Completed

NCT Number: NCT02332421

The Use of a Modified Dentoalveolar Distractor to Retract Maxillary Canines

In this study, two distractors will be used to retract maxillary canines into the extraction sites. The first distractor is a modified Hyrax expander with two arms soldered to two bands connected to a canine and a molar; and the second one is a similar to the first one but with the addition of a third arm.

The purpose of this investigation is to compare the two distractors in terms of: final position of the canine, canine pulp vitality, molars' anchorage, patient's acceptance to the appliance.

Completed

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Key information

Conditions

Orthodontic Patients Requiring Canine Retraction

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Oral and Maxillofacial Surgery, University of Damascus Dental School

Damascus, Damscus, DM20AM18, Syria

About this study

The retraction of the canines is one of the longest and most important stages in the orthodontic treatment of cases that require premolars extraction. The retraction phase of the canines into an extraction site with conventional treatment method usually lasts about 4 to 6 months under normal circumstances. The use of dentoalveolar distraction (DAD) technique has been considered a very important step in this field. It has been shown by early case reports that this technique can be employed to retract canines within 10 to 14 days.

Although DAD is thought to accelerate tooth movement during canine retraction, a significant amount of tipping (distal tilting) was observed in many case reports. So in this study, there is an intention to apply a modified DAD device on one side of the mouth and to compare it with the conventional one applied on the opposite side of the mouth in each participating patient.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Indication for extraction of upper first premolar and conducting canine retraction
Good oral hygiene

Exclusion criteria

Buccal or palatal inclination of the canines
Mesial or distal inclination of the canines
Contraindication to minor surgery
Previous orthodontic or surgical treatment
Root canal treatment to the canines
Malformation of the canines

Treatment and study plan

modified dentoalveolar distractor

Device

Here, the modified distractor is going to be used when retracting the canine.

Primary outcomes

Change in the mesiodistal inclination of the canine

Time frame: This will be measured at three times: T0, one day before installing the distractor; T1, in the same day of finishing the retraction phase; T2, in the same day of device removal from the mouth.

This will be measured using a lateral cephalogram taken at these assessment times. The long axis of the canine will be drawn on the tracing of the cephalogram at each assessment time and this long axis will be measured with reference to anterior cranial base.

Secondary outcomes

Change in Canine Pulp Vitality

Time frame: This will be measured at three times: T0, one day before installing the distractor; T1, in the same day of finishing the retraction phase; T2, in the same day of device removal from the mouth.

This variable is going to be measured clinically
Molars Anchorage Loss

Time frame: Upper first molar position will be measured at three assessment times: T0, one day before installing the distractor; T1, in the same day of finishing the retraction phase; T2, in the same day of device removal from the mouth.

This will be measured using cephalograms and study models
Patient acceptance to each distractor

Time frame: This is going to be measured at: (T1) first day following surgery, (T2) five days following surgery, (T3) two weeks following surgery, and (T4) at the time of appliance removal.

Using a visual analog scale.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

A Comparison Of The Short-Term Therapeutic Effects Between Two Distractors Used For The Retraction Of Maxillary Canines By Dentoalveolar Distraction Osteogenesis

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Jan 6, 2015
Registry last updated: Sep 29, 2015

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.