Evaluating the Efficacy of Micro-Osteoperforations Technique on the Orthodontic Tooth Movement Acceleration in Moderate Mandibular Anterior Crowding Cases Treated With Clear Aligners

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-26
SponsorHama University

About this trial

Patients with moderate mandibular anterior crowding will be treated in this study. The efficacy of micro-osteoperforations technique by special drill in accelerating orthodontic tooth movement during clear aligners therapy will be assessed along with patient's pain and satisfaction.

There are two groups:

1. a group of patients in which participants will be received treatment with the traditional clear aligners technique in addition to a micro-osteoperforations technique. 2. a group of patients in which participants will be received treatment with the traditional clear aligners technique alone

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Completion of permanent dentition (except third molars)

Moderate crowding (4-6 mm according to Little's index)

Absence of medications intake that interferes with pain perception for at least one week before the beginning of the treatment

Number of aligners ≥ 8 aligners.

Disqualifiers

• Systematic diseases that could affect bone and tooth movement and no contraindication avoid oral surgery

Medical conditions that affect tooth movement (Corticosteroid, NSAIDs)

Patients had previous orthodontic treatments

Poor oral hygiene or concurrent periodontal disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Micro-osteoperforations Technique

    Device

    Micro-Osteoperforations Technique (MOPs) Surgery will be performed to the lower anterior bony segment of the lower jaw in order to accelerate tooth movement.

  • Active comparater

    Device

    Active Comparator: Traditional treatment The patients in this group will be receive treatment with the traditional clear aligners technique without any surgical procedure.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Micro-osteoperforationsExperimental treatment 1 intervention
Group B: Clear alignerExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Little's Index of Irregularity

The irregularity of the lower incisors is calculated by measuring the amount of deviations of the anatomic contact points between the six anterior teeth in the horizontal direction in mm, since the sum of these measurements represents the value of the index (Little, 1975). When the sum of these deviations is less than 3 mm, this indicates that the teeth are slightly crowded. When the sum is greater than 10 mm, this indicated very severe crowding. The ordinary orthodontic treatment aims to keep this Index less than 1 mm at the end of treatment.

Time frame
T0: immediately before the start of orthodontic treatment; T1: after one month; T2: after two months; T3: after 5 months when Little's Index of Irregularity less than 1 mm and final aligner does not apply any pressure
2

Overall treatment Time

the overall time required to complete the treatment was calculated by calculating the number of days between (To) and (T3).

Time frame
After 5 months when Little's Index of Irregularity less than 1 mm and final aligner will be properly fitting and does not apply any pressure on the teeth with absolute ease of placing and removing it from the teeth,

Secondary outcomes

1

Change in the levels of pain

Pain is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of pain being experienced. The left end of the line refers to no pain (VAS=0) where the right end refers to maximum (unimaginable) pain (VAS=100). The level of pain is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the pain.

Time frame
4 ,12,24,48 hours following the onset of orthodontic treatment
2

Satisfaction using VAS

satisfaction is assessed for both groups by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of satisfaction. The left end of the line refers to no satisfaction (VAS=0) where the right end refers to maximum satisfaction (VAS=100). The level of satisfaction is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the satisfaction.

Time frame
After 5 months when Little's Index of Irregularity less than 1 mm and final aligner will be properly fitting and does not apply any pressure on the teeth with absolute ease of placing and removing it
3

Satisfaction with the ease of the procedure

is assessed for both groups by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of ease. The left end of the line refers to no ease (VAS=0) where the right end refers to maximum ease (VAS=100). The grade of ease is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the ease of the procedure.

Time frame
After 5 months when Little's Index of Irregularity less than 1 mm and final aligner will be properly fitting and does not apply any pressure on the teeth with absolute ease of placing and removing it from the teeth,
4

Satisfaction through acceptability of the procedure

Patients in micro-Osteoperforations group were asked about possibility of repeating the procedure, and they answered using a two-point scale (1. Yes or 2. No).

Time frame
After 5 months when Little's Index of Irregularity less than 1 mm and final aligner will be properly fitting and does not apply any pressure on the teeth with absolute ease of placing and removing it from the teeth,]

Other outcomes

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