Skip to main content
OpenTrials
Completed

NCT Number: NCT05920525

Pain, Discomfort, and Acceptance During Using Electrical Stimulation to Accelerate Orthodontic Teeth Movement

Forty patients with class II division 1 malocclusion who will require extraction of the upper first premolars as a part of the orthodontic treatment plan will be invited to participate in the study. They will be divided randomly into two groups: the electrical group and the control group. The en-masse retraction technique will be used to retract the upper anterior teeth using mini-implants as an anchor unit to provide the maximum anchorage and Nickle-Titanium closed coil springs that will be stretched from the mini-implants to the crimpable hooks on the base wire and applied 250 g of force per side.

A special removable electrical device will be used to provide electrical stimulation during the retraction phase.

The levels of pain and discomfort will be self-reported using a questionnaire with visual analog scales.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

17 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthodontics, Faculty of Dentistry, University of Damsacus

Damascus, DM20 HAJ72, Syria

About this study

Participants will be chosen from the patients attending the Department of Orthodontics in the Faculty of Dentistry at Damascus University. patients will be examined by the researcher, and any patient with class II division I malocclusion who meets the inclusion criteria will invite to participate in this trial. After giving them the information sheet, informed consent will be obtained from all patients who agreed to join the study.

Leveling and alignment will be performed using pre-adjusted fixed orthodontic appliances of 0.022 x 0.028-inch slot metal bracket with MBT prescription; the conventional wiring sequence will be followed until a 0.019 x 0.025 Stainless Steel base wire is attached.

The maxillary first premolars will be extracted, and skeletal anchoring will be applied before leveling and alignment will begin for all patients. self-drilling orthodontic mini-implants (diameter: 1.6 mm; length: 8 mm) will be placed between the roots of the maxillary second premolar and the first molar on each side.

The en-masse retraction will be done using Nickle-Titanium (NiTi) closed coil springs that stretched from crimpable hooks on the base wire to the mini-implants and applied 250 g of force per side. The force will be examined using a force gauge at every appointment (two weeks) until the completion of the retraction of the upper anterior (reaching a class I canine relationship and a correct incisor relationship).

A micro electrical current will be applied on the upper anterior teeth area using a removable intraorally device containing a small electrical circuit. Each patient in the experimental group will be asked to apply the electric accelerating device in the mouth for 5 hours daily.

The levels of pain and discomfort will be self-reported using a questionnaire with visual analog scales. 24 hours following the springs activation (T1), three days (T2), and one week (T3).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult healthy patients of both sexes
  • Age range: 17-25 years.
  • Class II Division 1 malocclusion:
  • Mild to moderate skeletal Class II (ANB = 5-7)
  • Protrusion less than 10 mm (5 to 10 mm of overjet)
  • Normal or vertical growth pattern (MM ≥ 26; SN-MP ≥ 33; Y Axis ≥ 65)
  • Dental crowding less than 3 mm
  • The presence of all permanent upper teeth (regardless of 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

  • Patients with previous orthodontic treatment.
  • Patients with severe skeletal dysplasia in all three dimensions.
  • Patients suffer from systemic diseases or syndromes
  • Patients on medication for systemic disorders, pregnancy, or steroid therapy.
  • Patients showing any signs of active periodontal disease

Treatment and study plan

Electrical Stimulation

Device

A specific device will be used to stimulate the remodeling procedures in the alveolar bone.

Traditional retraction of the front upper teeth

Procedure

The retraction will be performed using coil springs which will help in moving the anterior teeth backward without the need to employ any additional procedure or device to accelerate this movement.

Primary outcomes

  1. Change in the perception of pain

    Time frame: Questionnaires will be filled at the following assessment times: at the 1st, 3rd, and 7th day of the first, second, and third months from the beginning of the en-masse retraction of upper anterior teeth

    Patients will be asked this question about their perception of pain. 'What is the degree of pain accompanying this moment?' 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), whereas the right end refers to maximum (unimaginable) pain (VAS=100).

  2. Change in the perception of discomfort

    Time frame: Questionnaires will be filled at the following assessment times: at the 1st, 3rd, and 7th day of the first, second, and third months from the beginning of the en-masse retraction of upper anterior teeth

    Patients will be asked this question about their perception of discomfort. 'What is the degree of discomfort that accompanies this moment?' 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), whereas the right end refers to maximum (unimaginable) discomfort (VAS=100).

Secondary outcomes

  1. Change in the perception of burning

    Time frame: Questionnaires will be filled at the following assessment times: at the 1st, 3rd, and 7th day of the first, second, and third months from the beginning of the en-masse retraction of upper anterior teeth

    Patients will be asked this question about their perception of burning. 'Do you feel any burning in the upper anterior teeth area?' burning is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of burning being experienced. The left end of the line refers to no burning (VAS=0), whereas the right end refers to maximum (unimaginable) burning (VAS=100).

  2. Change in the perception of swelling

    Time frame: Questionnaires will be filled at the following assessment times: at the 1st, 3rd, and 7th day of the first, second, and third months from the beginning of the en-masse retraction of upper anterior teeth

    Patients will be asked this question about their perception of swelling. 'Do you feel any Swelling in the upper anterior teeth area?' 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), whereas the right end refers to maximum (unimaginable) Swelling (VAS=100).

  3. Change in the chewing ability

    Time frame: Questionnaires will be filled at the following assessment times: at the 1st, 3rd, and 7th day of the first, second, and third months from the beginning of the en-masse retraction of upper anterior teeth

    Patients will be asked this question about their perception of chewing ability. 'what is the degree of chewing difficulties? ' difficulty in chewing is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of difficulty in swallowing being experienced. The left end of the line refers to no difficulty (VAS=0), whereas the right end refers to the maximum difficulty in mastication.

  4. Change in the speech ability

    Time frame: Questionnaires will be filled at the following assessment times: at the 1st, 3rd, and 7th day of the first, second, and third months from the beginning of the en-masse retraction of upper anterior teeth

    Patients will be asked this question about their perception of speech ability. ''what is the degree of speech difficulties?' Difficulty in speech is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of difficulty in speech being experienced. The left end of the line refers to no difficulty (VAS=0), whereas the right end refers to maximum (unimaginable) difficulty (VAS=100).

  5. Analgesic consumption

    Time frame: Questionnaires will be filled at the following assessment times: at the 1st, 3rd, and 7th day of the first, second, and third months from the beginning of the en-masse retraction of upper anterior teeth

    Patients will be asked this question about "Analgesic Consumption". 'Did you need to take pain analgesics?' Analgesic Consumption is assessed by asking the study participant about taking analgesics using a two-point scale (1. Yes, or 2. No).

  6. Patients' satisfaction

    Time frame: Questionnaires will be filled at the end of the fifth month of the en-masse retraction

    Patients will be asked this question about satisfaction with orthodontic treatment.

    'How satisfied are you with your orthodontic treatment?' 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), whereas the right end refers to maximum satisfaction (VAS=100).

  7. Ease of the procedure

    Time frame: Questionnaires will be filled at the end of the fifth month of the en-masse retraction

    Patients will be asked this question about the ease of the procedure. 'Was it getting used to the accelerating device? ' The procedure's easiness is assessed by asking the participant in the experimental group using a three-point scale (1. easy, 2. Medium, or 3. difficult).

  8. The possibility of repeating the procedure

    Time frame: Questionnaires will be filled at the end of the fifth month of the en-masse retraction

    Patients will be asked this question about "The possibility of repeating the procedure.

    'Would you accept to undergo this treatment again?' Patients in the experimental group will be asked about the possibility of repeating the procedure if they can give their decision again. The answer will be collected using a two-point scale (1. Yes, or 2. No).

  9. Recommendation of the procedure to a friend

    Time frame: Questionnaires will be filled at the end of the fifth month of the en-masse retraction

    Patients will be asked this question about the possibility of recommending the procedure to their friends.

    'Would you recommend a friend to undergo this treatment?' Patients in the experimental group will be asked if they would recommend this procedure to a friend. The answer will be collected using a two-point scale (1. Yes, or 2. No).

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Evaluation of Patient-reported Outcome Measures (PROMs) During Accelerating the En-masse Retraction of Upper Anterior Teeth Using a Low-intensity Direct Electrical Current: A Randomized Controlled Clinical Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jun 27, 2023
Registry last updated
Jun 27, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.