The Use of a Modified Dentoalveolar Distractor to Retract Maxillary Canines

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

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.

Study Overview

• Status: Completed
• Conditions: Orthodontic Patients Requiring Canine Retraction
• Intervention / Treatment: Device: modified dentoalveolar distractor

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Damscus
    • Damascus, Damscus, Syrian Arab Republic, DM20AM18
      • Department of Oral and Maxillofacial Surgery, University of Damascus Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: modified dentoalveolar distractor; Canine retraction will be accomplished using a modified dentoalveolar distractor	Device: modified dentoalveolar distractor; Here, the modified distractor is going to be used when retracting the canine.
No Intervention: conventional dentoalveolar distractor; Canine retraction will be accomplished using a conventional dentoalveolar distractor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the mesiodistal inclination of the canine	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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Canine Pulp Vitality	This variable is going to be measured clinically	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.
Molars Anchorage Loss	This will be measured using cephalograms and study models	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.
Patient acceptance to each distractor	Using a visual analog scale.	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.

Collaborators and Investigators

• Sponsor: Damascus University
• Investigators: Principal Investigator: Khaled Alainawi, DDS, MSc student, Oral and Maxillofacial Surgery Department, University of Damascus Dental School; Study Director: Yassir Al-Medallal, DDS MSc PhD, Associate Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School

Publications and helpful links

General Publications

• Kurt G, Iseri H, Kisnisci R. Rapid tooth movement and orthodontic treatment using dentoalveolar distraction (DAD). Long-term (5 years) follow-up of a Class II case. Angle Orthod. 2010 May;80(3):597-606. doi: 10.2319/041209-209.1.
• Sukurica Y, Karaman A, Gurel HG, Dolanmaz D. Rapid canine distalization through segmental alveolar distraction osteogenesis. Angle Orthod. 2007 Mar;77(2):226-36. doi: 10.2319/0003-3219(2007)077[0226:RCDTSA]2.0.CO;2.
• Gurgan CA, Iseri H, Kisnisci R. Alterations in gingival dimensions following rapid canine retraction using dentoalveolar distraction osteogenesis. Eur J Orthod. 2005 Aug;27(4):324-32. doi: 10.1093/ejo/cji011.
• Kisnisci RS, Iseri H, Tuz HH, Altug AT. Dentoalveolar distraction osteogenesis for rapid orthodontic canine retraction. J Oral Maxillofac Surg. 2002 Apr;60(4):389-94. doi: 10.1053/joms.2002.31226.
• Nair A, Kumar JP, Venkataramana V, Yuvaraj A, Reddy VS, Kumar SK. Dento-Alveolar distraction osteogenesis using rigid intra-oral tooth borne distraction device. J Int Oral Health. 2014 Apr;6(2):106-13. Epub 2014 Apr 26.
• Kumar N, Prashantha G, Raikar S, Ranganath K, Mathew S, Nambiar S. Dento-Alveolar Distraction Osteogenesis for rapid Orthodontic Canine Retraction. J Int Oral Health. 2013 Dec;5(6):31-41. Epub 2013 Dec 26.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: January 3, 2015
• First Submitted That Met QC Criteria: January 5, 2015
• First Posted (Estimate): January 6, 2015

Study Record Updates

• Last Update Posted (Estimate): September 29, 2015
• Last Update Submitted That Met QC Criteria: September 26, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: canine retraction; acceleration of tooth movement; dentoalveolar distraction osteogenesis
• Other Study ID Numbers: UDDS-OMFS-02-2015