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NCT Number: NCT05652244

Evaluation of the Levels of Pain, Discomfort, and Functional Impairment With Two Techniques of Retraction

Thirty-eight patients requiring extraction of maxillary first premolars will participate in the study. They will be divided randomly into two groups: an en-masse retraction group and a two-step group. In each group, anterior teeth retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side, Mini-implants will be used as an anchor unit in the en-masse retraction group, and TPA in the two-step's retraction group.

The levels of pain, discomfort, and functional impairments will be self-reported using a validated questionnaire with a 4-points Likert scale.

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Key information

Conditions

Class II Malocclusion Malocclusion Malocclusion, Angle Class II Overbite Stomatognathic Diseases Tooth Diseases

Age range

17 year–27 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Damascus

Damascus, Syria

About this study

Pain associated with orthodontic treatment is one of the undesirable complications, which negatively affects the patient's cooperation. Pain may occur due to the pressure on the periodontal ligaments induced by orthodontic forces. The perception of pain is affected by many factors related to the patient, such as age, gender, and any previous treatment experiences, which are negatively or positively reflected in the patient's cooperation. As for the factors related to the type of orthodontic treatment provided.

The levels of pain and discomfort vary with the different anchorage systems used during orthodontic treatment.

Several methods have been proposed to assure good anchorages, such as headgear, transpalatal arch (TPA) with or without a Nance button, lingual arches, bonding of second molars, or intermaxillary elastics, and recently mini-implants.

The use of mini-implants has recently become more common. The mini-implants have been used to secure absolute anchorage in en-mass retraction, canine retraction, total arch distalization, and anterior teeth intrusion. The most common usage is en-mass retraction of anterior teeth.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult healthy patients, Male and female, Age range: 17-27 years.
  • Class II Division 1 malocclusion:
  • Mild / moderate skeletal Class II (sagittal discrepancy angle 4< ANB<10)
  • Overjet more than 5 mm.
  • Normal overbite (more than 0 mm and less than 4 mm)
  • Normal or increased anterior facial height (Clinically and then cephalometrically assessed using these three angles: mandibular/cranial base angle, maxillary/mandibular plane angle, and facial axis angle)
  • well-aligned maxillary teeth with minimal crowding (≤ 4 mm according to Little's index), 3- Complete permanent dentition (except for the third molars).

4- Existence of all the upper teeth (except third molars). 5- Good oral and periodontal health:

  • Probing depth < 4 mm
  • No radiographic evidence of bone loss.
  • Gingival index ≤ 1
  • Plaque index ≤ 1

Exclusion criteria

  • Medical conditions that affect tooth movement (corticosteroid, nonsteroidal anti-inflammatory drugs (NSAIDs), …)
  • Presence of primary teeth in the maxillary arch
  • Any craniofacial syndromes.
  • Poor oral hygiene or Current periodontal disease:
  • The patient had previous orthodontic treatment

Treatment and study plan

Mini-implants

Device

En masse retraction of upper anterior teeth will be applied where mini-implants will be used as an anchor unit. Anterior teeth retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side.

Transpalatal arche (TPA)

Device

Two-step retraction of upper anterior teeth will be applied where transpalatal arches (TPAs) will be used as an anchor unit. Teeth retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side.

Primary outcomes

  1. Change in the levels of discomfort or pain

    Time frame: Time 1: after 24 hours; Time 2: on the 3rd day; Time 3: on the 7th day; Time 4: on the 14th day; Time 5: after 1 month

    The degree of pain and discomfort that patients feel will be determined using their answers to the following question (question 01):

    Do you have pain at the site of the mini-implants/transpalatal arch? ' The four-point scale will be adopted to measure the degree of pain.

  2. Change in the levels of swelling

    Time frame: Time 1: after 24 hours; Time 2: on the 3rd day; Time 3: on the 7th day; Time 4: on the 14th day; Time 5: after 1 month

    The degree of swelling that patient feel will be determined using their answers to the following question (question 02):

    ' Do you have a sense of swelling at the site of the mini-implants/transpalatal arch?' four-point scale will be adopted to measure the degree of swelling.

  3. Change in the levels of chewing difficulties

    Time frame: Time 1: after 24 hours; Time 2: on the 3rd day; Time 3: on the 7th day; Time 4: on the 14th day; Time 5: after 1 month

    The degree of chewing difficulties that patients feel will be determined using their answers to the following question (question 03):

    ' Do you have difficulty chewing ' four-point scale will be adopted to measure the degree of chewing difficulties.

  4. Change in the speaking difficulties

    Time frame: Time 1: after 24 hours; Time 2: on the 3rd day; Time 3: on the 7th day; Time 4: on the 14th day; Time 5: after 1 month

    The degree of any speech problems that patients feel will be determined using their answers to the following question (question 04):

    ' Do you avoid specific types of speech (e.g., on the phone) ' Four-point scale will be adopted to measure the degree of chewing difficulties.

  5. Change in the cleaning difficulties

    Time frame: Time 1: after 24 hours; Time 2: on the 3rd day; Time 3: on the 7th day; Time 4: on the 14th day; Time 5: after 1 month

    The degree of any cleaning difficulties that patients feel will be determined using their answers to the following question (question 05):

    ' Do you find it difficult to clean the appliance and oral cavity? ' Four-point scale will be adopted to measure the degree of chewing difficulties.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Evaluation of Pain, Discomfort and Functional Impairment Associated With the Two-step Retraction Technique Anchored With Transpalatal Arches Versus the en Masse Retraction of Upper Anterior Teeth Anchored With Mini-implants: A Randomized Controlled Clinical Trial

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Dec 15, 2022
Registry last updated
Dec 15, 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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