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Completed

NCT Number: NCT04316403

Laser-assisted Flapless Corticotomy in Accelerating Canine Retraction

Erbium lasers have been suggested to accomplish corticotomy without flap reflection due to their attractive advantages. The current trial aimed to evaluate the efficacy of laser-assisted flapless corticotomy in accelerating orthodontic tooth movement. The secondary aim was to evaluate the patients' responses to laser application. It was postulated that canine retraction after laser-assisted flapless corticotomy would be accomplished within a shorter period compared with the conventional canine retraction method, with no significant degree of pain and discomfort.

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Key information

Conditions

Class II Division 1 Malocclusion Malocclusion Malocclusion, Angle Class II Maxillary Prognathism Overbite Protrusion, Incisor Stomatognathic Diseases Tooth Diseases

Age range

16 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthodontic Department, University of Hama Dental School

Hama, 12JO76WH, Syria

About this study

Comprehensive orthodontic treatment with fixed appliances usually takes more than 18 months in mild and severe cases. Prolonged treatment time can cause many adverse effects such as pain, discomfort, external root resorption, white spots and dental caries. Decreasing the treatment time for tooth movement has been the focus of both the clinicians and the patients. For the last few decades, investigators have recommended many treatment approaches intending to reduce overall treatment time such as low friction and self-ligating bracket systems, low-level laser irradiation, electrical currents, pharmacological approaches, local platelet-rich plasma (PRP) injection and surgical approaches like dentoalveolar distraction and selective alveolar decortication or corticotomy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Class II division 1 patients requiring orthodontic treatment with fixed appliances and a need for upper first-premolar extraction using a two-step retraction technique.
  • Permanent dentition with an age range from 16 to 24 years.
  • Healthy with no systemic conditions.
  • Adequate oral hygiene and healthy periodontal tissues
  • no previous orthodontic treatment
  • Absence of canine endodontic treatment.

Exclusion criteria

  • Bimaxillary dentoalveolar severe protrusion.
  • Previous orthodontic treatment.
  • Subject with psychological abnormalities.
  • Subject with systemic diseases.

Treatment and study plan

Er:YAG laser

Procedure

This application was made before the onset of canine retraction in one side of the mouth

Primary outcomes

  1. Change in the canine retraction rate

    Time frame: 10 minutes after laser application, one, two, four, 8 and 12 weeks after laser application

    The distance between the first molar labial hook and the canine bracket hook was recorded using Digital Boely gauge and then this distance was divided by the time that passed between two assessment points.

Secondary outcomes

  1. Change in the levels of pain and discomfort

    Time frame: at the 1st day following laser application (10 minutes) and at the 3rd, 5th and 7th days following laser application

    A questionnaire was administered at the 1st, 3rd, 5th and 7th day after laser application. The questionnaire contained 5 questions (using 4-point Likert ordinal scales) to collect patients' responses on the following questions:

    Question 1: Do you feel pain during eating? Question 2: Do you feel pain during the day? Question 3: Do you feel pain that can awaken you during the night? Question 4: Do you feel swollen on the surgical side?

    The possible answers were:

    • No 2.Mild 3.Moderate 4. Severe For the first four questions, the higher the score, the worse the feeling was.

    Question 5: Which one of the following has caused more discomfort to you?

    • Extraction of premolars 2. Laser application 3.Both

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Evaluation of the Efficacy of Laser-assisted Flapless Corticotomy in Accelerating Canine Retraction: A Split-mouth Randomized Controlled Clinical Trial

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 20, 2020
Registry last updated
Mar 24, 2020

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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