Orthodontic ApplianceNCT04598490
Speed of Premolar Extraction Space Closure: Healed vs Recent Extraction Site
A study testing Space closure into old extraction space and Space closure into recent extraction space in people with Orthodontic Appliance, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial summary
The aim was to compare the rate of teeth movement into fresh and old extraction sites. Read more about this study
- Who is it for?
- Ages 16 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance
- What is being tested?
- Space closure into old extraction space and Space closure into recent extraction space
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteJordan
- Study dates
- 1 Dec 2018to 1 Aug 2020
- 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
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age ≥ 16 years
- Proclined upper and lower incisors (Ui/max >115 o, Li/mand >99o)
- Mild upper and lower arch crowding (<4mm) or no crowding
- Need for upper and lower first premolars extraction
- Skeletal I malocclusion (1<ANB <5)
- Average lower facial height and maxillomandibular plane angle (22 o <MM<32 o)
- Class I canine relationship
- Good oral hygiene and healthy periodontium
Who cannot join
- Poor oral hygiene
- Diseases and medications that were likely to affect bone biology
- Previous orthodontic treatment
- Evidence of bone loss
- Active periodontal disease
- Smoking
Trial locations and contacts
1 site in 1 country.
Jordan1 site
Faculty of Dentistry/Jordan University of Science and Technology Dental Teaching Clinics
Irbid
About this study
Official title: Speed of Premolar Extraction Space Closure: Healed vs Recent Extraction Site- A Prospective Randomized Clinical Trial
The aim was to compare the rate of teeth movement into fresh and old extraction sites.
Read the detailed description
Trial design: Randomized controlled clinical trial with a split mouth design. Setting: Jordan University of Science and Technology(JUST) Postgraduate Dental Teaching Clinics and labs.
Participants and interventions: Twenty-eight subjects with bimaxillary proclination requiring extraction of all first premolar teeth participated in this study. In the lower arch, two groups were also identified; group 1 having the first premolar extracted before the commencement of orthodontic treatment and group 2 having the first premolar extracted just before space closure when 0.019 x 0.025 inch SS archwire was reached. Patients were followed-up monthly for three months. At every follow-up visit lower alginate impressions were taken. Extraction spaces in the lower arch follow-up models were measured using digital caliper.
The rate of extraction space closure in the lower arch was assessed monthly.
- Conditions
- Orthodontic Appliance
- Being tested
- Space closure into old extraction space, Space closure into recent extraction space
- Keywords
- recent, healed, extraction space
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Space closure into old extraction spaceDevice
Lower first premolar extraction space was closed using elastic power chain and 0.019X0.025 Stainless steel archwire into healed bony socket
Space closure into recent extraction spaceDevice
Lower first premolar extraction space was closed using elastic power chain and 0.019X0.025 Stainless steel archwire into fresh bony socket
| Study group | Role | What they receive |
|---|---|---|
| Healed extraction site | Experimental | Old Extraction Space Receives: Device: Space closure into old extraction space |
| unhealed extraction site | Experimental | Recent Extraction space Receives: Device: Space closure into recent extraction space |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of space closure
Width of extraction space will be measured in millimeters
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 posted22 Oct 2020
- Study start1 Dec 2018
- Primary completion1 Sep 2019
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic ApplianceStudies of the same condition, open and under way.
- 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
- Model description
- Space closure into old extraction space
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elham Abu Alhaija, Jordan University of Science and Technology
- Investigators
- Elham S A Alhaija, PhD, Principal investigator, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598490
- Sponsor's protocol ID
- 53b/2019
- Status last verified
- Sep 2021
- First submitted
- 9 Sep 2020
- Last updated
- 4 Oct 2021
- 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 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speed of Premolar Extraction Space Closure: Healed vs Recent Extraction Site- A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04598490
- Acronym / sponsor ID
- 53b/2019
- Conditions
- Orthodontic Appliance
- Keywords
- recent, healed, extraction space
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 22 Oct 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 aim was to compare the rate of teeth movement into fresh and old extraction sites.
Detailed description
Trial design: Randomized controlled clinical trial with a split mouth design. Setting: Jordan University of Science and Technology(JUST) Postgraduate Dental Teaching Clinics and labs.
Participants and interventions: Twenty-eight subjects with bimaxillary proclination requiring extraction of all first premolar teeth participated in this study. In the lower arch, two groups were also identified; group 1 having the first premolar extracted before the commencement of orthodontic treatment and group 2 having the first premolar extracted just before space closure when 0.019 x 0.025 inch SS archwire was reached. Patients were followed-up monthly for three months. At every follow-up visit lower alginate impressions were taken. Extraction spaces in the lower arch follow-up models were measured using digital caliper.
The rate of extraction space closure in the lower arch was assessed monthly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Space closure into old extraction space
| Arm | Type | Receives |
|---|---|---|
| Healed extraction site | Experimental | Device: Space closure into old extraction spaceOld Extraction Space |
| unhealed extraction site | Experimental | Device: Space closure into recent extraction spaceRecent Extraction space |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Age ≥ 16 years
- Proclined upper and lower incisors (Ui/max >115 o, Li/mand >99o)
- Mild upper and lower arch crowding (<4mm) or no crowding
- Need for upper and lower first premolars extraction
- Skeletal I malocclusion (1<ANB <5)
Key exclusion criteria (6 listed)
- Poor oral hygiene
- Diseases and medications that were likely to affect bone biology
- Previous orthodontic treatment
- Evidence of bone loss
- Active periodontal disease
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 |
|---|---|---|
| Space closure into old extraction spaceLower first premolar extraction space was closed using elastic power chain and 0.019X0.025 Stainless steel archwire into healed bony socket | Device | Healed extraction site |
| Space closure into recent extraction spaceLower first premolar extraction space was closed using elastic power chain and 0.019X0.025 Stainless steel archwire into fresh bony socket | Device | unhealed extraction site |
Primary outcome
Amount of space closure
Time frame: 3 months
Width of extraction space will be measured in millimeters
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 4 Oct 2021.
- 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.
Elham S A Alhaija, PhD principal investigator
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Space closure into old extraction space and Space closure into recent extraction space in people with Orthodontic Appliance, run by Jordan University of Science and Technology at 1 site in Jordan.
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 8 inclusion and 6 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 4 Oct 2021. 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 Jordan. 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?
Amount of space closure (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 4 Oct 2021.