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Evaluation of the Levels of Pain and Discomfort Between Two Methods of Correcting Misaligned Teeth

Evaluation of the Levels of Pain and Discomfort Between Piezosurgery-assisted Corticotomy Versus Traditional Method of Aligning Crowded Lower Anterior Teeth: a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02975765
Enrollment
36
Registered
2016-11-29
Start date
2016-03-31
Completion date
2017-04-23
Last updated
2017-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malocclusion, Crowded Teeth, Surgical Incision

Keywords

corticotomy, minimally invasive, piezosurgery, piezocision, pain, discomfort

Brief summary

Applying flapless piezocision corticotomies on the alveolar bone and separating anterior mandibular teeth using a piezosurgery device (i.e. ultrasonic waves that perform very accurate incisions without any sutures following this procedure) may improve the speed of tooth alignment during orthodontic treatment. This study consists of two groups, patients will be randomly assigned to one of these two groups. The levels of pain and discomfort of this procedure on 18 patients (experimental group) will be evaluated,whereas the second group (control group) will receive a traditional orthodontic therapy.

Detailed description

According to the American Association of Orthodontists (AAO), the length of comprehensive orthodontic treatment ranges between 18-30 months, depending on treatment options and individual characteristics. In addition, orthodontic treatment time ranges between 25-35 months for extraction therapies, respectively. Reducing orthodontic treatment time is one of the main goals for orthodontists, due to problems such as root resorption, periodontal disease and caries that are associated with prolonged treatment time. Many techniques have been introduced to accelerate orthodontic tooth movement; surgical and non-surgical. The surgical approach is the most clinically applied and most tested with known predictions and stable results. Surgical approaches usually vary from total block osteotomies to flapless partial corticotomies .In spite of corticotomy-assisted orthodontic treatment efficiency, the invasiveness of these procedures (i.e. requiring full mucoperiosteal flaps elevation) might have limited their widespread acceptance among orthodontists and patients. Therefore, more conservative flapless corticotomy techniques have recently been proposed. These procedures can be accomplished in a reasonably short periods that might produce less pain and discomfort, so we will gain better patient acceptance. Although various techniques of flapless corticotomy have been reported to be successful in practice, scientific evidence on their acceptance and compatibility is little in the literature.

Interventions

PROCEDUREPiezosurgery

The surgical tip is going to be used to make small cuts into the cortex of the alveolar bone between the crowded teeth.

Sponsors

Damascus University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 26 Years
Healthy volunteers
No

Inclusion criteria

1. Adult healthy patients , Male and female, Age range: 16-26 years. 2. Severe crowding ≤ 7 (Little's irregularity index) 3. Permanent occlusion. 4. Exist all the Mandibular teeth (except third molars). 5. Good oral and periodontal health: * Probing depth\<4 mm * No radiographic evidence of bone loss . * Gingival index≤ 1 * Plaque index ≤ 1

Exclusion criteria

1. Medical problems that affect tooth movement (corticosteroid, NSAIDs, …) 2. Patients have anti indication for oral surgery ( medical - social - psycho) 3. Presence of primary teeth in the mandibular arch 4. Missing permanent mandibular teeth (except third molars). 5. Poor oral hygiene or Current periodontal disease: * Probing depth ≥ 4 mm * radiographic evidence of bone loss * Gingival index \> 1 * Plaque index \> 1 6. Patient had previous orthodontic treatment

Design outcomes

Primary

MeasureTime frameDescription
Levels of Pain and Discomfort at one dayat 24 hours following the engagement of first initial arch wire in the bracketsPain and discomfort will be measured on visual analog scale
Levels of Pain and Discomfort at seven daysat seven days following the onset of orthodontic treatmentPain and discomfort will be measured on visual analog scale
Levels of Pain and Discomfort at 14 daysat 14 days following the onset of orthodontic treatmentPain and discomfort will be measured on visual analog scale
Levels of Pain and Discomfort at 28 daysat 28 days following the onset of orthodontic treatmentPain and discomfort will be measured on visual analog scale

Countries

Syria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026