Orthodontic Appliance ComplicationNCT05277506
Smile Arc Assessment in Orthodontic Patients Following Smile Arc Protection VS MBT Placement Guide Bonding Strategies
A study testing 18 inch slot MBT orthodontic brackets bonded using smile arc protection bonding strategy and 18 inch slot MBT orthodontic brackets boned using MBT placement guide in people with Orthodontic Appliance Complication, run by Cairo University at 1 site in Egypt.
Trial summary
The study will be performed on human subjects undergoing orthodontic treatment to correct mild crowding with both techniques enhancing the final smile characteristics of the patients. Read more about this study
- Who is it for?
- Ages 16 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance Complication
- What is being tested?
- 18 inch slot MBT orthodontic brackets bonded using smile arc protection bonding strategy and 18 inch slot MBT orthodontic brackets boned using MBT placement guide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2022to Sep 2022
- 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 to 30 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- female patients
- no/mild/moderate crowding or spacing
- non-extraction treatment decision with non-extraction profile
- adults age 16-30 years
- full permanent dentition including fully erupted 7s not necessarily 8s
- good oral hygiene.
Who cannot join
- severe crowding
- cleft lip and palate/syndromic patients
- bad oral hygiene
- unerupted or partially erupted 7s
- extracted or missing teeth
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University, Faculty of Dentistry.
Cairo
Noura Saleh, BDS, 00201018261090, noura.mohamed@dentistry.cu.edu.eg
Mohamed Abd El-Ghafour, PhD, 00201007433288, m.abdelghafour@dentistry.cu.edu.eg
About this study
Official title: Smile Arc Assessment in Orthodontic Patients Following Smile Arc Protection Versus MBT Placement Guide Bonding Strategies: A Randomized Clinical Trial.
The study will be performed on human subjects undergoing orthodontic treatment to correct mild crowding with both techniques enhancing the final smile characteristics of the patients.
Read the detailed description
The study concisits of two groups, the intervention group entails performing bonding of orthodontic brackets following smile arc protection bonding strategy while the control group entails performing bonding using the MBT placement guide and comparing the final smile outcomes after reaching steel archwires for both groups using customized questionnaires for orthodontists and laypersons.
- Conditions
- Orthodontic Appliance Complication
- Being tested
- 18 inch slot MBT orthodontic brackets bonded using smile arc protection bonding strategy, 18 inch slot MBT orthodontic brackets boned using MBT placement guide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18 inch slot MBT orthodontic brackets bonded using smile arc protection bonding strategyDevice
female patients with mild crowding will recieve orthodontic brackets bonding using smile arc protection bonding strategy
18 inch slot MBT orthodontic brackets boned using MBT placement guideDevice
female patients with mild crowding will recieve orthodontic brackets bonding using MBT placement guide bonding strategy
| Study group | Role | What they receive |
|---|---|---|
| smile arc protection bonding strategy group | Experimental | female patients with mild crowding will recieve orthodontic brackets bonding using smile arc protection bonding strategy Receives: Device: 18 inch slot MBT orthodontic brackets bonded using smile arc protection bonding strategy |
| MBT placement guide group | Active comparator | female patients with mild crowding will recieve orthodontic brackets bonding using MBT placement guide Receives: Device: 18 inch slot MBT orthodontic brackets boned using MBT placement guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
smile arc assessment by orthodontists
subjective assessment of the beauty of the smile using close up photographs and questionnaires filled by orthodontists and graded scale from 0-10
Measured: 6 months follow up
Secondary outcomes (1)
smile arc analysis using frontal extraoral photographs of the posed smile
analysis in millimeters for anthropometric measurements
Measured: 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start10 Jan 2022
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Appliance ComplicationStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noura Mohamed Hamza Hassan Saleh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277506
- Sponsor's protocol ID
- ORTH 3-3-3
- Status last verified
- Mar 2022
- First submitted
- 18 Feb 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smile Arc Assessment in Orthodontic Patients Following Smile Arc Protection Versus MBT Placement Guide Bonding Strategies: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05277506
- Acronym / sponsor ID
- ORTH 3-3-3
- Conditions
- Orthodontic Appliance Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 14 Mar 2022 (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 study will be performed on human subjects undergoing orthodontic treatment to correct mild crowding with both techniques enhancing the final smile characteristics of the patients.
Detailed description
The study concisits of two groups, the intervention group entails performing bonding of orthodontic brackets following smile arc protection bonding strategy while the control group entails performing bonding using the MBT placement guide and comparing the final smile outcomes after reaching steel archwires for both groups using customized questionnaires for orthodontists and laypersons.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| smile arc protection bonding strategy group | Experimental | Device: 18 inch slot MBT orthodontic brackets bonded using smile arc protection bonding strategyfemale patients with mild crowding will recieve orthodontic brackets bonding using smile arc protection bonding strategy |
| MBT placement guide group | Active comparator | Device: 18 inch slot MBT orthodontic brackets boned using MBT placement guidefemale patients with mild crowding will recieve orthodontic brackets bonding using MBT placement guide |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- female patients
- no/mild/moderate crowding or spacing
- non-extraction treatment decision with non-extraction profile
- adults age 16-30 years
- full permanent dentition including fully erupted 7s not necessarily 8s
Key exclusion criteria (5 listed)
- severe crowding
- cleft lip and palate/syndromic patients
- bad oral hygiene
- unerupted or partially erupted 7s
- extracted or missing teeth
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 |
|---|---|---|
| 18 inch slot MBT orthodontic brackets bonded using smile arc protection bonding strategyfemale patients with mild crowding will recieve orthodontic brackets bonding using smile arc protection bonding strategy | Device | smile arc protection bonding strategy group |
| 18 inch slot MBT orthodontic brackets boned using MBT placement guidefemale patients with mild crowding will recieve orthodontic brackets bonding using MBT placement guide bonding strategy | Device | MBT placement guide group |
Primary outcome
smile arc assessment by orthodontists
Time frame: 6 months follow up
subjective assessment of the beauty of the smile using close up photographs and questionnaires filled by orthodontists and graded scale from 0-10
1 secondary outcome
smile arc analysis using frontal extraoral photographs of the posed smile
Time frame: 6 months follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18 inch slot MBT orthodontic brackets bonded using smile arc protection bonding strategy and 18 inch slot MBT orthodontic brackets boned using MBT placement guide in people with Orthodontic Appliance Complication, 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 6 inclusion and 5 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 14 Mar 2022. 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?
smile arc assessment by orthodontists (time frame: 6 months follow up). 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 14 Mar 2022.