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OpenTrials
Completed

NCT Number: NCT02606331

Efficacy of Minimally Invasive Surgical Technique in Accelerating Orthodontic Treatment

Thirty six patients needs therapeutic extraction of the maxillary first premolars with subsequent retraction of the maxillary canines will be divided randomly into two groups : piezocision group and the ER:yttrium aluminum garnet (YAG) laser group. In each group, piezocision or hard laser-assisted flapless corticotomy will randomly assigned to one side of the maxillary arch at the first premolar region, and the other side served as the control. Canine retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side, soldered trans-palatal arch will be used as an anchor unit.

Pre- and post distalization dental casts will be evaluated to study rate of canine distalization, canine rotation and anchorage loss over a follow-up period until a Class I canine relationship is achieved. The levels of pain and discomfort will be self-reported using a questionnaire with visual analog scales administered at four assessment times during the first month after the minimally invasive procedure.

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Key information

Age range

14 year–27 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthodontics, University of Damascus Dental School

Damascus, Rif-dimashq Governorate, DM20AM18, Syria

About this study

One main issue in orthodontics is the prolonged treatment time, leading patients, especially adults, to avoid treatment or seek alternative options such as implants or veneers with less than optimal results.

Therefore, the search for methods that decrease the treatment duration is a main challenge in orthodontic research. Decreased duration of therapy seems to be related not only to better patient compliance, but also to reduced treatment -related root resorption , better periodontal health and lower risk of caries and white spots. Adjunct to the proper selection of brackets, wires, biomechanic systems, force levels, and anchorage systems, an array of novel techniques has been introduced to accelerate orthodontic tooth movement. These techniques can be briefly categorized as surgical and non-surgical. However The surgical approach is the most clinically used and most tested with known predictions and stable results. The invasiveness of surgical procedures, requiring full mucoperiosteal flaps, might have been a drawback for their widespread acceptance among orthodontists and patients. Therefore, more conservative flapless corticotomy techniques have recently been proposed. Although various techniques of flapless corticotomy have been reported to be successful in practice, scientific evidence for their effectiveness so far has been limited to case series and a handful of clinical trials, generally with small groups. Therefore further controlled prospective studies are needed to study the effectiveness of flapless corticotomy in accelerating orthodontic tooth movement .

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: 15-27 years.
  • Class II Division 1 malocclusion :
  • Mild / moderate skeletal Class II (sagittal discrepancy angle ≤7)
  • Overjet ≤10
  • Normal or excessive facial height (Clinically and then cephalometrically assessed using these three angles : mandibular/cranial base angle, maxillary/mandibular plane angle and facial axis angle)
  • Mild to moderate crowding ≤ 4
  • Permanent occlusion.
  • Existence of all the upper 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, nonsteroidal antiinflammatory drugs (NSAIDs), …)
  • patients have anti indication for oral surgery ( medical - social - psycho)
  • Presence of primary teeth in the maxillary arch
  • Missing permanent maxillary 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

Corticotomy cuts will be performed by this technique.

ER:YAG laser

Radiation

Corticotomy cuts will be performed by this technique.

Primary outcomes

  1. Rate of canine retraction

    Time frame: This will be measured immediately at the end of the tooth movement, i.e. when the retracted canine reaches its final position which takes up to 12 weeks

    The distance traveled by mm is divided by the time required in weeks.

Secondary outcomes

  1. Rate of molar anchorage loss

    Time frame: This will be measured immediately at the end of the tooth movement, i.e. when the retracted canine reaches its final position which may take up to 12 weeks

    The amount of mesial movement of the first molar in millimeters (mm) is divided by the time required to retract the upper canines (in weeks).

  2. Change in canine rotation

    Time frame: This will be measured at the following assessment times: T1: baseline, T2: after 4 weeks of canine retraction, T3: after 8 weeks of canine retraction, T4: when the canine reaches its final position up to 12 weeks

    This measurement will be performed on plaster models taken at the aforementioned assessment times.

  3. Change in the levels of pain and discomfort

    Time frame: These levels will be assessed at: one day following the intervention, one week, two weeks, and four weeks following the intervention.

    Assessment will be performed using questionnaires via visual analog scales.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Evaluation the Efficacy of Flapless Corticotomy Accomplished by Either Hard-laser or Piezosurgey in Accelerating Upper Canine Retraction and Evaluation of the Dento-alveolar Changes and the Levels of Acceptance and Discomfort.

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 17, 2015
Registry last updated
Jun 10, 2016

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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