Conditions in T74.31 or T76.31Phase 2/3NCT01473745
The Nasal Changes Affected by Different Alar Base Suture Techniques After Maxillary LeFort I Osteotomy
A Phase 2/3 study testing conventional alar base cinch and modified alar base cinch in people with Conditions in T74.31 or T76.31, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
study hypothesis 1. The aim of this study: How can the investigators predict and control the nasal changes after maxillary LeFort I osteotomy with 2 different alar base suture techniques ? 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Conditions in T74.31 or T76.31
- What is being tested?
- conventional alar base cinch and modified alar base cinch
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2011to Jan 2014
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Taiwanese patients who received LeFort I osteotomy at CGMH during 2011-2012
- No previous craniofacial surgery
- Patients agreed to attend this study and willing to sign the agreement
- Patients who are elder than 18 years old and after growth completion
Who cannot join
- Craniofacial anomalies
- cleft lip and /or palate patients
- patients without all the documents
- patients do not receive combined correcting nasolabial shape and orthognathic surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Nasal Changes Affected by 2 Different Alar Base Suture Techniques After Maxillary LeFort I Osteotomy--A Randomized Controlled Trial
study hypothesis
- The aim of this study: How can the investigators predict and control the nasal changes after maxillary LeFort I osteotomy with 2 different alar base suture techniques ?
- Study hypothesis
- Null hypothesis: Nasal changes were not affected by 2 different alar base suture techniques after maxillary LeFort I osteotomy
- Alternative : Nasal changes were affected by 2 different alar base suture techniques after maxillary LeFort I osteotomy
Read the detailed description
Background and study purpose:
Patients who received maxillary LeFort I osteotomy often complained about their nose become wider and more nostril show after surgery. According the the literature review, the conventional and modified alar base cinch technique both could control the interalar width. However, there is no long term result show which technique is superior to the other. Therefore, in order to improve patients' nasal and midfacial esthetics after the surgery, this study is to evaluate how the nasal changes affected by 2 different alar base cinch suture and which technique could result in a more positive effect.
- Conditions
- Conditions in T74.31 or T76.31
- Being tested
- conventional alar base cinch, modified alar base cinch
- Keywords
- Alar Base Suture; Nasolabial Change; 3D stereogrammetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional alar base cinchProcedure or surgery
Also called conventional alar cinch suture technique
The conventional suture began from the bilateral alar part of the nasalis muscle and passed through a hole drilled on the anterior nasal spine.
modified alar base cinchProcedure or surgery
Also called modified alar base cinch technique
The modified suture began from the bilateral alar part of the nasalis muscle and dermis tissue over the alar base, and then passed through a hole drilled on the anterior nasal spine.
| Study group | Role | What they receive |
|---|---|---|
| modified alar base cinch suture | Active comparator | Before closure of the maxillary wound, an alar base cinch suture was performed with 3-O Nylon. The modified alar cinch suture began from the bilateral alar part of the nasalis muscle and dermis tissue over the alar base, and then passed through a hole drilled on the anterior nasal spine. Receives: Procedure: modified alar base cinch |
| conventional alar base cinch suture | Placebo comparator | Before closure of the maxillary wound, an alar base cinch suture was performed with 3-O Nylon. The conventional alar base cinch suture began from the bilateral alar part of the nasalis muscle and passed through a hole drilled on the anterior nasal spine. Receives: Procedure: conventional alar base cinch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft and Hard Tissue Landmarks Movement
The investigator measured the movement (1 month minus baseline) of hard tissue landmarks before and after 4-6 weeks maxillary LeFort I osteotomy. The movement (6 months minus baseline) of soft tissue landmarks was measured before and after 6 months of the maxillary LeFort I osteotomy.
The 3D directional movement of each point was measured in the x(transverse), y(vertical), and z (antero-posterior)planes. The positive directional movement of each point in X axis means the point moved left after surgery, and negative directional movement in X axis means the the point moved right after surgery. The positive directional movement in Y axis means the point moved upward after surgery, and negative directional movement in Y axis means the the point moved downward after surgery. The positive directional movement in Z axis means the point moved anteriorly after surgery, and negative directional movement in Z axis means the the point moved posteriorly after surgery.
Measured: The hard tissue movements were assessed after surgery 4-6 weeks.The soft tissue movements were assessed after surgery 6 months.
Secondary outcomes (2)
14 Nasolabial Linear Parameters
- baseline characteristics: intercanthulus distance
- nasal linear parameters
- nasolabial linear parameters
Measured: up to post-operation 6 months
1 Nasolabial Angular Parameters
2D nasolabial angular parameter: Nasolabial angle (NLA) (The NLA was a two dimensional measurement and was measured at the midsagittal plane with Image J software®)
Measured: up to post-operation 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Conditions in T74.31 or T76.31Studies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellen, Wen Ching Ko, DDS,MS, Study director, Chang Gung MHYiHsuan Chen, DDS, MS, Principal investigator, Chang Gung MH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473745
- Sponsor's protocol ID
- CGMH-100-1653A3
- Other IDs
- ChangGungMH
- Status last verified
- Aug 2011
- First submitted
- 15 Nov 2011
- Last updated
- 4 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Nasal Changes Affected by 2 Different Alar Base Suture Techniques After Maxillary LeFort I Osteotomy--A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01473745
- Acronym / sponsor ID
- CGMH-100-1653A3
- Conditions
- Conditions in T74.31 or T76.31
- Keywords
- Alar Base Suture; Nasolabial Change; 3D stereogrammetry
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 17 Nov 2011 (estimated)
- Results
- Posted 8 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
study hypothesis
- The aim of this study: How can the investigators predict and control the nasal changes after maxillary LeFort I osteotomy with 2 different alar base suture techniques ?
- Study hypothesis
- Null hypothesis: Nasal changes were not affected by 2 different alar base suture techniques after maxillary LeFort I osteotomy
- Alternative : Nasal changes were affected by 2 different alar base suture techniques after maxillary LeFort I osteotomy
Detailed description
Background and study purpose:
Patients who received maxillary LeFort I osteotomy often complained about their nose become wider and more nostril show after surgery. According the the literature review, the conventional and modified alar base cinch technique both could control the interalar width. However, there is no long term result show which technique is superior to the other. Therefore, in order to improve patients' nasal and midfacial esthetics after the surgery, this study is to evaluate how the nasal changes affected by 2 different alar base cinch suture and which technique could result in a more positive effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| modified alar base cinch suture | Active comparator | Procedure: modified alar base cinchBefore closure of the maxillary wound, an alar base cinch suture was performed with 3-O Nylon. The modified alar cinch suture began from the bilateral alar part of the nasalis muscle and dermis tissue over the alar base, and then passed through a hole drilled on the anterior nasal spine. |
| conventional alar base cinch suture | Placebo comparator | Procedure: conventional alar base cinchBefore closure of the maxillary wound, an alar base cinch suture was performed with 3-O Nylon. The conventional alar base cinch suture began from the bilateral alar part of the nasalis muscle and passed through a hole drilled on the anterior nasal spine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Taiwanese patients who received LeFort I osteotomy at CGMH during 2011-2012
- No previous craniofacial surgery
- Patients agreed to attend this study and willing to sign the agreement
- Patients who are elder than 18 years old and after growth completion
Key exclusion criteria (4 listed)
- Craniofacial anomalies
- cleft lip and /or palate patients
- patients without all the documents
- patients do not receive combined correcting nasolabial shape and orthognathic surgery.
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 |
|---|---|---|
| conventional alar base cinchAlso: conventional alar cinch suture techniqueThe conventional suture began from the bilateral alar part of the nasalis muscle and passed through a hole drilled on the anterior nasal spine. | Procedure or surgery | conventional alar base cinch suture |
| modified alar base cinchAlso: modified alar base cinch techniqueThe modified suture began from the bilateral alar part of the nasalis muscle and dermis tissue over the alar base, and then passed through a hole drilled on the anterior nasal spine. | Procedure or surgery | modified alar base cinch suture |
Primary outcome
Soft and Hard Tissue Landmarks Movement
Time frame: The hard tissue movements were assessed after surgery 4-6 weeks.The soft tissue movements were assessed after surgery 6 months.
The investigator measured the movement (1 month minus baseline) of hard tissue landmarks before and after 4-6 weeks maxillary LeFort I osteotomy. The movement (6 months minus baseline) of soft tissue landmarks was measured before and after 6 months of the maxillary LeFort I osteotomy. The 3D directional movement of each point was measured in the x(transverse), y(vertical), and z (antero-posterior)planes. The positive directional movement of each point in X axis means the point moved left after surgery, and negative directional movement in X axis means the the point moved right after surgery. The positive directional movement in Y axis means the point moved upward after surgery, and negative directional movement in Y axis means the the point moved downward after surgery. The positive directional movement in Z axis means the point moved anteriorly after surgery, and negative directional movement in Z axis means the the point moved posteriorly after surgery.
2 secondary outcomes
14 Nasolabial Linear Parameters
Time frame: up to post-operation 6 months
1 Nasolabial Angular Parameters
Time frame: up to post-operation 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Ellen, Wen Ching Ko, DDS,MS study director
Chang Gung MH
YiHsuan Chen, DDS, MS principal investigator
Chang Gung MH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing conventional alar base cinch and modified alar base cinch in people with Conditions in T74.31 or T76.31, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 4 inclusion and 4 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 4 Nov 2014. 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 Taiwan. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Soft and Hard Tissue Landmarks Movement (time frame: The hard tissue movements were assessed after surgery 4-6 weeks.The soft tissue movements were assessed after surgery 6 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 4 Nov 2014.