Malocclusion Clinical Trial
Official title:
Evaluation of the Efficacy of One-jaw Versus Tow-jaw Mechanics for Mini-implants Anchored Total-maxillary-arch-distalization in the Treatment of Class II Division 1 Malocclusion A Randomized Controlled Trial
Verified date | March 2021 |
Source | Hama University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients with class II division 1 malocclusion who have increased overjet will be treated in this study. The efficacy of one-jaw and tow-jaw mechanics for mini-implants anchored total-maxillary-arch-distalization in the treatment of class II division 1 malocclusion will be assessed. The skeletal, dental and soft tissues changes resulted by these tow interventions will be studied. As well as, the pain levels, oral-health related quality of life during all stages of the treatment and the smile components will be explored and compared with the traditional treatment results of this type of malocclusion (en-mass retraction with first premolars extraction). There are three groups : 1. a group of patients in which participants will be undergo to the one-jaw mechanic for mini-implants anchored total-maxillary-arch-distalization (mini-implants in the maxillary arch). 2. a group of patients in which participants will be undergo to the tow-jaw mechanic for mini-implants anchored total-maxillary-arch-distalization (mini-implants in the mandibular arch with class II elastics). 3. a group of patients in which participants will be undergo to the en-mass retraction with first premolars extraction with mini-implants in the maxillary arch.
Status | Completed |
Enrollment | 48 |
Est. completion date | August 1, 2022 |
Est. primary completion date | July 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 17 Years to 30 Years |
Eligibility | Inclusion Criteria: - Adult patients with permanent occlusion at age 18-30 years. - Comprehensive medical and dental history ruling out any systemic disease - Not under any systemic medication. - No previous orthodontic treatment - Patients with satisfactory periodontal health and Good oral hygiene - Need to orthodontic treatment with fixed appliances - No congenitally missing teeth except third molars in the maxillary arch - Mild or no anterior crowding in maxillary arch. - Patients with class ? division 1 (ANB angle =7 degrees) with severe overjet (5-9 mm) - Maximum retraction of the anterior teeth was desired. Exclusion Criteria: - Patients with previous orthodontic treatment. - Patients with severe skeletal dysplasia in all three dimensions. - Patients suffer from systemic diseases or syndromes - Patients on medication for systemic disorders, pregnancy or steroid therapy. - Patients showing any signs of active periodontal disease - Patients with severe crowding (= 3.5 mm) in maxillary arch - Patients with missing or extracted teeth in maxillary arch except third molar. |
Country | Name | City | State |
---|---|---|---|
Syrian Arab Republic | Syrian Arab Republic -Department of Orhodontic, University of Hama | Hama | Hama City |
Lead Sponsor | Collaborator |
---|---|
Hama University |
Syrian Arab Republic,
Bechtold TE, Kim JW, Choi TH, Park YC, Lee KJ. Distalization pattern of the maxillary arch depending on the number of orthodontic miniscrews. Angle Orthod. 2013 Mar;83(2):266-73. doi: 10.2319/032212-123.1. Epub 2012 Sep 12. — View Citation
Chen G, Teng F, Xu TM. Distalization of the maxillary and mandibular dentitions with miniscrew anchorage in a patient with moderate Class I bimaxillary dentoalveolar protrusion. Am J Orthod Dentofacial Orthop. 2016 Mar;149(3):401-10. doi: 10.1016/j.ajodo.2015.04.041. — View Citation
Choi YJ, Lee JS, Cha JY, Park YC. Total distalization of the maxillary arch in a patient with skeletal Class II malocclusion. Am J Orthod Dentofacial Orthop. 2011 Jun;139(6):823-33. doi: 10.1016/j.ajodo.2009.07.026. — View Citation
Jo SY, Bayome M, Park J, Lim HJ, Kook YA, Han SH. Comparison of treatment effects between four premolar extraction and total arch distalization using the modified C-palatal plate. Korean J Orthod. 2018 Jul;48(4):224-235. doi: 10.4041/kjod.2018.48.4.224. Epub 2018 Jul 6. — View Citation
Park CO, Sa'aed NL, Bayome M, Park JH, Kook YA, Park YS, Han SH. Comparison of treatment effects between the modified C-palatal plate and cervical pull headgear for total arch distalization in adults. Korean J Orthod. 2017 Nov;47(6):375-383. doi: 10.4041/kjod.2017.47.6.375. Epub 2017 Sep 29. — View Citation
Shoaib AM, Park JH, Bayome M, Abbas NH, Alfaifi M, Kook YA. Treatment stability after total maxillary arch distalization with modified C-palatal plates in adults. Am J Orthod Dentofacial Orthop. 2019 Dec;156(6):832-839. doi: 10.1016/j.ajodo.2019.01.021. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of the treatment | Assessment will be performed by calculating the months required to achieve a normal overjet and canines class I relationships through clinical examination | duration (in months) between T0: the beginning of active treatment, T1: when a normal overjet and canines class I relationships achieved. (expected to be within 6 months in the exp. groups and 8 months in the control group) | |
Primary | Change in the Incisors' positions | Amount of distance being traveled by the retracted anterior teeth is going to be measured on study models taken when a normal overjet and canines class I relationships will be achieved. | : T0: 1 day before the beginning of active treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6 months in the exp. groups and 8 months in the control group | |
Primary | Change in Molars' positions | Amount of distance being traveled by the first molars and is going to be measured on study models taken when a normal overjet and canines class I relationships will be achieved. | : T0: 1 day before the beginning of active treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6 months in the exp. groups and 8 months in the control group | |
Primary | Change in the SNA angle | This angle represents the position of the upper jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees. | : T0: 1 day before the beginning of active treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6 months in the exp. groups and 8 months in the control group | |
Primary | Change in the SNB angle | This angle the represents the position of the lower jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees. | : T0: 1 day before the beginning of active treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6 months in the exp. groups and 8 months in the control group | |
Primary | Change in the ANB angle | This angle the represents the spatial relationship between the upper and lower jaws in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees. | : T0: 1 day before the beginning of active treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6 months in the exp. groups and 8 months in the control group | |
Primary | Change in the SN.GoMe angle | This angle the represents the amount of backward rotation of the lower jaw in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees. | : T0: 1 day before the beginning of active treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6 months in the exp. groups and 8 months in the control group | |
Primary | Change in the MM angle | This angle the represents the amount of vertical divergence between the upper and lower jaws in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees. | : T0: 1 day before the beginning of active treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6 months in the exp. groups and 8 months in the control group | |
Primary | Change in the nasolabial angle | This angle the represents the relationship of the upper lip with the nose in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees. | : T0: 1 day before the beginning of active treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6 months in the exp. groups and 8 months in the control group | |
Secondary | Change in the levels of spontaneous and chewing pain | Assessment will be performed using questionnaires via visual analog scales (VAS).0 indicated 'no pain' and 10 indicated the 'extreme level of pain' perception. | Levels of pain will be assessed at : immediately after the begging of the distalization or retraction (T1), 6 hours (T2) , 24 hours (T3) , 48 hours (T4), 1 week (T5) and 24 hours of each force activation. | |
Secondary | Change in the smile components | The smile photographs will be analyzed using a Smile Mesh which assess the following components: Maximum incisor exposure, Upper lip drape, Lower lip to maxillary incisor, Interlabial gap, Visible posterior tooth width, Smile width, Smile index, Commissure corridor left, Commissure corridor right, Buccal corridor left, Buccal corridor right, Buccal corridor ratio, Upper lip thickness andLower lip thickness. All these components will be measured with millimeters | T0: 1 day before the beginning of the treatment . T1: at the end of the treatment (expected to be within 6 months in the exp. groups and 8 months in the control group) |
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