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

NCT05652244 | Completed DMC

• 1 other identifier: UDDS-Ortho-16-2022
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Class II Malocclusion

Outcome Measures

Primary Outcomes (5)

• Change in the levels of discomfort or pain

  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.

  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

• Change in the levels of swelling

  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.

  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

• Change in the levels of chewing difficulties

  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.

  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

• Change in the speaking difficulties

  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.

  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

• Change in the cleaning difficulties

  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.

  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

Study Arms (2)

Retraction with mini-implants

EXPERIMENTAL

Mini-implants will be used as an anchor unit.

Device: Mini-implants

Retraction with transpalatal arches

ACTIVE COMPARATOR

Transpalatal arches will be used as an anchor unit.

Device: Transpalatal arche (TPA)

Interventions

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.

Retraction with mini-implants

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.

Retraction with transpalatal arches

Eligibility Criteria

• Age: 17 Years - 27 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

University of Damascus

Damascus, Syria

Location

Related Publications (5)

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

  PMID: 3863673 BACKGROUND

• 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.

  PMID: 4531440 BACKGROUND

• 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.

  PMID: 17605489 BACKGROUND

• 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.

  PMID: 21744200 BACKGROUND

• 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.

  PMID: 21503849 BACKGROUND

MeSH Terms

Conditions

Overbite

Interventions

Dental Implants

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Salma Al-Sibaie, DDS,MSc

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

  PRINCIPAL INVESTIGATOR

• Mudar Mohammad Mousa, DDS

  Department of orthodontics, Damascus University, Syria

  PRINCIPAL INVESTIGATOR

• Mohammad Y. Hajeer, DDS,MSc,PhD

  Department of orthodontics, Damascus University, Syria

  STUDY DIRECTOR

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: December 7, 2022
• First Posted: December 15, 2022
• Study Start: January 13, 2013
• Primary Completion: May 3, 2014
• Study Completion: January 24, 2015
• Last Updated: December 15, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)