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NCT Number: NCT03999307

Low-Level Laser Therapy and Flapless Corticopuncture Effect on Accelerating Six Maxillary Anterior Teeth Retraction

The long time needed for orthodontic treatment is considered one of the biggest obstacles that make patients refuse to undergo orthodontic treatment. It also has many disadvantages including higher caries rates, gingivitis, and root resorption. Therefore, the purpose of this study is to evaluate the efficiency of two new noninvasive methods (Low-Level Laser Therapy and Corticopuncture) in accelerating orthodontic tooth movement for the implant supported En-Masse retraction of the six maxillary anterior teeth.

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Key information

Conditions

Malocclusion, Angle Class II, Division 1 Malocclusion Malocclusion, Angle Class II Stomatognathic Diseases Tooth Diseases

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dental Medicine, Damascus University

Damascus, Syria

About this study

This study will be a randomized controlled trial with a 1:1:1 allocation ratio. Sample size was calculated using Minitab version 15. 36 Participants recruited from patients attending the Department of Orthodontics and Dentofacial Orthopedics at Damascus University with class II division 1 malocclusion that indicates the extraction of first maxillary premolars will be randomly assigned into one of three groups: Low-Level Laser Therapy (LLLT) group, flapless corticopuncture group, or control group. Titanium mini-implants (1.6 mm diameter and 7 mm length) will be inserted between the maxillary second premolar and first molar at approximately 8-10 mm height above the archwires below the mucogingival junction. After complete leveling and alignment of the maxillary dental arch, which will be defined by passive insertion of 19*25 inch S.S. archwire, the retraction stage of the six maxillary anterior teeth will begin.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient age between (18 - 24) years.
  • Class II Division 1 malocclusion that indicates extraction of two maxillary first premolars with the following parameters:

ANB: 5 to 10 degrees. Overjet: 5 to 10 mm. Growth Pattern: normal or slightly vertical.

  • All upper teeth are existed (Except for third molars).
  • Mild to moderate crowding (3 mm or less).
  • Patient dose not undergo any medical treatment that interfere with orthodontic tooth movement (Cortisone, NSAIDs, …).
  • Good oral hygiene (Plaque index < 1).

Exclusion criteria

  • Any medical condition affecting orthodontic tooth movement.
  • Poor oral hygiene (Plaque index > 1).
  • Patient did not undergo previous orthodontic treatment.
  • Patient lack of commitment toward follow-up appointments.

Treatment and study plan

low-level laser therapy (LLLT)

Radiation

LLLT will be applied in this group

Flapless Corticopunture

Procedure

Small holes in the cortical bone will be achieved using 1-mm diameter round surgical Tungsten bur

Control

Other

Typical orthodontic treatment with no LLLT or flapless corticopuncture

Primary outcomes

  1. Duration of en-masse retraction of the six maxillary anterior teeth

    Time frame: The months required to complete the retraction procedure will be recorded, which is expected to be occur within four months

    Assessment will be performed by calculating the time required from the beginning of the six maxillary anterior teeth retraction till the completion of this procedure

  2. Rate of en-masse retraction of the six maxillary anterior teeth

    Time frame: The calculation of the rate of retraction will be done once the retraction procedure has finished which is expected to occur within four months

    Assessment will be performed on study models by dividing the distance that the six maxillary anterior teeth moved during retraction to the time required to retract them to their ideal positions.

Secondary outcomes

  1. Maxillary first molar anchorage loss

    Time frame: This outcome will be measured one day before upper incisors' retraction initiation (T0) and immediately after the completion of retraction (T1) which is expected to occur in 4 months

    Assessment will be performed on study casts by calculating the amount of mesial drifting of the maxillary molar (if any) in millimeters before and after retraction

  2. Root resorption

    Time frame: A CBCT image will be taken one day before the six maxillary incisors retraction initiation (T0) and immediately after the completion of retraction (T1) which is expected to occur in 4 months

    Assessment will be performed by subtracting the root length of each maxillary anterior tooth after retraction from its length before starting retraction procedure.

  3. Changes in the gingival indices

    Time frame: This outcome will be measured one day before the six maxillary incisors retraction initiation (T0) and immediately after the completion of retraction (T1) which is expected to occur in 4 months

    Assessment will be performed clinically using the WHO probe

  4. Change in tooth vitality (the response of the pulp tissue toward external stimuli)

    Time frame: This outcome will be measured one day before the six maxillary anterior teeth retraction initiation (T0) and immediately after the completion of retraction (T1) which is expected to occur in 4 months

    Tooth vitality will be evaluated for each tooth of the six maxillary anterior teeth using Ethyl Chloride applied by a cotton roll on each tooth, which will indicate negative response (no vitality) or positive response (vital pulp)

  5. Changes in the levels of pain and discomfort

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

    Assessment will be performed using questionnaires that include Visual Analog Scale (VAS) for each question, the scale has a minimum scale of 0 (no pain or discomfort) and a maximum scale of 100 (maximum pain or discomfort).

  6. Change in the Oral Health Related Quality of Life associated with anterior teeth retraction.

    Time frame: The OHIP-14 will be assessed immediately after application, after 1, 7, 14, and 28 days of the six maxillary anterior teeth retraction initiation

    Assessment will be performed using the OHIP-14 questionnaire; which is a questionnaire that include 14 questions regarding different aspects of problems that might be associated with retraction (discomfort, stress, chewing difficulties, ...). the patient could choose the answer from a five-point Likert scale (Never, Hardly ever, Occasionally, Fairly often, Very often)

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Evaluation of Low-Level Laser Therapy (LLLT) and Flapless Corticopuncture Effect on Accelerating Implant-Supported En-Masse Retraction of the Six Maxillary Anterior Teeth (Clinical Randomized Controlled Trial)

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 26, 2019
Registry last updated
Jan 20, 2021

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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