Quality of LifeNCT04021836
Three Dimensional Evaluation of Nasolabial Changes Following Classic vs Without Alar Base Suture After Le Fort I Osteotomy
A study testing 3d evaluation of nasolabial change in people with Quality of Life, run by Cairo University.
Trial summary
Three dimensional evaluation of nasolabial changes following classic vs without alar base suture after Le Fort I osteotomy A randomized controlled clinical trial Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Quality of Life
- What is being tested?
- 3d evaluation of nasolabial change
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2019to 15 Jul 2020
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients with skeletal maxillomandibular deformity indicated for surgical correction by Le Fort I osteotomy.
- Absence of growth.
- Patients must be willing for the surgical procedure and follow-up, with his informed consent.
Who cannot join
- 4. History of facial trauma with fractures of facial bones. 5. History of surgical operation in nasal region. 6. Facial asymmetry. 7. Patients with accompanying craniofacial syndromes. 8. Patients with any diseases that compromise bone or soft tissue healing. 9. Anterior open bite cases. 10. Clefts ( lip and palate). 11. Medically compromised patients not fit for general anaesthesia. 12. missing preoperative or postop-erative 3D photographs or CBCT scans 13. multi-segment Le Fort I osteotomy 14. rhinoplasty surgery during or within 1 year after the Le Fort I osteotomy
About this study
Three dimensional evaluation of nasolabial changes following classic vs without alar base suture after
Le Fort I osteotomy
A randomized controlled clinical trial
- Conditions
- Quality of Life
- Being tested
- 3d evaluation of nasolabial change
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3d evaluation of nasolabial changeOther
Evaluation of With vs without ala cinch suture after lefort 1 osteotomy
| Study group | Role | What they receive |
|---|---|---|
| 3d evaluation of naso labial changes using alar cinch suture | Other | Not described Receives: Other: 3d evaluation of nasolabial change |
| 3d evaluation of nasolabial change without Alar cinch | Other | Not described Receives: Other: 3d evaluation of nasolabial change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Widening of alar base
Widening of alar base
Measured: 6 months
Secondary outcomes (1)
Nasal volume
Nasal volume
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start15 Jul 2019 (estimated)
- Primary completion15 Jul 2020 (estimated)
- Study completion15 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three dimensional evaluation of nasolabial changes following classic vs without alar base suture after Le Fort I osteotomy
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Afraa Bushra Abdelkarim Jubara, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021836
- Sponsor's protocol ID
- 3DENB
- Status last verified
- Jul 2019
- First submitted
- 13 Jul 2019
- Last updated
- 16 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Dimensional Evaluation of Nasolabial Changes Following Classic vs Without Alar Base Suture After Le Fort I Osteotomy
- ClinicalTrials.gov ID
- NCT04021836
- Acronym / sponsor ID
- 3DENB
- Conditions
- Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jul 2019 (estimated)
- Primary completion
- 15 Jul 2020 (estimated)
- Study completion
- 15 Jul 2020 (estimated)
- First posted
- 16 Jul 2019 (actual)
- 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.
Three dimensional evaluation of nasolabial changes following classic vs without alar base suture after
Le Fort I osteotomy
A randomized controlled clinical trial
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Three dimensional evaluation of nasolabial changes following classic vs without alar base suture after Le Fort I osteotomy
| Arm | Type | Receives |
|---|---|---|
| 3d evaluation of naso labial changes using alar cinch suture | Other | Other: 3d evaluation of nasolabial change |
| 3d evaluation of nasolabial change without Alar cinch | Other | Other: 3d evaluation of nasolabial change |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult patients with skeletal maxillomandibular deformity indicated for surgical correction by Le Fort I osteotomy.
- Absence of growth.
- Patients must be willing for the surgical procedure and follow-up, with his informed consent.
Key exclusion criteria (1 listed)
- 4. History of facial trauma with fractures of facial bones. 5. History of surgical operation in nasal region. 6. Facial asymmetry. 7. Patients with accompanying craniofacial syndromes. 8. Patients with any diseases that compromise bone or soft tissue healing. 9. Anterior open bite cases. 10. Clefts ( lip and palate). 11. Medically compromised patients not fit for general anaesthesia. 12. missing preoperative or postop-erative 3D photographs or CBCT scans 13. multi-segment Le Fort I osteotomy 14. rhinoplasty surgery during or within 1 year after the Le Fort I osteotomy
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 |
|---|---|---|
| 3d evaluation of nasolabial changeEvaluation of With vs without ala cinch suture after lefort 1 osteotomy | Other | 3d evaluation of naso labial changes using alar cinch suture, 3d evaluation of nasolabial change without Alar cinch |
Primary outcome
Widening of alar base
Time frame: 6 months
Widening of alar base
1 secondary outcome
Nasal volume
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Individual participant dataSharing planned: Yes
Related trials for Quality of Life
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Recruiting
The Effectiveness of Structured Swallowing Exercise Therapy in Patients With Nasopharyngeal Carcinoma: An Assessment of Swallowing Function and Quality of Life
Nasopharyngeal Carcinoma (NPC)
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
RecruitingPhase 2
Estrogen to Improve Quality of Life for Men With Newly Diagnosed or Recurrent Metastatic Hormone Sensitive Prostate Cancer, EQUIP Trial
Castration-Sensitive Prostate Adenocarcinoma, Metastatic Castration-Sensitive Prostate Adenocarcinoma
Recruiting
Impact of a Structured Wellness Behavioral Intervention on Quality of Life in NMOSD
Neuromyelitis Optica Spectrum Disorder (NMOSD)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 3d evaluation of nasolabial change in people with Quality of Life, run by Cairo University.
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 3 inclusion and 1 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 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Widening of alar base (time frame: 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 16 Jul 2019.