Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

The number of adults seeking active orthodontic treatment has been increasing over the past several decades. Older patients tend to show a greater demand for esthetic considerations during and after active treatment. Also, the preservation of existing dentoalveolar structures becomes a more critical issue in their treatment, and this mandates vigilant monitoring of the periodontal and occlusal statuses throughout the course of tooth movement. Nowadays, the tendency towards choosing nonextraction approaches has been increasing because of the availability of effective and minimally invasive treatment modalities. Several strategies have been introduced to address the arch length discrepancy by gaining space through enamel stripping, arch expansion, and distalization of dentition. Moreover, the introduction of temporary anchorage devices (TADs) has enhanced the efficiency of nonextraction therapies via improved anchorage management. The total-maxillary-arch-distalization is a treatment modality respect the principle of structures preservation and the esthetic demands of patients. Most of the published literature were case reports or retrospective studies so, there is a high need for a randomized controlled trial to assess some of these suggested approaches. The current study will have three parallel arms as following: 1. Group 1: a group of patients in which participants will be undergo to the one-jaw mechanic for mini-implants anchored total-maxillary-arch-distalization (the mini-implants will be inserted in the maxillary arch between the roots of 2nd premolar and 1st molar and closer to the molar, then a force of 250 g will be applied from the TAD to a hook lateral to the laterals). 2. a group of patients in which participants will be undergo to the tow-jaw mechanic for mini-implants anchored total-maxillary-arch-distalization (the mini-implants will be inserted in the mandibular arch between the 2nd premolar and 1st molar, then, a class II elastics 3/16 and 6.5oz will be use from the TAD to the hook of canines brackets). 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 inserted between the 2nd premolar and 1st molar, then a force of 250 g will be applied from the TAD to a hook lateral to the laterals . Prior to enrollment of each subject into the study, they will be examined completely to determine the orthodontic treatment plan. The operator will inform them about the aim of the study and ask them to provide a written informed consent. A fixed orthodontic appliance will be bonded ( MBT 0.022 inch prescription), the active distalization or retraction will start when the rectangular stainless steel archwires (0.019" × 0.025"). The end of the treatment will be determined clinically when a class I canine relationship achieved with a good incisor relationship obtained. Dental casts will be used for the quantification of the anteroposterior movement of the anterior teeth and the first molars before the beginning of the treatment and when a class I canine relationship achieved with a good incisor relationship obtained. Cephalograms will be taken 3 times: the first before the beginning treatment for diagnosis purpose, the second: after the completion of leveling and alignment stage, the third: when a class I canine relationship achieved with a good incisor relationship obtained. Smile photographs will be taken in 2 times: the first before the beginning of the treatment, the second: after the treatment ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04814173
Study type Interventional
Source Hama University
Contact
Status Completed
Phase N/A
Start date May 20, 2022
Completion date August 1, 2022

See also
  Status Clinical Trial Phase
Completed NCT02914431 - Personalized Titanium Plates vs CAD/CAM Surgical Splints in Maxillary Repositioning of Orthognathic Surgery N/A
Recruiting NCT05383820 - Effect of Paracetamol and Ketorolac on RANK-L Levels in Patients Starting Orthodontic Treatment Phase 4
Not yet recruiting NCT03794726 - Comparison of Orthodontic Molar Protraction With and Without Adjunctive Surgery N/A
Not yet recruiting NCT03513003 - The Use of a Pacifier to Correct Malocclusions in Young Children N/A
Completed NCT02603289 - One Week Aligner Evaluation
Terminated NCT01210547 - Three-dimensional Assessment of Craniofacial Structures N/A
Completed NCT01463839 - Sleep Disorder and Oral Habits in Children N/A
Recruiting NCT04946201 - Premolar Extractions for Obstructive Sleep Apnea in Children With Overjet
Recruiting NCT04117360 - Orthognathic Speech Pathology: Phonetic Contrasts of Patients With Dental Discrepancies Pre- and Post-Treatment Analyses
Active, not recruiting NCT06291129 - Gingival Health and Malocclusion Among Type 1 Diabetic Children and Adolescents N/A
Recruiting NCT05684510 - Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy N/A
Completed NCT02659813 - Orthodontic Archwire Effectiveness Trial N/A
Completed NCT02427763 - Microbiological and Epithelial Evaluation Related to the Use of Orthodontic Thermoplastic Device Phase 0
Completed NCT02267811 - The Effect of OrthoPulseā„¢ on the Rate of Orthodontic Tooth Movement N/A
Completed NCT01962012 - Effect of AcceleDent® Aura on Orthodontic Tooth Movement With Aligners Phase 4
Completed NCT03405961 - A Comparison of Conventional Versus Digital PAR (Peer Assessment Rating) Scores Using an Intraoral Scanner
Completed NCT05356780 - Predictability of Orthodontic Tooth Movement With Invisalign Aligners
Recruiting NCT06218641 - Discomfort Perceived by a Cohort of Patients Treated With Aligners and Attachments Placed According to Two Different Protocols N/A
Completed NCT05711160 - Comparison of the Accuracy and Reliability of Measurements Made on CBCT and IOS Images With Their made-on Plaster Models.
Recruiting NCT06140043 - Augmented Reality for Orthognatic Surgery Patient Education Phase 2/Phase 3