Orthodontic TreatmentNCT04549948
Curve of Spee: Speed of Leveling Using Different Orthodontic Archwires
A study testing 0.017X0.025 Stainless steel, 0.019X0.025 Stainless steel and 0.021X0.025 B-Titanium archwire in people with Orthodontic Treatment, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial summary
The objectives if this study was to evaluate the efficacy of 3 different rectangular archwires in the correction of the curve of Spee (COS), to record the time needed to level excessive COS in the mandibular arch using the 3 archwire sizes, to investigate the changes in intercanine and intermolar widths and arch… Read more about this study
- Who is it for?
- Ages 16 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Treatment
- What is being tested?
- 0.017X0.025 Stainless steel, 0.019X0.025 Stainless steel and 0.021X0.025 B-Titanium archwire
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteJordan
- Study dates
- 1 Dec 2018to 30 Jun 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 and ≤ 30 years
- Overbite covering more than half of the lower incisor height
- Curve of Spee ≥ 4 millimeters
- Mild crowding in lower arch where non-extraction treatment is indicated.
- Normally inclined or retroclined lower incisors
- Averaged or reduced lower vertical height
- Good oral hygiene and healthy periodontium
- All permanent teeth are present except for the third molars
Who cannot join
- Severe crowding in lower arch where extraction treatment is indicated.
- Missing permanent molars or Premolars
- Poor oral hygiene and Periodontal disease
- Systemic health problems and medications were taken
- History of previous orthodontic treatment
- Smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Curve of Spee: Speed of Leveling Using Different Orthodontic Archwire Size and Material - A Randomized Clinical Trial
The objectives if this study was to evaluate the efficacy of 3 different rectangular archwires in the correction of the curve of Spee (COS), to record the time needed to level excessive COS in the mandibular arch using the 3 archwire sizes, to investigate the changes in intercanine and intermolar widths and arch length during leveling, to measure the arterio-posterior and vertical movement for the lower incisors and lower molars, to record pulpal blood flow and to detect the root resorption in the lower anterior teeth associated with leveling excessive COS using the 3 different archwires.
Read the detailed description
Fifty one subjects with an excessive COS were included in this study. The subjects will be randomly divided into three groups; Group one (17 patients): leveling of COS using 0.017X0.025-inch stainless steel archwire. Group two (17 patients): leveling of COS using 0.019X0.025-inch stainless steel archwire. Group three (17 patients): leveling of COS using 0.021X0.025-inch Titanium molybdenum archwire.
In the three groups, a 5mm depth reverse COS will be inserted. Records consisted of lateral cephalograms (pre-treatment, at T0 and post-treatment), peri-apical radiographs (at T0 and at T5), study casts (pre-treatment and at each time point during the tudy). Patients will be followed up on monthly visits without removing leveling archwires where alginate impressions were taken for the lower arch. Pain scores during the first week of leveling will be recorded using visual analogue scale (VAS).The amount of COS correction in mm, changes in intercanine in mm, intermolar and arch length in mm, pain scores and lower incisors root resorptions in mm will be measured.
- Conditions
- Orthodontic Treatment
- Being tested
- 0.017X0.025 Stainless steel, 0.019X0.025 Stainless steel, 0.021X0.025 B-Titanium archwire
- Keywords
- root resorption, pain, pulpal blood flow
- Medical subject headings
- Root Resorption, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.017X0.025 Stainless steelProcedure or surgery
Leveling curve of Sppe using 0.017X0.025 SS archwire
0.019X0.025 Stainless steelProcedure or surgery
Leveling curve of Sppe using 0.019X0.025 Stainless steel archwire
0.021X0.025 B-Titanium archwireProcedure or surgery
Leveling curve of Sppe using 0.019X0.025 B-Titanium archwire
| Study group | Role | What they receive |
|---|---|---|
| 0.017X0.025 Stainless Steel Archwire | Experimental | Leveling of COS using 0.017X0.025 Stainless Steel (SS) Archwire A reverse COS using 0.017X0.025 SS was used to correct the excessive COS in the lower arch. Receives: Procedure: 0.017X0.025 Stainless steel |
| 0.019X0.025 Stainless Steel Archwire | Experimental | A reverse COS using 0.019X0.025 SS was used to correct the excessive COS in the lower arch. Receives: Procedure: 0.019X0.025 Stainless steel |
| 0.021X0.025 TMA archwire | Experimental | A reverse COS using 0.021X0.025 TMA archwire was used to correct the excessive COS in the lower arch. Receives: Procedure: 0.021X0.025 B-Titanium archwire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Curve of Spee depth changes during leveling
The change in Curve of Spee in millimetres
Measured: 4 to 6 months
Secondary outcomes (3)
Pain perception
A10-point visual analogue scale of 10 cm length where 0 indicate no pain and 10 indicate intolerable pain
Measured: one week
Root Resorption
change in root length in millimeters
Measured: 6 months
Pulpal blood flow
Change in blood flow using laser flowmetry
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start1 Dec 2018
- Primary completion30 Sep 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthodontic TreatmentStudies 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
- Leveling of the curve of Spee
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 51 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 Abu Alhaija, PhD, Principal investigator, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549948
- Sponsor's protocol ID
- 436/2018
- Status last verified
- Sep 2020
- First submitted
- 9 Sep 2020
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ba-Hattab R, Abu Alhaija ES, Nasrawi YH, Taha N, Daher H, Daher S. Leveling the curve of Spee using different sized archwires: a randomized clinical trial of blood flow changes. Clin Oral Investig. 2023 Jun;27(6):2943-2955. doi: 10.1007/s00784-023-04894-7. Epub 2023 Feb 11.
PubMed 36773128
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Curve of Spee: Speed of Leveling Using Different Orthodontic Archwire Size and Material - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04549948
- Acronym / sponsor ID
- 436/2018
- Conditions
- Orthodontic Treatment
- Keywords
- root resorption, pain, pulpal blood flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 16 Sep 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 objectives if this study was to evaluate the efficacy of 3 different rectangular archwires in the correction of the curve of Spee (COS), to record the time needed to level excessive COS in the mandibular arch using the 3 archwire sizes, to investigate the changes in intercanine and intermolar widths and arch length during leveling, to measure the arterio-posterior and vertical movement for the lower incisors and lower molars, to record pulpal blood flow and to detect the root resorption in the lower anterior teeth associated with leveling excessive COS using the 3 different archwires.
Detailed description
Fifty one subjects with an excessive COS were included in this study. The subjects will be randomly divided into three groups; Group one (17 patients): leveling of COS using 0.017X0.025-inch stainless steel archwire. Group two (17 patients): leveling of COS using 0.019X0.025-inch stainless steel archwire. Group three (17 patients): leveling of COS using 0.021X0.025-inch Titanium molybdenum archwire.
In the three groups, a 5mm depth reverse COS will be inserted. Records consisted of lateral cephalograms (pre-treatment, at T0 and post-treatment), peri-apical radiographs (at T0 and at T5), study casts (pre-treatment and at each time point during the tudy). Patients will be followed up on monthly visits without removing leveling archwires where alginate impressions were taken for the lower arch. Pain scores during the first week of leveling will be recorded using visual analogue scale (VAS).The amount of COS correction in mm, changes in intercanine in mm, intermolar and arch length in mm, pain scores and lower incisors root resorptions in mm will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Leveling of the curve of Spee
| Arm | Type | Receives |
|---|---|---|
| 0.017X0.025 Stainless Steel Archwire | Experimental | Procedure: 0.017X0.025 Stainless steelLeveling of COS using 0.017X0.025 Stainless Steel (SS) Archwire A reverse COS using 0.017X0.025 SS was used to correct the excessive COS in the lower arch. |
| 0.019X0.025 Stainless Steel Archwire | Experimental | Procedure: 0.019X0.025 Stainless steelA reverse COS using 0.019X0.025 SS was used to correct the excessive COS in the lower arch. |
| 0.021X0.025 TMA archwire | Experimental | Procedure: 0.021X0.025 B-Titanium archwireA reverse COS using 0.021X0.025 TMA archwire was used to correct the excessive COS in the lower arch. |
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 and ≤ 30 years
- Overbite covering more than half of the lower incisor height
- Curve of Spee ≥ 4 millimeters
- Mild crowding in lower arch where non-extraction treatment is indicated.
- Normally inclined or retroclined lower incisors
Key exclusion criteria (6 listed)
- Severe crowding in lower arch where extraction treatment is indicated.
- Missing permanent molars or Premolars
- Poor oral hygiene and Periodontal disease
- Systemic health problems and medications were taken
- History of previous orthodontic treatment
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 |
|---|---|---|
| 0.017X0.025 Stainless steelLeveling curve of Sppe using 0.017X0.025 SS archwire | Procedure or surgery | 0.017X0.025 Stainless Steel Archwire |
| 0.019X0.025 Stainless steelLeveling curve of Sppe using 0.019X0.025 Stainless steel archwire | Procedure or surgery | 0.019X0.025 Stainless Steel Archwire |
| 0.021X0.025 B-Titanium archwireLeveling curve of Sppe using 0.019X0.025 B-Titanium archwire | Procedure or surgery | 0.021X0.025 TMA archwire |
Primary outcome
Curve of Spee depth changes during leveling
Time frame: 4 to 6 months
The change in Curve of Spee in millimetres
3 secondary outcomes
Pain perception
Time frame: one week
Root Resorption
Time frame: 6 months
Pulpal blood flow
Time frame: one month
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 22 Sep 2020.
- Derived from this study: PubMed 36773128Ba-Hattab R, Abu Alhaija ES, Nasrawi YH, Taha N, Daher H, Daher S. Leveling the curve of Spee using different sized archwires: a randomized clinical trial of blood flow changes. Clin Oral Investig. 2023 Jun;27(6):2943-2955. doi: 10.1007/s00784-023-04894-7. Epub 2023 Feb 11.
- Individual participant dataSharing planned: Undecided
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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 Abu 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 0.017X0.025 Stainless steel, 0.019X0.025 Stainless steel and 0.021X0.025 B-Titanium archwire in people with Orthodontic Treatment, 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 22 Sep 2020. 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?
Curve of Spee depth changes during leveling (time frame: 4 to 6 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 NCT04549948, which also lists 1 linked publication.
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 22 Sep 2020.