Department of Orthodontics , DIEKIOHS, Dow University Of Health Sciences, Ojha Campus.
Karachi, Sindh, Pakistan
Completed
NCT Number: NCT04184427
Effects on Maxillary Anterior Dentition Following En Masse Retraction Using Mini-implants and Various Heights of Anterior Power Arm.
The controlled three dimensional movement of anterior dentition during orthodontic treatment is a desire of every orthodontist. Maxillary en masse retraction with mini implants has been reported to provide absolute anchorage thus utilizing the complete extraction spaces thereby enhancing patient's esthetics. Power arm or anterior retraction hook permits the application of force close to a desired direction thereby warranting better anterior dentition control. Various heights of power arms and proposed centre of resistance for six maxillary anterior teeth have been estimated through finite element model and also from a very limited number of clinical studies. For a set of teeth, the determination of centre of resistance is complex in actual clinical scenario and response of force applied from certain level for better anterior dentition control requires sufficient clinical evidence suggestive of further clinical studies to endow orthodontists to hasten treatment due to less time consumption during finishing stage of orthodontic treatment.
Completed
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Notify MeKey information
Age range
18 year–30 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
This Randomized Control Trial will be conducted to compare the effects of various heights of anterior power arm on maxillary anterior dentition following en masse retraction with mini-implants by participation of thirty patients meeting eligibility criteria. The participants will be divided in three groups through software generated randomization table. Group I (control group; height of anterior power arm 6 mm), Group II and Group III (experimental groups; height of anterior power arm 3 mm and 9 mm, respectively). Ten patients will be allocated in each group. En masse retraction with mini implants and various heights of anterior power arm will be carried out immediately after bilateral maxillary first premolar extractions using continuous arch sliding mechanics. Horizontal, vertical and angular dimensions will be measured on lateral cephalograms while the transverse effects will be measured on maxillary dental cast. Both lateral cephalograms and dental casts will be obtained at two different point of time; T1, before retraction and T2, after complete extraction space closure. The data will be assessed with-in and among groups.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients between ages 18-30 years.
- Good oral hygiene and healthy periodontal tissues.
- Patients having overjet ≥ 7 mm and ≤ 10 mm and overbite of 2-3 mm.
- Pt with molar relation angle's full cusp Class II requiring symmetric extractions of maxillary 1st premolars and maximum anchorage.
- Patients having coincident maxillary midline with the facial midline.
Exclusion criteria
- Patients with maxillary anterior teeth have dilacerations, fusion, hyper-cementosis, shorter roots or any other tooth anomaly.
- Patients with traumatized or impacted teeth in the anterior maxilla.
- Patients with moderate to severe crowding in maxillary and mandibular arch.
- History of bone metabolic disorders or patients receiving drugs that alter bone metabolism.
- History of systemic diseases or hormonal imbalance that hinders orthodontic tooth movement.
Treatment and study plan
Anterior Power Arm
OtherCrimpable stainless steel hook placed on orthodontic base arch wire.
Other names: Anterior Retraction Hook
Primary outcomes
-
Change in maxillary central incisor sagittal dimension
Time frame: Upto 1 year
IoSV (mm), IaSV (mm), IaSV/IoSV
-
Change in maxillary central incisor vertical dimension
Time frame: Upto 1 year
IoPP (mm), IaPP (mm)
-
Change in maxillary central incisor angular dimension
Time frame: Upto 1 year
I-angle (degrees)
-
Change in maxillary anterior transverse dimension
Time frame: Upto 1 year
Intercanine width (mm)
Sponsors and collaborators
Lead sponsor
Dow University of Health Sciences
Other
Registry information
Official study title
Effects On Maxillary Anterior Dentition Following En- Masse Retraction Using Mini-Implants and Various Heights of Anterior Power Arm- A Randomized Controlled Trial
Important dates
- Study start
- 2019
- Primary completion
- 2021
- Study completion
- 2021
- First posted
- Dec 3, 2019
- Registry last updated
- Oct 25, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.