Maxillary PrognathismNCT06366737
En-mass Retraction by KILBON Versus CAT Appliances
A study testing KILBON Appliance and CAT appliance in people with Maxillary Prognathism, run by Cairo University at 1 site in Egypt.
Trial summary
en-mass retraction by lingual retractor versus clear alighner therapy Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Maxillary Prognathism
- What is being tested?
- KILBON Appliance and CAT appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2024to Aug 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult patients with maxillary dentoalveolar protrusion with mild crowding
Who cannot join
- - adult patients with maxillary dentoalveolar protrusion with moderate to severe crowding
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry
Cairo
zainab abdulrhman, 00201092445775, zeinab_mohammed@dentistry.cu.edu.eg
About this study
Official title: Effectiveness Of Lingual Retractor Versus Clear Aligner Appliances In En-mass Retraction Of Maxillary Anterior Teeth Segment In Adult Patients: A Randomized Clinical Trial
en-mass retraction by lingual retractor versus clear alighner therapy
Read the detailed description
Comparative Effectiveness Of Lingual Retractor Versus Clear Aligner Appliances In Adult Patients With Maxillary Dentoalveolar Protrusion Treated By Upper First Premolars Extraction And Enmass Retraction Of Maxillary Anterior Teeth Segment Using Palatal Orthodontic Miniscrews :A Randomized Clinical Trial
- Conditions
- Maxillary Prognathism
- Being tested
- KILBON Appliance, CAT appliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KILBON ApplianceDevice
palatal TAD assissted lingual appliance for en-mass retraction
CAT applianceDevice
palatal TAD assissted clear aligner
| Study group | Role | What they receive |
|---|---|---|
| KILBON appliance | Active comparator | en-mass retraction by lingual retractor Receives: Device: KILBON Appliance |
| CAT appliance | Active comparator | en-mass retraction by clear aligner Receives: Device: CAT appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction during & after phase I treatment.
questionnaire
Measured: 6 months
Secondary outcomes (1)
inclination of upper anterior teeth
angle measurement of long axis of maxillary central to maxillary plane in degrees
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 Apr 2024
- Study startOct 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary PrognathismStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeinab mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366737
- Sponsor's protocol ID
- CEBD-CU-2024-03-02
- Status last verified
- Sep 2024
- First submitted
- 28 Mar 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Of Lingual Retractor Versus Clear Aligner Appliances In En-mass Retraction Of Maxillary Anterior Teeth Segment In Adult Patients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06366737
- Acronym / sponsor ID
- CEBD-CU-2024-03-02
- Conditions
- Maxillary Prognathism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 16 Apr 2024 (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.
en-mass retraction by lingual retractor versus clear alighner therapy
Detailed description
Comparative Effectiveness Of Lingual Retractor Versus Clear Aligner Appliances In Adult Patients With Maxillary Dentoalveolar Protrusion Treated By Upper First Premolars Extraction And Enmass Retraction Of Maxillary Anterior Teeth Segment Using Palatal Orthodontic Miniscrews :A Randomized Clinical Trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KILBON appliance | Active comparator | Device: KILBON Applianceen-mass retraction by lingual retractor |
| CAT appliance | Active comparator | Device: CAT applianceen-mass retraction by clear aligner |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients with maxillary dentoalveolar protrusion with mild crowding
Key exclusion criteria (1 listed)
- - adult patients with maxillary dentoalveolar protrusion with moderate to severe crowding
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 |
|---|---|---|
| KILBON Appliancepalatal TAD assissted lingual appliance for en-mass retraction | Device | KILBON appliance |
| CAT appliancepalatal TAD assissted clear aligner | Device | CAT appliance |
Primary outcome
Patient satisfaction during & after phase I treatment.
Time frame: 6 months
questionnaire
1 secondary outcome
inclination of upper anterior teeth
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 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Maxillary Prognathism
Not yet recruiting
Treatment of Mandibular Overjet in Children With Maxillary Retrognathism
Maxillary Retrognathism, Children
Recruiting
3D Printed Reverse Twin Block for Class III Malocclusion
Class III Malocclusion
Recruiting
Nano Coated Orthodontic Miniscrews for en Mass Retraction of the Upper Arch
Class I Malocclusion, Maxillary Prognathism
Not yet recruiting
Effects of Invisalign Palatal Expander vs Rapid Palatal Expander With Facemask in Growing Class III Patients
Skeletal Class III Malocclusion, Transverse Maxillary Deficiency
Not yet recruiting
Comparison of Maxillary Protraction Using Tooth-borne Facemask Versus Skeletal Anchorage Chin-plate in Class III Growing Patients
Skeletal Class III Malocclusion
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KILBON Appliance and CAT appliance in people with Maxillary Prognathism, 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction during & after phase I treatment. (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 19 Sep 2024.