Trial Outcomes & Findings for Micro-osteoperforations and Tooth Movement (NCT NCT02473471)

Results Overview

The baseline 3D digital model was superimposed to 3D digital models of the 1st month to determine the anterioposterior displacement of canines.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

Baseline to 1st month

Results posted on

2017-11-28

Participant Flow

Participants recruited from a postgraduate clinic at Jordanian University of Science and Technology, in Irbid city, Jordan between Aug 2015 and Jan 2016.

Participant milestones

Participant milestones
Measure	All Study Participants Split-mouth design study in which the intervention (MOP Side) was randomly assigned to either right or the left side in the maxillary arch where other side serves as a control. Randomization was accomplished with block randomization with a permuted block size of 2 with 1:1 allocation ratio to either right or left with allocations concealed in opaque, sealed envelopes. Blinding was applicable at data collection and analysis stage.
Overall Study STARTED	35
Overall Study Received Allocated Intervention	33
Overall Study Randomized Not Treated	2
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	All Study Participants Split-mouth design study in which the intervention (MOP Side) was randomly assigned to either right or the left side in the maxillary arch where other side serves as a control. Randomization was accomplished with block randomization with a permuted block size of 2 with 1:1 allocation ratio to either right or left with allocations concealed in opaque, sealed envelopes. Blinding was applicable at data collection and analysis stage.
Overall Study poor oral hygiene	2
Overall Study Lost to Follow-up	1

Baseline Characteristics

Micro-osteoperforations and Tooth Movement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=35 Participants Includes groups randomized to receive MOP intervention on one side while the other side serve as control side.
Age, Continuous	19.26 years STANDARD_DEVIATION 2.48 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment Jordan	35 participants n=5 Participants
Sella-Nasion to A Point Angle (SNA)	81.9 Degree STANDARD_DEVIATION 4.07 • n=5 Participants
Sella-Nasion to B Point Angle (SNB)	76.5 Degree STANDARD_DEVIATION 3.85 • n=5 Participants
A point to B Point Angle (ANB)	5.5 Degree STANDARD_DEVIATION 2.69 • n=5 Participants
Maxillary mandibular plane angle	28.9 Degree STANDARD_DEVIATION 4.27 • n=5 Participants
Lower anterior facial height(LAFH)	55.67 mm STANDARD_DEVIATION 1.81 • n=5 Participants
Upper incisor inclination	119.94 Degree STANDARD_DEVIATION 7.53 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 1st month

Population: Thirty-five subjects were randomized to receive MOP to either right or left sides with 1:1 allocation ratio. Three impressions were missing at first month due to alginate distortion.

The baseline 3D digital model was superimposed to 3D digital models of the 1st month to determine the anterioposterior displacement of canines.

Outcome measures

Outcome measures
Measure	MOP Side n=29 Participants The Micro-osteoperforation side (The Intervention side)	Control Side n=29 Participants Non intervention side
3D Digital Model Measurements of Canine Rate of Tooth Movement	0.65 mm Standard Deviation 0.26	0.67 mm Standard Deviation 0.34

PRIMARY outcome

Timeframe: Baseline to 2nd month

Population: Thirty-five subjects were randomized to receive MOP to either right or left sides with 1:1 allocation ratio. only one impression was lost to be taken by a clinician at two months period.

The baseline 3D digital model was superimposed to 3D digital models of 2nd month to determine the anterioposterior displacement of canines.

Outcome measures

Outcome measures
Measure	MOP Side n=31 Participants The Micro-osteoperforation side (The Intervention side)	Control Side n=31 Participants Non intervention side
3D Digital Model Measurements of Canine Rate of Tooth Movement	1.36 mm Standard Deviation 0.49	1.28 mm Standard Deviation 0.50

PRIMARY outcome

Timeframe: Baseline to 3rd month

Population: Thirty-five subjects were randomized to receive MOP to either right or left sides with 1:1 allocation ratio. Three impressions were missing at first month due to alginate distortion, and only one impression was lost to be taken by a clinician at two months.

The baseline 3D digital model was superimposed to 3D digital models of 3rd month to determine the anterioposterior displacement of canines.

Outcome measures

Outcome measures
Measure	MOP Side n=32 Participants The Micro-osteoperforation side (The Intervention side)	Control Side n=32 Participants Non intervention side
3D Digital Model Measurements of Canine Rate of Tooth Movement	1.93 mm Standard Deviation 0.74	1.88 mm Standard Deviation 0.67

PRIMARY outcome

Timeframe: Baseline to 1st month

Population: 32 subjects were analyzed to receive MOP to either right or left sides. Only one patient was lost to follow up at the first month time point.

Direct intraoral measurement of the distance between canine and second premolar in the patient's mouth was done every week using a digital caliper, from the upper mesial wing of the canine bracket to upper distal wing of second premolar bracket in both right and left sides parallel to the occlusal plane for 3 months.

Outcome measures

Outcome measures
Measure	MOP Side n=31 Participants The Micro-osteoperforation side (The Intervention side)	Control Side n=31 Participants Non intervention side
Intra Oral Measurements of Canine Rate of Tooth Movement	1.23 mm Standard Deviation 0.45	1.17 mm Standard Deviation 0.42

PRIMARY outcome

Timeframe: Baseline to 2nd month

Population: 32 subjects were analyzed to receive MOP to either right or left sides.

Direct intraoral measurement of the distance between canine and second premolar in the patient's mouth was done every week using a digital caliper, from the upper mesial wing of the canine bracket to upper distal wing of second premolar bracket in both right and left sides parallel to the occlusal plane for 3 months.

Outcome measures

Outcome measures
Measure	MOP Side n=32 Participants The Micro-osteoperforation side (The Intervention side)	Control Side n=32 Participants Non intervention side
Intra Oral Measurements of Canine Rate of Tooth Movement	2.27 mm Standard Deviation 0.72	2.24 mm Standard Deviation 0.63

PRIMARY outcome

Timeframe: Baseline to 3 month

Population: 32 subjects were analyzed who received MOP to either right or left sides.

Direct intraoral measurement of the distance between canine and second premolar in the patient's mouth was done every week using a digital caliper, from the upper mesial wing of the canine bracket to upper distal wing of second premolar bracket in both right and left sides parallel to the occlusal plane for 3 months.

Outcome measures

Outcome measures
Measure	MOP Side n=32 Participants The Micro-osteoperforation side (The Intervention side)	Control Side n=32 Participants Non intervention side
Intra Oral Measurements of Canine Rate of Tooth Movement	3.18 mm Standard Deviation 1.03	3.26 mm Standard Deviation 0.81

SECONDARY outcome

Timeframe: Baseline to 3rd month

It will be evaluated by taking periapical radiograph for canines before canine retraction and after 3 months period