Orthodontic Tooth MovementNCT04468295
Evaluation of the Rate of Maxillary En-masse Retraction Using 0.018-inch Versus 0.022-inch Slot Brackets in Adults
A study testing Bonding, Leveling and alignment and Extraction in people with Orthodontic Tooth Movement, run by Cairo University.
Trial summary
The study compares the rate of en-masse retraction using 0.018-inch versus 0.022-inch slot orthodontic bracket systems in adult patients with maxillary dentoalveolar protrusion. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Tooth Movement
- What is being tested?
- Bonding, Leveling and alignment and Extraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 28 Sep 2020to 28 Mar 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Maxillary dentoalveolar protrusion cases that require upper first premolars extraction.
- Full permanent dentition (not necessitating third molars).
- Good oral hygiene.
Who cannot join
- Patients having systemic diseases or on medications that would affect tooth movement.
- Active periodontal disease or obvious bone loss in maxillary arch.
- Patients with habits that are detrimental to dental occlusion (thumb sucking, tongue thrusting).
- Previous orthodontic treatment.
- Missing teeth.
About this study
Official title: Evaluation of the Rate of Maxillary En-masse Retraction Using 0.018-inch Versus 0.022-inch Slot Brackets in Adult Patients With Maxillary Dentoalveolar Protrusion: A Randomized Clinical Trial
The study compares the rate of en-masse retraction using 0.018-inch versus 0.022-inch slot orthodontic bracket systems in adult patients with maxillary dentoalveolar protrusion.
Read the detailed description
- Proper examination of the oral structures is needed to identify caries, fracture or missing teeth.
- Full set of records ( study models, lateral cephalometric radiographs, photos) will be taken for every patient as part of the routine procedure for treatment of patients in the outpatient clinic of the Orthodontic Department, Cairo University.
- In intervention group: Bonding of upper and lower arches including 2nd maxillary molars with bracket prescription Roth 0.018-inch (American Orthodontics).
- In comparator group: Bonding of upper and lower arches including 2nd maxillary molars with bracket prescription Roth 0.022-inch (American Orthodontics).
- Levelling and alignment in both groups with wire sequence: Ni-Ti (0.014,0.016, 0.016×0.022)
- Steel ligation of maxillary (2nd premolar, 1st molar and 2nd molar) for anchorage.
- Extraction of maxillary 1st premolars.
- Impression will be taken, poured in plaster from which digital models will be fabricated before beginning of en-masse retraction (the baseline model).
- Lateral cephalometric and periapical radiographs will be taken before starting retraction.
- En-masse retraction will be done using 0.017x0.025 TMA T-Loop10 in both groups, the loops will be reactivated monthly.
- Alginate impressions will be taken every month, that will be scanned to obtain digital models to assess the rate of retraction for 6 months.
- After 6 months, last obtained digital model will be evaluated for assessment of anchorage loss, and Lateral cephalometric and periapical radiographs will be taken to assess changes in the anterior teeth inclinations and apical root resorption respectively.
- The patients' treatment will be completed as indicated for them.
- Conditions
- Orthodontic Tooth Movement
- Being tested
- Bonding, Leveling and alignment, Extraction, Retraction, Digital models
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BondingProcedure or surgery
Bonding of upper and lower arches including 2nd maxillary molars with bracket prescription Roth 0.018 inch
Leveling and alignmentProcedure or surgery
Leveling and alignment till 0.016 x0.022 Ni Ti
ExtractionProcedure or surgery
Extraction of maxillary 1st premolars
RetractionProcedure or surgery
En-masse retraction using 0.017x0.025 TMA T loop
Digital modelsProcedure or surgery
impression taking and digital scanning
measurementProcedure or surgery
Assessment the rate of retraction for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 0.018-inch slot orthodontic bracket system | Experimental | En-masse retraction using frictionless mechanics with 0.018-inch slot orthodontic bracket system. Receives: Procedure: Bonding; Procedure: Leveling and alignment; Procedure: Extraction; Procedure: Retraction; Procedure: Digital models; Procedure: measurement |
| 0.022-inch slot orthodontic bracket system | Active comparator | En-masse retraction using frictionless mechanics with 0.022-inch slot orthodontic bracket system. Receives: Procedure: Bonding; Procedure: Leveling and alignment; Procedure: Extraction; Procedure: Retraction; Procedure: Digital models; Procedure: measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retraction Rate
The rate of en-masse retraction of the anterior teeth
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 posted13 Jul 2020
- Study start28 Sep 2020 (estimated)
- Primary completion28 Sep 2021 (estimated)
- Study completion28 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Tooth MovementStudies 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, Omar Abdelaziz, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468295
- Sponsor's protocol ID
- CEBC-CU-2020-07-09
- Status last verified
- Jul 2020
- First submitted
- 9 Jul 2020
- Last updated
- 14 Jul 2020
- 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 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Rate of Maxillary En-masse Retraction Using 0.018-inch Versus 0.022-inch Slot Brackets in Adult Patients With Maxillary Dentoalveolar Protrusion: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04468295
- Acronym / sponsor ID
- CEBC-CU-2020-07-09
- Conditions
- Orthodontic Tooth Movement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 28 Sep 2020 (estimated)
- Primary completion
- 28 Sep 2021 (estimated)
- Study completion
- 28 Mar 2022 (estimated)
- First posted
- 13 Jul 2020 (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 compares the rate of en-masse retraction using 0.018-inch versus 0.022-inch slot orthodontic bracket systems in adult patients with maxillary dentoalveolar protrusion.
Detailed description
- Proper examination of the oral structures is needed to identify caries, fracture or missing teeth.
- Full set of records ( study models, lateral cephalometric radiographs, photos) will be taken for every patient as part of the routine procedure for treatment of patients in the outpatient clinic of the Orthodontic Department, Cairo University.
- In intervention group: Bonding of upper and lower arches including 2nd maxillary molars with bracket prescription Roth 0.018-inch (American Orthodontics).
- In comparator group: Bonding of upper and lower arches including 2nd maxillary molars with bracket prescription Roth 0.022-inch (American Orthodontics).
- Levelling and alignment in both groups with wire sequence: Ni-Ti (0.014,0.016, 0.016×0.022)
- Steel ligation of maxillary (2nd premolar, 1st molar and 2nd molar) for anchorage.
- Extraction of maxillary 1st premolars.
- Impression will be taken, poured in plaster from which digital models will be fabricated before beginning of en-masse retraction (the baseline model).
- Lateral cephalometric and periapical radiographs will be taken before starting retraction.
- En-masse retraction will be done using 0.017x0.025 TMA T-Loop10 in both groups, the loops will be reactivated monthly.
- Alginate impressions will be taken every month, that will be scanned to obtain digital models to assess the rate of retraction for 6 months.
- After 6 months, last obtained digital model will be evaluated for assessment of anchorage loss, and Lateral cephalometric and periapical radiographs will be taken to assess changes in the anterior teeth inclinations and apical root resorption respectively.
- The patients' treatment will be completed as indicated for them.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.018-inch slot orthodontic bracket system | Experimental | Procedure: Bonding, Procedure: Leveling and alignment, Procedure: Extraction, Procedure: Retraction, Procedure: Digital models, Procedure: measurementEn-masse retraction using frictionless mechanics with 0.018-inch slot orthodontic bracket system. |
| 0.022-inch slot orthodontic bracket system | Active comparator | Procedure: Bonding, Procedure: Leveling and alignment, Procedure: Extraction, Procedure: Retraction, Procedure: Digital models, Procedure: measurementEn-masse retraction using frictionless mechanics with 0.022-inch slot orthodontic bracket system. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Maxillary dentoalveolar protrusion cases that require upper first premolars extraction.
- Full permanent dentition (not necessitating third molars).
- Good oral hygiene.
Key exclusion criteria (5 listed)
- Patients having systemic diseases or on medications that would affect tooth movement.
- Active periodontal disease or obvious bone loss in maxillary arch.
- Patients with habits that are detrimental to dental occlusion (thumb sucking, tongue thrusting).
- Previous orthodontic treatment.
- 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 |
|---|---|---|
| BondingBonding of upper and lower arches including 2nd maxillary molars with bracket prescription Roth 0.018 inch | Procedure or surgery | 0.018-inch slot orthodontic bracket system, 0.022-inch slot orthodontic bracket system |
| Leveling and alignmentLeveling and alignment till 0.016 x0.022 Ni Ti | Procedure or surgery | 0.018-inch slot orthodontic bracket system, 0.022-inch slot orthodontic bracket system |
| ExtractionExtraction of maxillary 1st premolars | Procedure or surgery | 0.018-inch slot orthodontic bracket system, 0.022-inch slot orthodontic bracket system |
| RetractionEn-masse retraction using 0.017x0.025 TMA T loop | Procedure or surgery | 0.018-inch slot orthodontic bracket system, 0.022-inch slot orthodontic bracket system |
| Digital modelsimpression taking and digital scanning | Procedure or surgery | 0.018-inch slot orthodontic bracket system, 0.022-inch slot orthodontic bracket system |
| measurementAssessment the rate of retraction for 6 months | Procedure or surgery | 0.018-inch slot orthodontic bracket system, 0.022-inch slot orthodontic bracket system |
Primary outcome
Retraction Rate
Time frame: 6 months
The rate of en-masse retraction of the anterior teeth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- 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.
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 Bonding, Leveling and alignment and Extraction in people with Orthodontic Tooth Movement, 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 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 Jul 2020. 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?
Retraction Rate (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 14 Jul 2020.