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

NCT05920525 | Completed DMC

• 1 other identifier: UDDS-Ortho-11-2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Class II Malocclusion, Division 1

Keywords

Retraction of upper anterior teeth; Electrical stimulation; Coil springs

Outcome Measures

Primary Outcomes (2)

• Change in the perception of pain

  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).

  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

• Change in the perception of discomfort

  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).

  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

Secondary Outcomes (9)

• Change in the perception of burning

  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

• Change in the perception of swelling

  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

• Change in the chewing ability

  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

• Change in the speech ability

  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

• Analgesic consumption

  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

Study Arms (2)

Electrical stimulation

EXPERIMENTAL

In this group of patients, retraction of upper anterior teeth will be done using backward traction, and the remodeling will be enhanced by very light electrical stimulation by a specific device.

Device: Electrical stimulation

Traditional retraction of the front teeth

ACTIVE COMPARATOR

In this group of patients, traditional traction of the front teeth will be employed without any acceleration method.

Procedure: Traditional retraction of the front upper teeth

Interventions

Electrical stimulation DEVICE

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

Electrical stimulation

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.

Traditional retraction of the front teeth

Eligibility Criteria

• Age: 17 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Orthodontics, Faculty of Dentistry, University of Damsacus

Damascus, DM20 HAJ72, Syria

Location

Related Publications (4)

• Roth PM, Thrash WJ. Effect of transcutaneous electrical nerve stimulation for controlling pain associated with orthodontic tooth movement. Am J Orthod Dentofacial Orthop. 1986 Aug;90(2):132-8. doi: 10.1016/0889-5406(86)90045-4.

  PMID: 3488674 BACKGROUND

• Davidovitch Z, Finkelson MD, Steigman S, Shanfeld JL, Montgomery PC, Korostoff E. Electric currents, bone remodeling, and orthodontic tooth movement. II. Increase in rate of tooth movement and periodontal cyclic nucleotide levels by combined force and electric current. Am J Orthod. 1980 Jan;77(1):33-47. doi: 10.1016/0002-9416(80)90222-5.

  PMID: 6243448 BACKGROUND

• Shaadouh RI, Hajeer MY, Al-Sabbagh R, Alam MK, Mahmoud G, Idris G. A Novel Method to Accelerate Orthodontic Tooth Movement Using Low-Intensity Direct Electrical Current in Patients Requiring en-Masse Retraction of the Upper Anterior Teeth: A Preliminary Clinical Report. Cureus. 2023 May 24;15(5):e39438. doi: 10.7759/cureus.39438. eCollection 2023 May.

  PMID: 37234453 BACKGROUND

• Shaadouh RI, Hajeer MY, Mahmoud GA, Almasri IA, Jaber ST, Alam MK. Patient-reported outcomes during accelerating the en-masse retraction of the upper anterior teeth using low-intensity electrical stimulation: a randomized controlled trial. Prog Orthod. 2024 May 13;25(1):17. doi: 10.1186/s40510-024-00517-3.

  PMID: 38735912 DERIVED

MeSH Terms

Conditions

Malocclusion, Angle Class II

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Rashad Ibrahim Shaadouh, DDS

  Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2023
• First Posted: June 27, 2023
• Study Start: March 15, 2021
• Primary Completion: September 15, 2022
• Study Completion: May 15, 2023
• Last Updated: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)