MalocclusionNCT01654419
Comparison of the Quantity of Distal Movement of the Upper Canine and Molar
A study testing Class II elastics and Sliding Jig and Class II elastic alone in people with Malocclusion, run by Universidad de Antioquia at 1 site in Colombia.
Trial summary
THE PURPOSE OF THE STUDY IS COMPARE THE QUANTITY OF DISTAL MOVEMENT OF THE UPPER CANINE AND MOLAR USING CLASS II ELASTICS WITH AND WITHOUT SLIDING JIG IN A PERIOD OF 3 MONTHS Read more about this study
- Who is it for?
- Ages 13 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion
- What is being tested?
- Class II elastics and Sliding Jig and Class II elastic alone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteColombia
- Study dates
- Mar 2010to May 2012
- 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 13 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Class II dental malocclusion with alignment and leveling phase ended.
- Root completed not trauma
- Second molar erupted
- Third molar absent
- Dental and periodontal health
Who cannot join
- Root uncompleted
- Dental Trauma
- Dental Pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Quantity of Distal Movement of the Upper Canine and Molar Using Class II Elastics With and Without Sliding Jig in a Period of 3 Months
THE PURPOSE OF THE STUDY IS COMPARE THE QUANTITY OF DISTAL MOVEMENT OF THE UPPER CANINE AND MOLAR USING CLASS II ELASTICS WITH AND WITHOUT SLIDING JIG IN A PERIOD OF 3 MONTHS
Read the detailed description
To achieve a Class I canine relationship at the end of the alignment and leveling phase, different intraoral devices have been used. These include intermaxillary class II elastics, which retract the upper and protract the lower arch, generating extrusive forces at the anchorage sites. Its upper distalizing action is exerted to the canine bracket and transmitted through the posterior teeth where the upper molar does not receive a direct force. The sliding jig is an auxiliary addition that exerts force to the molar by an elastic hanged in a jig between the lateral and the canine in class II; such mechanism decreases the vertical adverse effects of the elastics wearing while directing the distalizing force to the molar.
A randomized, unblinded, clinical trial comparing 30 units of analysis (hemi arches) in which were placed sliding jig or stand alone elastics were perform.
- Conditions
- Malocclusion
- Being tested
- Class II elastics and Sliding Jig, Class II elastic alone
- Keywords
- sliding jig, Class II malocclusion, Distalization mechanics, Intermaxillary elastics
- Medical subject headings
- Malocclusion, Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Class II elastics and Sliding JigDevice
Also called Archwire SS 16X22, Sliding Jig made in SS 17X25, Elastics 3/16 Heavy (6oz) Impala (Ormco)
Class II elastics, 3/16 6 oz, used daily for 3 months 24 hours per day and sliding jig orthodontic device
Class II elastic aloneDevice
Also called Elastics 3/16 heavy, 6oz. Impala (Ormco)
Elastics Class II alone, used 24 hours per day for 3 months from the hook of the upper canine to the first lower molar hook
| Study group | Role | What they receive |
|---|---|---|
| Class II elastics alone | Active comparator | Use of class II elastics alone to correct class II dental malocclusions Receives: Device: Class II elastic alone |
| Class II elastics with Sliding Jig | Experimental | Class II elastics with Sliding Jig for correction of dental class II malocclusion Receives: Device: Class II elastics and Sliding Jig |
What is being measured
The primary outcome is the main question the study is designed to answer.
CT analysis for comparison of distal movement of upper canine and molar using class II elastics
CT were taken to compare the quantity of distal movement of the upper canine and molar using class II elastics alone.
Measured: 3 months
Secondary outcomes (1)
CT analysis for comparison of distal movement of upper canine and molar using class II with Sliding Jig
CT were taken to compare the quantity of distal movement of the upper canine and molar using class II elastics with sliding jig
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startMar 2010
- Primary completionOct 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LUIS ALEJANDRO SANCHEZ URIBE, Universidad de Antioquia
- Investigators
- Luis A Sanchez, Professor, Principal investigator, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654419
- Sponsor's protocol ID
- 006-2010
- Status last verified
- Jul 2012
- First submitted
- 12 Jul 2012
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Quantity of Distal Movement of the Upper Canine and Molar Using Class II Elastics With and Without Sliding Jig in a Period of 3 Months
- ClinicalTrials.gov ID
- NCT01654419
- Acronym / sponsor ID
- 006-2010
- Conditions
- Malocclusion
- Keywords
- sliding jig, Class II malocclusion, Distalization mechanics, Intermaxillary elastics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 31 Jul 2012 (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.
THE PURPOSE OF THE STUDY IS COMPARE THE QUANTITY OF DISTAL MOVEMENT OF THE UPPER CANINE AND MOLAR USING CLASS II ELASTICS WITH AND WITHOUT SLIDING JIG IN A PERIOD OF 3 MONTHS
Detailed description
To achieve a Class I canine relationship at the end of the alignment and leveling phase, different intraoral devices have been used. These include intermaxillary class II elastics, which retract the upper and protract the lower arch, generating extrusive forces at the anchorage sites. Its upper distalizing action is exerted to the canine bracket and transmitted through the posterior teeth where the upper molar does not receive a direct force. The sliding jig is an auxiliary addition that exerts force to the molar by an elastic hanged in a jig between the lateral and the canine in class II; such mechanism decreases the vertical adverse effects of the elastics wearing while directing the distalizing force to the molar.
A randomized, unblinded, clinical trial comparing 30 units of analysis (hemi arches) in which were placed sliding jig or stand alone elastics were perform.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Class II elastics alone | Active comparator | Device: Class II elastic aloneUse of class II elastics alone to correct class II dental malocclusions |
| Class II elastics with Sliding Jig | Experimental | Device: Class II elastics and Sliding JigClass II elastics with Sliding Jig for correction of dental class II malocclusion |
Who may qualify
- Ages
- 13 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Class II dental malocclusion with alignment and leveling phase ended.
- Root completed not trauma
- Second molar erupted
- Third molar absent
- Dental and periodontal health
Key exclusion criteria (3 listed)
- Root uncompleted
- Dental Trauma
- Dental Pathology
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 |
|---|---|---|
| Class II elastics and Sliding JigAlso: Archwire SS 16X22, Sliding Jig made in SS 17X25, Elastics 3/16 Heavy (6oz) Impala (Ormco)Class II elastics, 3/16 6 oz, used daily for 3 months 24 hours per day and sliding jig orthodontic device | Device | Class II elastics with Sliding Jig |
| Class II elastic aloneAlso: Elastics 3/16 heavy, 6oz. Impala (Ormco)Elastics Class II alone, used 24 hours per day for 3 months from the hook of the upper canine to the first lower molar hook | Device | Class II elastics alone |
Primary outcome
CT analysis for comparison of distal movement of upper canine and molar using class II elastics
Time frame: 3 months
CT were taken to compare the quantity of distal movement of the upper canine and molar using class II elastics alone.
1 secondary outcome
CT analysis for comparison of distal movement of upper canine and molar using class II with Sliding Jig
Time frame: 3 months
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 31 Jul 2012.
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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.
Luis A Sanchez, Professor principal investigator
Universidad de Antioquia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Class II elastics and Sliding Jig and Class II elastic alone in people with Malocclusion, run by Universidad de Antioquia at 1 site in Colombia.
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 5 inclusion and 3 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 31 Jul 2012. 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 Colombia. 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?
CT analysis for comparison of distal movement of upper canine and molar using class II elastics (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2012.