Clinical trial NCT02332421: The Use of a Modified Dentoalveolar Distractor to Retract Maxillary Canines
Official title: A Comparison Of The Short-Term Therapeutic Effects Between Two Distractors Used For The Retraction Of Maxillary Canines By Dentoalveolar Distraction Osteogenesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontic Patients Requiring Canine Retraction
Keywords: canine retraction
acceleration of tooth movement
dentoalveolar distraction osteogenesis
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2015-01-06
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the mesiodistal inclination of the canine
timeFrame: 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 outcomes:
measure: Change in Canine Pulp Vitality
timeFrame: 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.
measure: Molars Anchorage Loss
timeFrame: 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.
measure: Patient acceptance to each distractor
timeFrame: 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.
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Oral and Maxillofacial Surgery, University of Damascus Dental School
state: Damscus
Study officials:
affiliation: MSc student, Oral and Maxillofacial Surgery Department, University of Damascus Dental School
name: Khaled Alainawi, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School
name: Yassir Al-Medallal, DDS MSc PhD
role: STUDY_DIRECTOR
affiliation: Associate Professor of Orthodontics, University of Damascus Dental School
name: Mohammad Y Hajeer, DDS MSc PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.