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Completed

NCT Number: NCT05250921

Evaluation of the Patient Experience With a Surgically-assisted Acceleration Method of Orthodontic Treatment

The duration of orthodontic treatment is one of the exacerbation causes of orthodontic pain. Several methods have been suggested to reduce the duration of orthodontic treatment classified to surgical and non-surgical methods.

Researches used minimally invasive surgical methods like corticision, piezocesion, disicion, micro-osteoperforation, and piezopuncture indicated that most of these methods can accelerate dental movement by 20 - 40% without causing additional pain as a result of using those methods.

Applying corticision on the lower anterior teeth using a surgical blade and a hammer may accelerate tooth alignment during orthodontic treatment. This study consists of two groups, patients will be randomly assigned to one of these two groups.

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Key information

Conditions

Crowding, Tooth Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Malocclusion Neoplasms Neoplasms by Histologic Type Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Tooth Diseases

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Damascus

Damascus, Syria

About this study

Pain is defined as an unpleasant emotional sensory experience associated with actual or potential harm. It was mentioned as one of the most common complaints related to orthodontic treatment, and around 65-95% of patients undergoing orthodontic treatment suffer from various degrees of pain.

Corticision is one of the minimally invasive surgical procedures that is not associated with flap lifting. It was used to accelerate tooth movement in animals and case report studies. Its application on humans may aggravate their fear and anxiety towards the pain that may accompany this technique.

No study in the literature has been searched in patient perception of pain, discomfort, levels of acceptance and satisfaction accompanied corticision application application, but in this study, these previous variables accompanied corticision technique have been studied on crowded lower anterior teeth cases which are one of the most common types of malocclusions.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age range between 18 and 24 years
  • Completion of permanent dentition (except third molars)
  • Mild to moderate crowding (2-6 mm according to Little's index)
  • Absence of medications intake that interferes with pain perception for at least one week before the beginning of the treatment

Exclusion criteria

  • Systematic diseases that could affect bone and tooth movement and no contraindication avoid oral surgery
  • Medical conditions that affect tooth movement (Corticosteroid, NSAIDs)
  • Patients had previous orthodontic treatments
  • Poor oral hygiene or concurrent periodontal disease

Treatment and study plan

Corticision

Procedure

Corticision will be performed to enhance teeth alignment.

Conventional fixed appliance

Device

No surgical intervention is going to be applied to the patients in this group.

Primary outcomes

  1. Change in the levels of pain

    Time frame: at 1, 7, 14 days following the onset of orthodontic treatment

    Pain is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of pain being experienced. The left end of the line refers to no pain (VAS=0) where the right end refers to maximum (unimaginable) pain (VAS=100). The level of pain is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the pain.

  2. Change in the levels of discomfort:

    Time frame: at 1, 7, 14 days following the onset of orthodontic treatment

    discomfort is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of discomfort being experienced. The left end of the line refers to no discomfort (VAS=0) where the right end refers to maximum discomfort (VAS=100). The level of discomfort is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the discomfort.

  3. Change in the levels of swelling

    Time frame: at 1, 7, 14 days following the onset of orthodontic treatment

    swelling is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of swelling being experienced. The left end of the line refers to no swelling (VAS=0) where the right end refers to maximum swelling (VAS=100). The level of swelling is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the swelling.

  4. Change in the perception of mastication problems:

    Time frame: at 1, 7, 14 days following the onset of orthodontic treatment

    difficulties of mastication are assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of difficulties in mastication being experienced. The left end of the line refers to no difficulties (VAS=0) where the right end refers to maximum difficulties (VAS=100). The level of difficulties in mastication are represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the difficulties of mastication.

  5. Number of analgesic tables taken

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

    The number of tablets used: Patients in both groups were asked about taking analgesics and their quantity (mg) They answered about taking analgesics using a two-point scale (1. Yes or 2. No), and their quantity by mentioning how many tablets they took.

Secondary outcomes

  1. Satisfaction using VAS:

    Time frame: At the end of leveling and alignment

    Definition: satisfaction is assessed for both groups by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of satisfaction. The left end of the line refers to no satisfaction (VAS=0) where the right end refers to maximum satisfaction (VAS=100). The level of satisfaction is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the satisfaction.

  2. Satisfaction with the ease of the procedure

    Time frame: At the end of leveling and alignment

    is assessed for both groups by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of ease. The left end of the line refers to no ease (VAS=0) where the right end refers to maximum ease (VAS=100). The grade of ease is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the ease of the procedure.

  3. Satisfaction through acceptability of the procedure

    Time frame: At the end of leveling and alignment

    Patients in corticision group were asked about possibility of repeating the procedure, and they answered using a two-point scale (1. Yes or 2. No).

  4. Satisfaction through recommending the procedure

    Time frame: At the end of leveling and alignment

    Recommendation to a friend: Patients in corticision group were asked about making recommendation to a friend, and they answered using a two-point scale (1. Yes or 2. No).

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

The Effect of Corticision on Perceived Pain and Discomfort for Patients With Crowded Lower Anterior Teeth in Young Adult Patients: Randomized Clinical Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 22, 2022
Registry last updated
Feb 22, 2022

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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