Ain Shams University
Cairo, El-Abasaya, 7154411, Egypt
NCT Number: NCT06232928
This clinical trial aimed to compare the effect of immediate light short Class II elastics versus conventional Class II elastics on the skeletal, dental and soft tissues in patients with Class II malocclusion.
Participants with class II malocclusion divided into 2 groups; early group wore immediate light short Class II elastics and conventional group wore conventional Class II elastics on rigid stainless steel arch wires.
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Notify Me12 year and older
All sexes
Interventional
Not applicable
Cairo, El-Abasaya, 7154411, Egypt
Instrument and procedures I. Diagnostic Procedures
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I. Diagnostic Procedures Detailed and comprehensive patient diagnosis was performed guided by the evaluation sheet used at the Department of Orthodontics, Faculty of Dentistry, Ain Shams University.
The diagnostic procedure included the following steps:
Smile examination Comprehensive smile analysis was carried out including gingival display on smiling, smile arc, smile symmetry and width of buccal corridors. All the patients included in the study showed normal gingival display on smiling.
Profile examination Examination of facial profile type, lip protrusion and nasolabial angle, lip competence and vertical facial proportions was carried on profile examination.
b. Intraoral examination Full and detailed intraoral examination included number of teeth present in the oral cavity, oral hygiene, periodontal condition of all teeth, the presence of any caries, broken restorations, and missing teeth.
Examining the malocclusion in all planes of space was performed as well. Molar relationship, canine relationships and overjet were determined. The overbite was assessed. The midlines were checked for any shift, and the posterior occlusion was checked to determine any presence of posterior crossbite. Arch form, palatal vault shape and depth were also clinically examined. Patients included into the study showed Class II canine relationship, increased overjet and proclined maxillary incisors.
The functional occlusion was also examined, including discrepancy between the intercuspal position and the retruded contact position, the occlusion during lateral excursions was examined for working and non-working side contacts, and the occlusal guidance was checked during anterior excursions.
c. Functional examination The breathing pattern of each patient was checked. Additionally, the tongue was examined to determine any abnormal posture or function. Mouth breathing patients were referred for consultation to check for patency of airway and remove any causes of respiratory obstruction prior to treatment.
A full set of orthodontic records was taken for every patient as part of the routine procedure for the treatment of patients in the outpatient clinic of the Orthodontic Department, Ain Shams University, including:
a. Photographs
To standardize the camera position in space (horizontal and vertical axes), the camera was connected to the quick-releasing plate which mounts the camera on the tripod. The tripod had two spirit levels which were used to ensure that the mounted camera was not tilted in the horizontal or the vertical axes. The round spirit level was used to adjust the vertical axis of the camera. The horizontal spirit level was used to adjust the horizontal tilt of the camera. This was confirmed by ensuring that the air bubble was in the middle mark of the spirit level for every photo. The vertical level of the camera was raised till the focal point of the lens was at the same level of the patient's nasal tip.
ii. Lens The focal length was set at 55 for all the photos. iii. Patient head orientation A fixed graduated gray background was placed behind the patients at a fixed distance from the patient and the camera was mounted on the tripod.
Also, the graduated background was placed behind the patients. During the photography grids on the camera screen matched with grids of the graduated background. Once the patient sat on the chair. The patient's face mid-sagittal plane was parallel to lines drawn on the background and perpendicular to the floor. Finally, Patients were instructed to smile then the three photographs were taken. The choice of the post- elastics smiles photos was based on the selection of photos with equal lip elevation.
b. Orthodontic study models Alginate impressions were taken for the upper and lower arches of each patient using suitable-sized perforated trays and alginate impression material mixed according to the manufacturer's instructions . Each impression was poured with improved orthodontic stone material . Orthodontic bases were established and trimmed for the study models. Then all models were scanned by a 3-shape R-750 scanner.
c. Orthodontic Radiographic records
Patients were then randomly allocated into the early or conventional groups and after having signed the informed consent, intervention procedures were then started.
II. Interventions
The procedures completed in this study were as follows:
Early group
In the early group, the pre-adjusted edgewise appliance was placed on both maxillary and mandibular arches either in the same visit or at least within the same week. Alignment and leveling were done using a standardized wire sequence. Immediate light short elastics were inserted from the first visit. The details are as follows:
Elastic was placed on the lower second premolar hook and stretched to the upper canine hook by force gauge while the patient occluded then the force level was checked if it was within the light force range (2-3.5 ounces) it would be selected.
Patients were instructed on placement of the elastics using the elastic holder.
Patients were followed up until the achievement of a Class I canine relationship and reaching to 0.016×0.022-inch arch wire stainless steel. Finally, the post-elastics records were taken as follows:
orthodontic study casts. standardized smile and intraoral photographs. cephalometric radiograph. All patients were instructed to wear settling elastics with Class II vector until finishing and removal of fixed appliance.
Conventional group
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants were treated by a fixed orthodontic appliance with intermaxillary class II elastics to correct the class II malocclusion. patients were instructed to wear immediate light short Class II elastics from upper canines to lower second premolars for 24 hours except while eating and change the elastics every 12 hours.
patients were treated by a fixed orthodontic appliance with intermaxillary Class II elastics. patients were instructed to wear Class II elastics from upper canines to lower first molars for 24 hours except while eating and change the elastics every 12 hours after reaching to rigid stainless steel arch wires.
Time frame: from the beginning of the treatment till treatment was done about 15 months
The primary outcome of this study was to compare the effect of early light short elastics versus conventional elastics on the inclination of upper incisors in patients with canine Class II malocclusion.
the Sella-Nasion angle was measured " cephalometric radiographic analysis" in degrees.
the angle representing the maxillary incisors inclination "S-N angle" was measured before and after treatment by both protocols, then the amount of changes were compared.
Time frame: from the beginning of the treatment till treatment was done about 15 months
Time frame: from the beginning of the treatment till treatment was done about 15 months
the standardized smile photos were taken before and after treatment and "linear measurements representing the amount of gingival displays" in mm were done and the changes in gingival display were assessed and comparison between both groups was done.
Time frame: from the beginning of the treatment till treatment was done about 15 months
The assessment of treatment duration for both protocols was done. the number of total months were utilized to treat this malocclusion
Ain Shams University
Other
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