Class II Malocclusion Clinical Trial
Official 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
Verified date | December 2022 |
Source | Damascus University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 38 |
Est. completion date | January 24, 2015 |
Est. primary completion date | May 3, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 17 Years to 27 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Syrian Arab Republic | University of Damascus | Damascus |
Lead Sponsor | Collaborator |
---|---|
Damascus University |
Syrian Arab Republic,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Oliver RG, Knapman YM. Attitudes to orthodontic treatment. Br J Orthod. 1985 Oct;12(4):179-88. doi: 10.1179/bjo.12.4.179. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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