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

NCT ID: NCT05652244

Last Updated: 2022-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-13

Study Completion Date

2015-01-24

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Class II Malocclusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Retraction with mini-implants

Mini-implants will be used as an anchor unit.

Group Type EXPERIMENTAL

Mini-implants

Intervention Type 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.

Retraction with transpalatal arches

Transpalatal arches will be used as an anchor unit.

Group Type ACTIVE_COMPARATOR

Transpalatal arche (TPA)

Intervention Type 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.

Interventions

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Mini-implants

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.

Intervention Type DEVICE

Transpalatal arche (TPA)

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Adult healthy patients, Male and female, Age range: 17-27 years.
2. 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

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

17 Years

Maximum Eligible Age

27 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damascus University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Salma Al-Sibaie, DDS,MSc

Role: PRINCIPAL_INVESTIGATOR

Department of Orthodontics, University of Al-Baath Dental School, Hamah, Syria

Mudar Mohammad Mousa, DDS

Role: PRINCIPAL_INVESTIGATOR

Department of orthodontics, Damascus University, Syria

Mohammad Y. Hajeer, DDS,MSc,PhD

Role: STUDY_DIRECTOR

Department of orthodontics, Damascus University, Syria

Locations

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University of Damascus

Damascus, , Syria

Site Status

Countries

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Syria

References

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Oliver RG, Knapman YM. Attitudes to orthodontic treatment. Br J Orthod. 1985 Oct;12(4):179-88. doi: 10.1179/bjo.12.4.179.

Reference Type BACKGROUND
PMID: 3863673 (View on PubMed)

Haynes S. Discontinuation of orthodontic treatment relative to patient age. J Dent. 1974 Jul;2(4):138-42. doi: 10.1016/0300-5712(74)90041-4. No abstract available.

Reference Type BACKGROUND
PMID: 4531440 (View on PubMed)

Feldmann I, List T, Feldmann H, Bondemark L. Pain intensity and discomfort following surgical placement of orthodontic anchoring units and premolar extraction: a randomized controlled trial. Angle Orthod. 2007 Jul;77(4):578-85. doi: 10.2319/062506-257.1.

Reference Type BACKGROUND
PMID: 17605489 (View on PubMed)

Lehnen S, McDonald F, Bourauel C, Jager A, Baxmann M. Expectations, acceptance and preferences of patients in treatment with orthodontic mini-implants: part II: implant removal. J Orofac Orthop. 2011 Jul;72(3):214-22. doi: 10.1007/s00056-011-0026-3. English, German.

Reference Type BACKGROUND
PMID: 21744200 (View on PubMed)

Lehnen S, McDonald F, Bourauel C, Baxmann M. Patient expectations, acceptance and preferences in treatment with orthodontic mini-implants. A randomly controlled study. Part I: insertion techniques. J Orofac Orthop. 2011 Mar;72(2):93-102. doi: 10.1007/s00056-011-0013-8. English, German.

Reference Type BACKGROUND
PMID: 21503849 (View on PubMed)

Other Identifiers

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UDDS-Ortho-16-2022

Identifier Type: -

Identifier Source: org_study_id