Class II Division 1 Malocclusion Clinical Trial
Official title:
Evaluation of the Levels of Pain and Discomfort Associated With Traditional or Flapless Corticotomy-assisted Maxillary En-masse Retraction: a Single- Center, Randomized Controlled Clinical Trial
Verified date | September 2021 |
Source | Damascus University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to estimate the levels of pain and discomfort associated with the en-masse retraction of the six upper anterior teeth and assisted by either conventional or flapless corticotomy. Thirty-four adult patients exhibiting class П division 1 malocclusion will be randomly allocated to either the conventional corticotomy group or the flapless corticotomy group, and they will be treated by extraction of maxillary first premolars with applying mini-screws between maxillary second premolar and first molar as temporary skeletal anchorage devices (TSADs). The levels of pain and discomfort will be rated after 24 hours of corticotomy (T1), four days (T2), seven days (T3), 14 days (T4) and after 28 days of corticotomy, by asking the patients to fill in a questionnaire for assessing levels of pain and discomfort.
Status | Completed |
Enrollment | 34 |
Est. completion date | May 15, 2019 |
Est. primary completion date | July 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility | Inclusion Criteria: 1. Age range between 18 and 30 years. 2. Class II division 1 malocclusion requiring extraction of upper first premolars. 3. Mild to moderate skeletal class II malocclusion. 4. Normal or excessive anterior facial height. 5. No or mild crowding (tooth-size arch-length discrepancy =3 mm). 6. Overjet >5 mm and <10 mm. 7. Completion permanent dentition (regardless of third molars). 8. No previous orthodontic treatment. 9. No drug use or systematic disease that would affect the bone and tooth movement rate. 10. Healthy periodontium and good oral hygiene. Exclusion Criteria: 1. Patients with previous orthodontic treatment. 2. Patients with severe skeletal dysplasia in all three dimensions. 3. Patients suffer from systemic diseases or syndromes 4. Patients on medication for systemic disorders, pregnancy or steroid therapy. 5. Patients showing any signs of active periodontal disease 6. Patients with severe crowding (= 3.5 mm) in maxillary arch 7. Patients with missing or extracted teeth in maxillary arch except third molar. |
Country | Name | City | State |
---|---|---|---|
Syrian Arab Republic | Department of Orthodontics, University of Damascus Dental School | Damascus |
Lead Sponsor | Collaborator |
---|---|
Damascus University |
Syrian Arab Republic,
Al-Sibaie S, Hajeer MY. Assessment of changes following en-masse retraction with mini-implants anchorage compared to two-step retraction with conventional anchorage in patients with class II division 1 malocclusion: a randomized controlled trial. Eur J Orthod. 2014 Jun;36(3):275-83. doi: 10.1093/ejo/cjt046. Epub 2013 Jun 20. — View Citation
Alfawal AMH, Hajeer MY, Ajaj MA, Hamadah O, Brad B, Latifeh Y. Evaluation of patient-centered outcomes associated with the acceleration of canine retraction by using minimally invasive surgical procedures: A randomized clinical controlled trial. Dent Med Probl. 2020 Jul-Sep;57(3):285-293. doi: 10.17219/dmp/120181. — View Citation
Gibreal O, Hajeer MY, Brad B. Evaluation of the levels of pain and discomfort of piezocision-assisted flapless corticotomy when treating severely crowded lower anterior teeth: a single-center, randomized controlled clinical trial. BMC Oral Health. 2019 Apr 16;19(1):57. doi: 10.1186/s12903-019-0758-9. — View Citation
Khlef HN, Hajeer MY, Ajaj MA, Heshmeh O, Youssef N, Mahaini L. The effectiveness of traditional corticotomy vs flapless corticotomy in miniscrew-supported en-masse retraction of maxillary anterior teeth in patients with Class II Division 1 malocclusion: A single-centered, randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2020 Dec;158(6):e111-e120. doi: 10.1016/j.ajodo.2020.08.008. Epub 2020 Nov 4. — View Citation
Khlef HN, Hajeer MY, Ajaj MA, Heshmeh O. En-masse Retraction of Upper Anterior Teeth in Adult Patients with Maxillary or Bimaxillary Dentoalveolar Protrusion: A Systematic Review and Meta-analysis. J Contemp Dent Pract. 2019 Jan 1;20(1):113-127. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the levels of pain perception | Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question.The scale has a minimum scale of 0 (no pain) and a maximum scale of 100 (maximum pain). | Levels of pain perception will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention | |
Primary | Change in the levels of discomfort perception | Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question.The scale has a minimum scale of 0 (no discomfort) and a maximum scale of 100 (maximum discomfort) | Levels of discomfort perception will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention | |
Secondary | Change in the levels of swelling perception | Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question | This outcome will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention | |
Secondary | Change in the levels of mastication difficulty perception | Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question | This outcome will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention | |
Secondary | Change in the levels of swallowing difficulty perception | Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question | This outcome will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention | |
Secondary | Change in the levels of Jaw movement restriction perception | Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question | This outcome will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention | |
Secondary | The levels of satisfaction | Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question | This outcome will be assessed after four weeks following the surgical intervention | |
Secondary | Which surgical intervention is more troublesome | Assessment will be performed using a three-point scale:
premolar extraction. Corticotomy procedure. Both of them are similar. |
This outcome will be assessed after four weeks following the surgical intervention | |
Secondary | Recommendation of the procedure to a friend | Assessment will be performed using a two-point scale to answer yes or no | This outcome will be assessed after four weeks following the surgical intervention |
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