Cleft Lip and PalateNCT01871623
One-Piece Le Fort I Osteotomy Versus Segmental Le Fort I Osteotomy
A study testing Segmental Le Fort I osteotomy and One-piece Le Fort I Osteotomy in people with Cleft Lip and Palate and Le Fort, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Le Fort I osteotomy is often used in orthognathic surgery for patients to solve midface retrusion. It is known that post-surgical stability of Le Fort I osteotomy can be influenced by single jaw or bimaxillary procedures, fixation techniques or interpositional grafting. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cleft Lip and Palate, Le Fort
- What is being tested?
- Segmental Le Fort I osteotomy and One-piece Le Fort I Osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2013to Dec 2016
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cleft lip/palate patients
- Non growing Taiwanese adults, at least 18 years old for men and 16 years old for women
- Patients with midface retrusion and malocclusion that will need Le Fort I osteotomy
- Rigid fixation with bone plates
- Patients who signs the informed consent form
Who cannot join
- Association with craniofacial anomalies
- Patient without complete 3D imaging records including CBCT scans and digital dental models
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Craniofacial Center
Taipei / Taoyuan
About this study
Official title: Stability of One-Piece Le Fort I Osteotomy Versus Segmental Le Fort I Osteotomy: A Prospective Study
Le Fort I osteotomy is often used in orthognathic surgery for patients to solve midface retrusion. It is known that post-surgical stability of Le Fort I osteotomy can be influenced by single jaw or bimaxillary procedures, fixation techniques or interpositional grafting. In patients with cleft lip and palate, the postoperative instability of Le Fort I osteotomy can be even worse due to scar tissue resulted from palate surgery. Segmental LeFort I osteotomy is another useful surgical modifications that can be easily done through the alveolar cleft. It is performed to allow the correction of differences in the occlusal planes, correction of transverse discrepancy or to facilitate an optimal occlusion. The most important benefits is that the alveolar cleft in patients who have not had alveolar bone graft surgery or failed to have successful result can be narrow down or even closed by approximation of two separating alveolar segments. However, there are limited previous studies comparing the stability of segmental versus one-piece Le Fort I osteotomy especially in patients with cleft. It is our aim to investigate whether one-piece Le Fort I osteotomy or segmental Le Fort I osteotomy can provide a better stability after surgery.
Read the detailed description
Measurements Skeletal movement
- Skeletal Surgical movement from T2 to T1
- positional change of landmarks in vertical from constructed Frankfurt plane
- positional change of landmarks in horizontal plane in relative to constructed coronal plane through Sella point
- Post-Surgical skeletal movement (Stability) from T3 to T2
- positional change of landmarks in vertical from constructed Frankfurt plane
- positional change of landmarks in horizontal plane in relative to constructed coronal plane through Sella point
- Skeletal angular measurement change on mid-sagittal plane from (T2 to T1) and (T3 to T2)
- Dental change measured from digital maxillary cast in transverse direction from (T2 to T1) and (T3 to T2)
- Facial Height / Facial Proportion changes from (T2 to T1) and (T3 to T2)
- Alveolar cleft width changes from (T2 to T1) and (T3 to T2)
- Conditions
- Cleft Lip and Palate, Le Fort
- Being tested
- Segmental Le Fort I osteotomy, One-piece Le Fort I Osteotomy
- Keywords
- Cleft lip and palate, Cone-Beam Computed Tomography, Le Fort I Osteotomy, Segmental Osteotomy, Stability
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Segmental Le Fort I osteotomyProcedure or surgery
Also called Segmental maxillary osteotomy, Maxillary Segmental osteotomy
comparison the stability of segmental Le Fort I osteotomy with conventional approach of one-piece Le Fort I osteotomy
One-piece Le Fort I OsteotomyProcedure or surgery
Also called Le Fort I Osteotomy, Le Fort 1 Osteotomy
conventional approach
| Study group | Role | What they receive |
|---|---|---|
| Segmental Le Fort I Osteotomy | Experimental | For some cases that bone filling over cleft site is not good enough for tooth movement, it is possible that we put them into this group which means by using Segmental Le Fort I Osteotomy to approximate two dental alveolar segments. Receives: Procedure: Segmental Le Fort I osteotomy |
| One-piece Le Fort I Osteotomy | Active comparator | For patients having ideal bone graft result over cleft site, traditional One-piece Le Fort I Osteotomy will be performed. Receives: Procedure: One-piece Le Fort I Osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
stability and relapse rate of surgical movement
to compare the stability and relapse rate in vertical, horizontal and transverse among two kinds of different surgical techniuques
Measured: 6 months after surgery & 1-2 years till the completion of the treatment
Secondary outcomes (1)
Presence of pathological change of cleft-adjacent teeth
record any periodontal breakdown or periapical radiolucency of cleft-adjacent teeth
Measured: immediate after surgery, 6 months after surgery & 2 years till the completion of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startApr 2013
- Primary completionMar 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip and PalateStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu Fang Liao, Ph.D., Study director, Chang Gung Craniofacial Center , Chang Gung Memorial Hospial , Taoyuan , Taiwa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01871623
- Sponsor's protocol ID
- 101-4416A3
- Status last verified
- Mar 2013
- First submitted
- 23 May 2013
- Last updated
- 7 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stability of One-Piece Le Fort I Osteotomy Versus Segmental Le Fort I Osteotomy: A Prospective Study
- ClinicalTrials.gov ID
- NCT01871623
- Acronym / sponsor ID
- 101-4416A3
- Conditions
- Cleft Lip and Palate, Le Fort
- Keywords
- Cleft lip and palate, Cone-Beam Computed Tomography, Le Fort I Osteotomy, Segmental Osteotomy, Stability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 7 Jun 2013 (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.
Le Fort I osteotomy is often used in orthognathic surgery for patients to solve midface retrusion. It is known that post-surgical stability of Le Fort I osteotomy can be influenced by single jaw or bimaxillary procedures, fixation techniques or interpositional grafting. In patients with cleft lip and palate, the postoperative instability of Le Fort I osteotomy can be even worse due to scar tissue resulted from palate surgery. Segmental LeFort I osteotomy is another useful surgical modifications that can be easily done through the alveolar cleft. It is performed to allow the correction of differences in the occlusal planes, correction of transverse discrepancy or to facilitate an optimal occlusion. The most important benefits is that the alveolar cleft in patients who have not had alveolar bone graft surgery or failed to have successful result can be narrow down or even closed by approximation of two separating alveolar segments. However, there are limited previous studies comparing the stability of segmental versus one-piece Le Fort I osteotomy especially in patients with cleft. It is our aim to investigate whether one-piece Le Fort I osteotomy or segmental Le Fort I osteotomy can provide a better stability after surgery.
Detailed description
Measurements Skeletal movement
- Skeletal Surgical movement from T2 to T1
- positional change of landmarks in vertical from constructed Frankfurt plane
- positional change of landmarks in horizontal plane in relative to constructed coronal plane through Sella point
- Post-Surgical skeletal movement (Stability) from T3 to T2
- positional change of landmarks in vertical from constructed Frankfurt plane
- positional change of landmarks in horizontal plane in relative to constructed coronal plane through Sella point
- Skeletal angular measurement change on mid-sagittal plane from (T2 to T1) and (T3 to T2)
- Dental change measured from digital maxillary cast in transverse direction from (T2 to T1) and (T3 to T2)
- Facial Height / Facial Proportion changes from (T2 to T1) and (T3 to T2)
- Alveolar cleft width changes from (T2 to T1) and (T3 to T2)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Segmental Le Fort I Osteotomy | Experimental | Procedure: Segmental Le Fort I osteotomyFor some cases that bone filling over cleft site is not good enough for tooth movement, it is possible that we put them into this group which means by using Segmental Le Fort I Osteotomy to approximate two dental alveolar segments. |
| One-piece Le Fort I Osteotomy | Active comparator | Procedure: One-piece Le Fort I OsteotomyFor patients having ideal bone graft result over cleft site, traditional One-piece Le Fort I Osteotomy will be performed. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Cleft lip/palate patients
- Non growing Taiwanese adults, at least 18 years old for men and 16 years old for women
- Patients with midface retrusion and malocclusion that will need Le Fort I osteotomy
- Rigid fixation with bone plates
- Patients who signs the informed consent form
Key exclusion criteria (2 listed)
- Association with craniofacial anomalies
- Patient without complete 3D imaging records including CBCT scans and digital dental models
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 |
|---|---|---|
| Segmental Le Fort I osteotomyAlso: Segmental maxillary osteotomy, Maxillary Segmental osteotomycomparison the stability of segmental Le Fort I osteotomy with conventional approach of one-piece Le Fort I osteotomy | Procedure or surgery | Segmental Le Fort I Osteotomy |
| One-piece Le Fort I OsteotomyAlso: Le Fort I Osteotomy, Le Fort 1 Osteotomyconventional approach | Procedure or surgery | One-piece Le Fort I Osteotomy |
Primary outcome
stability and relapse rate of surgical movement
Time frame: 6 months after surgery & 1-2 years till the completion of the treatment
to compare the stability and relapse rate in vertical, horizontal and transverse among two kinds of different surgical techniuques
1 secondary outcome
Presence of pathological change of cleft-adjacent teeth
Time frame: immediate after surgery, 6 months after surgery & 2 years till the completion of the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2013.
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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.
Yu Fang Liao, Ph.D. study director
Chang Gung Craniofacial Center , Chang Gung Memorial Hospial , Taoyuan , Taiwa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Segmental Le Fort I osteotomy and One-piece Le Fort I Osteotomy in people with Cleft Lip and Palate and Le Fort, 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Jun 2013. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Ting Chiu, D.D.S., MS. (03-3196200 ext. 3500, tina1979@adm.cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stability and relapse rate of surgical movement (time frame: 6 months after surgery & 1-2 years till the completion of the treatment). 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 7 Jun 2013.