Orthodontic Patients Requiring Canine RetractionNCT02332421
The Use of a Modified Dentoalveolar Distractor to Retract Maxillary Canines
A study testing modified dentoalveolar distractor in people with Orthodontic Patients Requiring Canine Retraction, run by Damascus University at 1 site in Syria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Orthodontic Patients Requiring Canine Retraction
- What is being tested?
- modified dentoalveolar distractor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSyria
- Study dates
- Jun 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Indication for extraction of upper first premolar and conducting canine retraction
- Good oral hygiene
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Oral and Maxillofacial Surgery, University of Damascus Dental School
Damascus, Damscus, DM20AM18
About this study
Official title: 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.
Read the 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.
- Being tested
- modified dentoalveolar distractor
- Keywords
- canine retraction, acceleration of tooth movement, dentoalveolar distraction osteogenesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified dentoalveolar distractorDevice
Here, the modified distractor is going to be used when retracting the canine.
| Study group | Role | What they receive |
|---|---|---|
| modified dentoalveolar distractor | Experimental | Canine retraction will be accomplished using a modified dentoalveolar distractor Receives: Device: modified dentoalveolar distractor |
| conventional dentoalveolar distractor | No intervention | Canine retraction will be accomplished using a conventional dentoalveolar distractor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (3)
Change in Canine Pulp Vitality
This variable is going to be measured clinically
Measured: 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
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startJun 2014
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Orthodontic Patients Requiring Canine RetractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khaled Alainawi, DDS, Principal investigator, MSc student, Oral and Maxillofacial Surgery Department, University of Damascus Dental SchoolYassir Al-Medallal, DDS MSc PhD, Study director, Associate Professor of Oral and Maxillofacial Surgery, University of Damascus Dental SchoolMohammad Y Hajeer, DDS MSc PhD, Study director, Associate Professor of Orthodontics, University of Damascus Dental School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332421
- Sponsor's protocol ID
- UDDS-OMFS-02-2015
- Status last verified
- Jan 2015
- First submitted
- 3 Jan 2015
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 20050758Sukurica 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.
PubMed 17319756Gurgan 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.
PubMed 16043471Kisnisci 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.
PubMed 11928095Nair 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.
PubMed 24876710Kumar 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.
PubMed 24453442
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Of The Short-Term Therapeutic Effects Between Two Distractors Used For The Retraction Of Maxillary Canines By Dentoalveolar Distraction Osteogenesis
- ClinicalTrials.gov ID
- NCT02332421
- Acronym / sponsor ID
- UDDS-OMFS-02-2015
- Keywords
- canine retraction, acceleration of tooth movement, dentoalveolar distraction osteogenesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| modified dentoalveolar distractor | Experimental | Device: modified dentoalveolar distractorCanine retraction will be accomplished using a modified dentoalveolar distractor |
| conventional dentoalveolar distractor | No intervention | –Canine retraction will be accomplished using a conventional dentoalveolar distractor |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Indication for extraction of upper first premolar and conducting canine retraction
- Good oral hygiene
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modified dentoalveolar distractorHere, the modified distractor is going to be used when retracting the canine. | Device | modified dentoalveolar distractor |
Primary outcome
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.
3 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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2015.
- Background: PubMed 20050758Kurt 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.
- Background: PubMed 17319756Sukurica 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.
- Background: PubMed 16043471Gurgan 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.
- Background: PubMed 11928095Kisnisci 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.
- Background: PubMed 24876710Nair 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.
- Background: PubMed 24453442Kumar 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khaled Alainawi, DDS principal investigator
MSc student, Oral and Maxillofacial Surgery Department, University of Damascus Dental School
Yassir Al-Medallal, DDS MSc PhD study director
Associate Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School
Mohammad Y Hajeer, DDS MSc PhD study director
Associate Professor of Orthodontics, University of Damascus Dental School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified dentoalveolar distractor in people with Orthodontic Patients Requiring Canine Retraction, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02332421, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2015.