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Completed
NCT05652244
Evaluation of the Levels of Pain, Discomfort, and Functional Impairment With Two Techniques of Retraction
Conditions: Class II Malocclusion
Sex: All
Ages: 17 Years – 27 Years
Phase: NA
Enrollment: 38
Sponsor: Damascus University
Location: Syrian Arab Republic
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.
Eligibility Criteria
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 mmNo radiographic evidence of bone loss.Gingival index ≤ 1Plaque index ≤ 1Exclusion Criteria:Medical conditions that affect tooth movement (corticosteroid, nonsteroidal anti-inflammatory drugs (NSAIDs), …)Presence of primary teeth in the maxillary archAny craniofacial syndromes.Poor oral hygiene or Current periodontal disease:The patient had previous orthodontic treatment
Source: ClinicalTrials.gov (NCT05652244). StuddyBuddy aggregates publicly available trial information.
