Compression OsteogenesisNCT06045871
Evaluation of Surgical Correction of Anterior Vertical Maxillary Excess (Gummy Smile) by Compression Osteogenesis.
A study testing Corticotomy followed by compression osteogenesis in people with Compression Osteogenesis, run by Cairo University at 1 site in Egypt.
Trial summary
The technique of compression osteogenesis will be studied to verify its value as applied to manage anterior vertical maxillary excess in patients wohm are suffering from gummy smile. Read more about this study
- Who is it for?
- Ages 12 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Compression Osteogenesis
- What is being tested?
- Corticotomy followed by compression osteogenesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Jan 2022to 2 Feb 2023
- 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 12 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- patients suffering from anterior vertical maxillary excess that requires surgical intervention
Who cannot join
- total vertical maxillary excess Excessive horizontal maxillary excess Patients with systemic diseases that may affect normal bone healing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Surgical Correction of Anterior Vertical Maxillary Excess (Gummy Smile) by Compression.
The technique of compression osteogenesis will be studied to verify its value as applied to manage anterior vertical maxillary excess in patients wohm are suffering from gummy smile.
- Conditions
- Compression Osteogenesis
- Being tested
- Corticotomy followed by compression osteogenesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticotomy followed by compression osteogenesisProcedure or surgery
Surgical corticotomy supra apical in anterior maxilla then application of the compression osteogenesis concept via traction on miniscrews implanted above the corticotomy line
| Study group | Role | What they receive |
|---|---|---|
| Patients with anterior vertical maxillary excess (gummy smile) | Other | Not described Receives: Procedure: Corticotomy followed by compression osteogenesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring amount of vertical impaction of anterior maxilla after performing labial maxillary cotricotomy and activation of functional loading
Measuring amount of linear impaction (in millimeters) to evaluate validity of compression osteogenesis in treating gummy smile of a skeletal etiology ( due to increased anterior maxilla height) after performing labia maxillary corticotomy and activating functional loading using power chain elastics anchored on transmucosal mini- screws.
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 posted21 Sep 2023
- Study start31 Jan 2022
- Primary completion22 Aug 2022
- Study completion2 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compression OsteogenesisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Samir El-helaly, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045871
- Sponsor's protocol ID
- OMFS 3.3.2
- Status last verified
- Sep 2023
- First submitted
- 4 Sep 2023
- Last updated
- 21 Sep 2023
- 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 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Surgical Correction of Anterior Vertical Maxillary Excess (Gummy Smile) by Compression.
- ClinicalTrials.gov ID
- NCT06045871
- Acronym / sponsor ID
- OMFS 3.3.2
- Conditions
- Compression Osteogenesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 22 Aug 2022 (actual)
- Study completion
- 2 Feb 2023 (actual)
- First posted
- 21 Sep 2023 (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.
The technique of compression osteogenesis will be studied to verify its value as applied to manage anterior vertical maxillary excess in patients wohm are suffering from gummy smile.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with anterior vertical maxillary excess (gummy smile) | Other | Procedure: Corticotomy followed by compression osteogenesis |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- patients suffering from anterior vertical maxillary excess that requires surgical intervention
Key exclusion criteria (1 listed)
- total vertical maxillary excess Excessive horizontal maxillary excess Patients with systemic diseases that may affect normal bone healing
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 |
|---|---|---|
| Corticotomy followed by compression osteogenesisSurgical corticotomy supra apical in anterior maxilla then application of the compression osteogenesis concept via traction on miniscrews implanted above the corticotomy line | Procedure or surgery | Patients with anterior vertical maxillary excess (gummy smile) |
Primary outcome
Measuring amount of vertical impaction of anterior maxilla after performing labial maxillary cotricotomy and activation of functional loading
Time frame: 3 months
Measuring amount of linear impaction (in millimeters) to evaluate validity of compression osteogenesis in treating gummy smile of a skeletal etiology ( due to increased anterior maxilla height) after performing labia maxillary corticotomy and activating functional loading using power chain elastics anchored on transmucosal mini- screws.
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 21 Sep 2023.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corticotomy followed by compression osteogenesis in people with Compression Osteogenesis, run by Cairo University at 1 site in Egypt.
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 1 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: finished, as of the sponsor's last update on 21 Sep 2023. 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 Egypt. 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?
Measuring amount of vertical impaction of anterior maxilla after performing labial maxillary cotricotomy and activation of functional loading (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 21 Sep 2023.