on both sides.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahwaz Dental School
Full name of responsible person
rayan chaharmahali
Street address
Golestn.dey avenue
City
Ahwaz
Province
Khouzestan
Postal code
6451766555
Phone
+98 61 3447 1049
Email
charmahali.r@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Morteza Gooran
Street address
Golestan.esfand avenue
City
Ahwaz
Province
Khouzestan
Postal code
6451766555
Phone
+98 61 3447 1049
Email
charmahali.r@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Rayan Chaharmahali
Position
رزیدنت ارتودنسی
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Golestan.Dey avenue
City
Ahwaz
Province
Khouzestan
Postal code
6451766555
Phone
+98 61 3447 1049
Email
charmahali.r@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Rayan Chaharmahli
Position
Orthodontics resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Golestan,dey avenue
City
Ahwaz
Province
Khouzestan
Postal code
6451766555
Phone
+98 61 3447 1049
Email
charmahali.r@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Rayan Chaharmahali
Position
Orthodontics resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Golestan,dey avenue
City
Ahwaz
Province
Khouzestan
Postal code
6451766555
Phone
+98 61 3447 1049
Email
charmahali.r@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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