Frequency of Root ParalellismNCT04139174
Assessment of Root Parallelism Following Orthodontic Treatment in Adolescent vs Adult Patients Treated With Maxillary First Premolar Extraction
An observational study of Frequency of Root Paralellism, run by Cairo University.
Trial summary
Panoramic radiographs of finished orthodontic cases will be collected after fulfilling the inclusion and exclusion criteria. Then the collected data will be divided into two groups according to age either adolescent (12-18 years old) or adult group (after 18 years old). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Frequency of Root Paralellism
- What is being tested?
- first premolar extraction and complete canine retraction.
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2019to 1 Sep 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: the collected data will be divided into two groups according to age either adolescent (12-18 years old) or adult group (after 18 years old).
Who may be able to join
- Adults group of Patients (above 18 years old). .
- Adolescent group of patients (from 12 to 18 years old).
- Extraction of permanent maxillary first premolar in at least one quadrant.
- Same head position at scanning time.
- Same machine: Orthopantomograph Planmeca Promax 2P (Planmeca USA) with a kilovoltage of 55 to 85 and an exposure time of 15 seconds at a focal distance of 46 cm.
- Same type of bracket (Roth prescription, slot size #22).
- Full set of teeth (not necessarily including third molars)
Who cannot join
- Systematic diseases.
- non extraction cases.
- severe divergence or convergence between roots of maxillary canine and second premolar.
About this study
Official title: Assessment of Root Parallelism Following Orthodontic Treatment in Adolescent vs Adult Patients Treated With Maxillary First Premolar Extraction: Observational -Analytical Study
Panoramic radiographs of finished orthodontic cases will be collected after fulfilling the inclusion and exclusion criteria. Then the collected data will be divided into two groups according to age either adolescent (12-18 years old) or adult group (after 18 years old).
in the panoramic views the long axes of canines and second premolar will be traced digitally using Digital softwares (microDicom vierwer Simeo Antonov Stoykov 0.7.7) \& (IC Measure 2.0.0.161).
The objective of this study is to assess the root parallelism between maxillary canines and second premolars in adolescents versus adults group of patients requiring maxillary first premolar extraction during the orthodontic treatment.
- Conditions
- Frequency of Root Paralellism
- Being tested
- first premolar extraction and complete canine retraction.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
first premolar extraction and complete canine retraction.Procedure or surgery
measurements on panoramic radiograph will be done after first premolar extraction and complete canine retraction.
| Study group | Role | What they receive |
|---|---|---|
| adolescent group | Panoramic radiographs of finished orthodontic cases will be collected after fulfilling the inclusion and exclusion criteria. Then the collected data will be divided into two groups according to age either adolescent (12-18 years old) or adult group (after 18 years old).
measurements will be done on the radiograph using digital software. Receives: Procedure: first premolar extraction and complete canine retraction. | |
| adult group | Panoramic radiographs of finished orthodontic cases will be collected after fulfilling the inclusion and exclusion criteria. Then the collected data will be divided into two groups according to age either adolescent (12-18 years old) or adult group (after 18 years old).
measurements will be done on the radiograph using digital software. Receives: Procedure: first premolar extraction and complete canine retraction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Good Root Parallelism
root paralellism between canine and second premolar
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start1 Nov 2019 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Frequency of Root ParalellismStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina adly kaldas, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139174
- Sponsor's protocol ID
- orthodontics 3-3-4
- Status last verified
- Oct 2019
- First submitted
- 23 Oct 2019
- Last updated
- 28 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Oshagh M, Momenidanaei S, Sardarian A, Alipour A, Roeinpeykar M, Khaksar Y. Root Parallelism of Canine and Second Premolar. 2014;3(3):176-81.
Mayoral G. Treatment results with light wires studied by panoramic radiography. Am J Orthod. 1982 Jun;81(6):489-97. doi: 10.1016/0002-9416(82)90428-6.
PubMed 6960734
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Root Parallelism Following Orthodontic Treatment in Adolescent vs Adult Patients Treated With Maxillary First Premolar Extraction: Observational -Analytical Study
- ClinicalTrials.gov ID
- NCT04139174
- Acronym / sponsor ID
- orthodontics 3-3-4
- Conditions
- Frequency of Root Paralellism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 25 Oct 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.
Panoramic radiographs of finished orthodontic cases will be collected after fulfilling the inclusion and exclusion criteria. Then the collected data will be divided into two groups according to age either adolescent (12-18 years old) or adult group (after 18 years old).
in the panoramic views the long axes of canines and second premolar will be traced digitally using Digital softwares (microDicom vierwer Simeo Antonov Stoykov 0.7.7) \& (IC Measure 2.0.0.161).
The objective of this study is to assess the root parallelism between maxillary canines and second premolars in adolescents versus adults group of patients requiring maxillary first premolar extraction during the orthodontic treatment.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adolescent group | – | Procedure: first premolar extraction and complete canine retraction.Panoramic radiographs of finished orthodontic cases will be collected after fulfilling the inclusion and exclusion criteria. Then the collected data will be divided into two groups according to age either adolescent (12-18 years old) or adult group (after 18 years old). measurements will be done on the radiograph using digital software. |
| adult group | – | Procedure: first premolar extraction and complete canine retraction.Panoramic radiographs of finished orthodontic cases will be collected after fulfilling the inclusion and exclusion criteria. Then the collected data will be divided into two groups according to age either adolescent (12-18 years old) or adult group (after 18 years old). measurements will be done on the radiograph using digital software. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- the collected data will be divided into two groups according to age either adolescent (12-18 years old) or adult group (after 18 years old).
Key inclusion criteria (7 listed)
- Adults group of Patients (above 18 years old). .
- Adolescent group of patients (from 12 to 18 years old).
- Extraction of permanent maxillary first premolar in at least one quadrant.
- Same head position at scanning time.
- Same machine: Orthopantomograph Planmeca Promax 2P (Planmeca USA) with a kilovoltage of 55 to 85 and an exposure time of 15 seconds at a focal distance of 46 cm.
Key exclusion criteria (3 listed)
- Systematic diseases.
- non extraction cases.
- severe divergence or convergence between roots of maxillary canine and second premolar.
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 |
|---|---|---|
| first premolar extraction and complete canine retraction.measurements on panoramic radiograph will be done after first premolar extraction and complete canine retraction. | Procedure or surgery | adolescent group, adult group |
Primary outcome
Frequency of Good Root Parallelism
Time frame: 8 months
root paralellism between canine and second premolar
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
- BackgroundOshagh M, Momenidanaei S, Sardarian A, Alipour A, Roeinpeykar M, Khaksar Y. Root Parallelism of Canine and Second Premolar. 2014;3(3):176-81.
- Results publication: PubMed 6960734Mayoral G. Treatment results with light wires studied by panoramic radiography. Am J Orthod. 1982 Jun;81(6):489-97. doi: 10.1016/0002-9416(82)90428-6.
- Individual participant dataSharing planned: Undecided
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?
An observational study of Frequency of Root Paralellism, 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 7 inclusion and 3 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 28 Oct 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?
Frequency of Good Root Parallelism (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04139174, which also lists 2 linked publications.
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 28 Oct 2019.