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Completed

NCT Number: NCT02975765

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

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.

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Key information

Age range

16 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Departments of Orthodontics and Oral and Maxillofcial Surgery, University of Damascus Dental School

Damascus, DM20AM18, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Piezosurgery

Procedure

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

Other names: Piezocision

Primary outcomes

  1. Levels of Pain and Discomfort at one day

    Time frame: at 24 hours following the engagement of first initial arch wire in the brackets

    Pain and discomfort will be measured on visual analog scale

  2. Levels of Pain and Discomfort at seven days

    Time frame: at seven days following the onset of orthodontic treatment

    Pain and discomfort will be measured on visual analog scale

  3. Levels of Pain and Discomfort at 14 days

    Time frame: at 14 days following the onset of orthodontic treatment

    Pain and discomfort will be measured on visual analog scale

  4. Levels of Pain and Discomfort at 28 days

    Time frame: at 28 days following the onset of orthodontic treatment

    Pain and discomfort will be measured on visual analog scale

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Nov 29, 2016
Registry last updated
Jul 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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