Teeth; Anomaly, Position Clinical Trial
Official title:
A Clinical Comparison of the Effectiveness of Two Types of Orthodontic Aligning Archwire Materials: A Randomized Clinical Trial
| Verified date | September 2019 |
| Source | University of Baghdad |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The aim of this study is to compare the effectiveness of using heat-activated NiTi with
superelastic NiTi archwires during the initial phase of orthodontic treatment.
Primary Objective:
To compare the difference in the amount of crowding in the lower incisors after 4 and 8 weeks
from the start of treatment.
Secondary Objectives:
1. To compare the amount of orthodontically-induced inflammatory root resorption (OIIRR) in
the apical region of mandibular central incisors between the two groups of archwires
2. To compare the amount of pain perception between the two groups of archwires during the
1st week after each wire placement.
| Status | Completed |
| Enrollment | 31 |
| Est. completion date | September 9, 2019 |
| Est. primary completion date | April 26, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 12 Years and older |
| Eligibility |
Inclusion Criteria: 1. Patients indicated for fixed appliance orthodontic treatment who have a moderate crowding (3-6mm) according to the Little's irregularity index (LII). 2. Full set of lower permanent dentition excluding the third molars. 3. No history of trauma or root resorption in the lower incisors. Exclusion Criteria: 1. Previous orthodontic treatment. 2. Less than 3mm of lower incisor crowding (LII) or with spaced incisors. 3. Severe crowding in the lower arch (greater than 7mm) which requires extraction. 4. Blocked-out teeth that cannot be engaged with the aligning archwire. 5. Patients with periodontally compromised teeth. |
| Country | Name | City | State |
|---|---|---|---|
| Iraq | Yassir A. Yassir | Baghdad |
| Lead Sponsor | Collaborator |
|---|---|
| University of Baghdad |
Iraq,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Primary outcome (Alignment efficiency) | The study models, which should be free from any inconsistency (such as bubbles), were used to measure the Little's irregularity index (Little, 1975). This was calculated using a digital Vernier caliper to measure the extent of mesial and distal contact displacement from the mesial contact point of lower canine to that on the other side (to the nearest 0.01mm). | 2 months | |
| Secondary | Root resorption | Root resorption was evaluated pre-treatment and after 8 weeks using periapical X-ray with digital X-ray sensors (ATECO). Radiographic films were positioned using a customized sensor holder for the lower anterior teeth with a 7cm film-cone distance using long cone paralleling technique. The radiographs were made at 70kV and 8mA DC with an exposure of 0.25 seconds. | 2 months | |
| Secondary | Pain perception | Evaluations of pain/discomfort was made in the evening on a daily basis over the first 7 days after bonding using a 10-point visual analog scale (VAS) of 10cm length. The highest pain level experienced should be reported by each patient. The recording sheet was received by all the patients on the day of bonding, it included seven visual analog scales (one for each day) and the patients were given oral instructions on how to finish the VAS by marking the point on the line which supposed to represent the maximum pain that they felt per day, with 0 refers to "no pain" and 10 refers to "intolerable pain". Patients were reminded daily by a phone call or a text message to mark the recording sheet and to bring it on their next appointment. | 2 months |