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NCT05652244

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

Completed NA Last updated 15 December 2022
What this trial tests

NA trial testing Mini-implants in Class II Malocclusion in 38 participants. Completed in 24 January 2015.

Timeline
13 January 2013
Primary endpoint
3 May 2014
24 January 2015

Quick facts

Lead sponsorDamascus University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment38
Start date13 January 2013
Primary completion3 May 2014
Estimated completion24 January 2015
Sites1 location across Syria

Drugs / interventions tested

Conditions studied

Sponsor

Damascus University

Who can join

Adults 17 to 27, any sex, with Class II Malocclusion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Evaluation of the Patient-Reported Outcome Measures (PROMs) With Temporary Skeletal Anchorage Devices in Fixed Orthodontic Treatment: A Systematic Review.
    Mousa MM, Hajeer MY, Sultan K, Almahdi WH, et al · · 2023 · cited 15× · PMID 36937120 · DOI 10.7759/cureus.36165
  2. Pain, Discomfort, and Functional Impairments When Retracting Upper Anterior Teeth Using Two-Step Retraction With Transpalatal Arches Versus En-Masse Retraction With Mini-implants: A Randomized Controlled Trial.
    Mousa MM, Al-Sibaie S, Hajeer MY. · · 2023 · cited 11× · PMID 36636520 · DOI 10.7759/cureus.33524

Verify or expand the search:

Other recruiting trials for Class II Malocclusion

Currently open trials in the same condition.

Other Damascus University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05652244.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing