The Use of a Modified Dentoalveolar Distractor to Retract Maxillary Canines

NCT ID: NCT02332421

Last Updated: 2015-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-09-30

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.

Conditions

Orthodontic Patients Requiring Canine Retraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

modified dentoalveolar distractor

Canine retraction will be accomplished using a modified dentoalveolar distractor

Group Type: EXPERIMENTAL

modified dentoalveolar distractor

Intervention Type: DEVICE

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

conventional dentoalveolar distractor

Canine retraction will be accomplished using a conventional dentoalveolar distractor

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

modified dentoalveolar distractor

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Damascus University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Khaled Alainawi, DDS

Role: PRINCIPAL_INVESTIGATOR

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

Yassir Al-Medallal, DDS MSc PhD

Role: STUDY_DIRECTOR

Associate Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School

Mohammad Y Hajeer, DDS MSc PhD

Role: STUDY_DIRECTOR

Associate Professor of Orthodontics, University of Damascus Dental School

Locations

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

Damascus, Damscus, Syria

Countries

Syria

References

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.

Reference Type: BACKGROUND

PMID: 20050758 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17319756 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16043471 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11928095 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24876710 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24453442 (View on PubMed)

Other Identifiers

UDDS-OMFS-02-2015

Identifier Type: -

Identifier Source: org_study_id