Labial Alveolar Bone ThicknessNCT02816489
Labial Alveolar Bone Thickness and Apical Root Resorption Changes Associated With Self-ligating Versus Conventional Brackets
A study testing Clarity SL MBT brackets; 3M Unitek, Monrovia, CA, USA and Gemini MBT brackets; 3M Unitek, Monrovia, CA, USA in people with Labial Alveolar Bone Thickness and Apical Root Resorption, run by Mansoura University at 1 site in Egypt.
Trial summary
Labial alveolar bone thickness and apical root resorption changes associated with self-ligating versus conventional brackets. The aim of this study will be to compare labial alveolar bone thickness and apical root resorption changes associated with self-ligating versus conventional brackets. Read more about this study
- Who is it for?
- Ages 14 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Labial Alveolar Bone Thickness, Apical Root Resorption
- What is being tested?
- Clarity SL MBT brackets; 3M Unitek, Monrovia, CA, USA and Gemini MBT brackets; 3M Unitek, Monrovia, CA, USA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteEgypt
- Study dates
- May 2016to Jan 2017
- 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 14 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age ranged between 14-20 years.
- Complete permanent dentition (excluding third molars).
- Angle Class I malocclusion.
- Crowding anteriorly ranging from 2 to 4 mm.
- Healthy young patients.
Who cannot join
- Patients with signs of apical root resorption detected at the first examination by periapical radiographs.
- Blocked-out or High-up canines.
- Patients who went to previous orthodontic treatment.
- Evidence of periodontal or gingival problems.
- Endodontic treatment.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Study site
Al Mansurah
Nader Giacaman, Master student, 00201100769353, thevictoryspirit@hotmail.com
About this study
Official title: A Randomized Clinical Trial to Evaluate Labial Alveolar Bone Thickness and Apical Root Resorption Between Two Kinds of Brackets Using CBCT
Labial alveolar bone thickness and apical root resorption changes associated with self-ligating versus conventional brackets.
The aim of this study will be to compare labial alveolar bone thickness and apical root resorption changes associated with self-ligating versus conventional brackets.
Read the detailed description
Labial alveolar bone thickness and apical root resorption changes associated with self-ligating versus conventional brackets.
Protocol submitted in partial fulfillment for the requirements of Master Degree in Orthodontics.
The initial stage of treatment crowding permanent teeth orthodontically is worried about teeth leveling and alignment. The accuracy of this procedure depends on various variables.
Friction is generated upon the materialistic composition of different bracket and archwire types, and the technique of ligature between them.
Several self-ligating brackets have been grown since 1935. Self-ligation doesn't need for an elastomeric attachment to catch the archwire, so it is related with a highly reduced friction with many different types of archwires, therefore less force required.
It is valuable to evaluate any appliance system for its capability to align teeth with minimal injurious effects to the oral tissues.
The aim of this study will be to compare labial alveolar bone thickness and apical root resorption changes associated with self-ligating versus conventional brackets.
Subjects and method
Study design:
Randomized controlled clinical trial
Study setting and population:
The sample of this study will be consisted of twenty one patients selected from Outpatient Clinic, Orthodontic Department, Faculty of Dentistry, Mansoura University.
Interventions:
The patients will be divided randomly into two groups and will be treated separately as follows:
- Group I: will be treated using passive self-ligating ceramic orthodontic brackets with stainless steel archwire slot liner.
- Group II: will be treated using conventional stainless steel orthodontic brackets ligated with elastomeric ligature.
The patients will be treated orthodontically within the initial leveling and alignment for the 6 month duration beginning with the same sequence of 0.014, 0.016, 0.016 × 0.022 inch nickel-titanium archwires and 0.016 × 0.022 inch stainless-steel archwire. Each archwire will be remained for 1.5 months, and it will be replaced with the previously mentioned sequence. For group II, the archwires will be attached to the brackets by using an elastomeric ligature. CBCT will be obtained in two time intervals, before beginning the orthodontic treatment and 6 months after it. Dental stripping and extraction of premolars will be eliminated.
Records:
For all patients the following records will be taken before and after leveling and alignment:
- Standardized upper and lower study casts.
- Standardized periapical radiograph.
- Standardized extra-oral and intra-oral photographs.
- Standardized cone beam computed tomography (CBCT).
Observations:
Sagittal cuts of upper and lower incisors in the center of the long axis will be selected. The labial alveolar bone thickness (LABT) of each incisor will be determined at the site neighboring to the widest point of the labiopalatal root in two levels separated by 3 mm (L1 and L2, respectively); these levels will be set along the long axis of the incisor and located every 3 mm from the cementoenamel junction (CEJ) level. Labial alveolar bone thickness will be assessed at the cervical level (L1) and midroot level (L2) at T0 and T1. Furthermore, the apical root resorption (ARR) will be calculated by determining the difference in the total tooth length, which will be measured in millimeters from the incisal border to the root apex, between T0 and T1 (T1-T0).
Ethical consideration:
All patients will receive information about the future clinical trial study and give their consent by signing an informed consent.
Data management and analysis: All statistical analysis will be performed with SPSS software. Differences will be considered significant at P values less than 0.05.
- Being tested
- Clarity SL MBT brackets; 3M Unitek, Monrovia, CA, USA, Gemini MBT brackets; 3M Unitek, Monrovia, CA, USA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clarity SL MBT brackets; 3M Unitek, Monrovia, CA, USADevice
Also called Clarity SL
(passive self-ligating ceramic orthodontic brackets with stainless steel archwire slot liner)
Gemini MBT brackets; 3M Unitek, Monrovia, CA, USADevice
Also called Gemini
(conventional stainless steel orthodontic brackets ligated with elastomeric ligature)
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | will be treated using passive self-ligating ceramic orthodontic brackets with stainless steel archwire slot liner (3M Unitek - USA).
Intervention: Device: passive self-ligating ceramic orthodontic brackets with stainless steel archwire slot liner (3M Unitek - USA). Receives: Device: Clarity SL MBT brackets; 3M Unitek, Monrovia, CA, USA |
| Group II | Experimental | will be treated using conventional stainless steel orthodontic brackets ligated with elastomeric ligature (3M Unitek - USA).
Intervention: Device: conventional stainless steel orthodontic brackets ligated with elastomeric ligature (3M Unitek - USA). Receives: Device: Gemini MBT brackets; 3M Unitek, Monrovia, CA, USA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Labial alveolar bone thickness
Labial alveolar bone thickness will be measured in millimeters using CBCT at the site neighboring to the widest point of the labiopalatal root in two levels separated by 3 mm (L1 and L2, respectively); these levels were set along the long axis of the incisor and located every 3 mm from the cementoenamel junction (CEJ) level. Labial alveolar bone thickness was assessed at the cervical level (L1) and midroot level (L2) at T0 and T1.
Measured: Change from baseline in Labial alveolar bone thickness at 6 months
Apical root resorption
Apical root resorption will be measured in millimeters using CBCT by determining the difference in the total tooth length, which was measured from the incisal border to the root apex, between T0 and T1 (T1-T0).
Measured: Change from baseline in Apical root resorption at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labial Alveolar Bone ThicknessStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816489
- Sponsor's protocol ID
- 9046380
- Status last verified
- May 2016
- First submitted
- 30 May 2016
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial to Evaluate Labial Alveolar Bone Thickness and Apical Root Resorption Between Two Kinds of Brackets Using CBCT
- ClinicalTrials.gov ID
- NCT02816489
- Acronym / sponsor ID
- 9046380
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jan 2017 (estimated)
- First posted
- 28 Jun 2016 (estimated)
- 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.
Labial alveolar bone thickness and apical root resorption changes associated with self-ligating versus conventional brackets.
The aim of this study will be to compare labial alveolar bone thickness and apical root resorption changes associated with self-ligating versus conventional brackets.
Detailed description
Labial alveolar bone thickness and apical root resorption changes associated with self-ligating versus conventional brackets.
Protocol submitted in partial fulfillment for the requirements of Master Degree in Orthodontics.
The initial stage of treatment crowding permanent teeth orthodontically is worried about teeth leveling and alignment. The accuracy of this procedure depends on various variables.
Friction is generated upon the materialistic composition of different bracket and archwire types, and the technique of ligature between them.
Several self-ligating brackets have been grown since 1935. Self-ligation doesn't need for an elastomeric attachment to catch the archwire, so it is related with a highly reduced friction with many different types of archwires, therefore less force required.
It is valuable to evaluate any appliance system for its capability to align teeth with minimal injurious effects to the oral tissues.
The aim of this study will be to compare labial alveolar bone thickness and apical root resorption changes associated with self-ligating versus conventional brackets.
Subjects and method
Study design:
Randomized controlled clinical trial
Study setting and population:
The sample of this study will be consisted of twenty one patients selected from Outpatient Clinic, Orthodontic Department, Faculty of Dentistry, Mansoura University.
Interventions:
The patients will be divided randomly into two groups and will be treated separately as follows:
- Group I: will be treated using passive self-ligating ceramic orthodontic brackets with stainless steel archwire slot liner.
- Group II: will be treated using conventional stainless steel orthodontic brackets ligated with elastomeric ligature.
The patients will be treated orthodontically within the initial leveling and alignment for the 6 month duration beginning with the same sequence of 0.014, 0.016, 0.016 × 0.022 inch nickel-titanium archwires and 0.016 × 0.022 inch stainless-steel archwire. Each archwire will be remained for 1.5 months, and it will be replaced with the previously mentioned sequence. For group II, the archwires will be attached to the brackets by using an elastomeric ligature. CBCT will be obtained in two time intervals, before beginning the orthodontic treatment and 6 months after it. Dental stripping and extraction of premolars will be eliminated.
Records:
For all patients the following records will be taken before and after leveling and alignment:
- Standardized upper and lower study casts.
- Standardized periapical radiograph.
- Standardized extra-oral and intra-oral photographs.
- Standardized cone beam computed tomography (CBCT).
Observations:
Sagittal cuts of upper and lower incisors in the center of the long axis will be selected. The labial alveolar bone thickness (LABT) of each incisor will be determined at the site neighboring to the widest point of the labiopalatal root in two levels separated by 3 mm (L1 and L2, respectively); these levels will be set along the long axis of the incisor and located every 3 mm from the cementoenamel junction (CEJ) level. Labial alveolar bone thickness will be assessed at the cervical level (L1) and midroot level (L2) at T0 and T1. Furthermore, the apical root resorption (ARR) will be calculated by determining the difference in the total tooth length, which will be measured in millimeters from the incisal border to the root apex, between T0 and T1 (T1-T0).
Ethical consideration:
All patients will receive information about the future clinical trial study and give their consent by signing an informed consent.
Data management and analysis: All statistical analysis will be performed with SPSS software. Differences will be considered significant at P values less than 0.05.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Device: Clarity SL MBT brackets; 3M Unitek, Monrovia, CA, USAwill be treated using passive self-ligating ceramic orthodontic brackets with stainless steel archwire slot liner (3M Unitek - USA). Intervention: Device: passive self-ligating ceramic orthodontic brackets with stainless steel archwire slot liner (3M Unitek - USA). |
| Group II | Experimental | Device: Gemini MBT brackets; 3M Unitek, Monrovia, CA, USAwill be treated using conventional stainless steel orthodontic brackets ligated with elastomeric ligature (3M Unitek - USA). Intervention: Device: conventional stainless steel orthodontic brackets ligated with elastomeric ligature (3M Unitek - USA). |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age ranged between 14-20 years.
- Complete permanent dentition (excluding third molars).
- Angle Class I malocclusion.
- Crowding anteriorly ranging from 2 to 4 mm.
- Healthy young patients.
Key exclusion criteria (5 listed)
- Patients with signs of apical root resorption detected at the first examination by periapical radiographs.
- Blocked-out or High-up canines.
- Patients who went to previous orthodontic treatment.
- Evidence of periodontal or gingival problems.
- Endodontic 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 |
|---|---|---|
| Clarity SL MBT brackets; 3M Unitek, Monrovia, CA, USAAlso: Clarity SL(passive self-ligating ceramic orthodontic brackets with stainless steel archwire slot liner) | Device | Group I |
| Gemini MBT brackets; 3M Unitek, Monrovia, CA, USAAlso: Gemini(conventional stainless steel orthodontic brackets ligated with elastomeric ligature) | Device | Group II |
Primary outcome
Labial alveolar bone thickness
Time frame: Change from baseline in Labial alveolar bone thickness at 6 months
Labial alveolar bone thickness will be measured in millimeters using CBCT at the site neighboring to the widest point of the labiopalatal root in two levels separated by 3 mm (L1 and L2, respectively); these levels were set along the long axis of the incisor and located every 3 mm from the cementoenamel junction (CEJ) level. Labial alveolar bone thickness was assessed at the cervical level (L1) and midroot level (L2) at T0 and T1.
Apical root resorption
Time frame: Change from baseline in Apical root resorption at 6 months
Apical root resorption will be measured in millimeters using CBCT by determining the difference in the total tooth length, which was measured from the incisal border to the root apex, between T0 and T1 (T1-T0).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
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Alveolar Bone Loss, Tooth Extraction Status Nos
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 Clarity SL MBT brackets; 3M Unitek, Monrovia, CA, USA and Gemini MBT brackets; 3M Unitek, Monrovia, CA, USA in people with Labial Alveolar Bone Thickness and Apical Root Resorption, run by Mansoura 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 5 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 28 Jun 2016. 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?
Contact Dr. Shaza M. Hammad, Associate Professor (00201014910066, shazamohammad@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Labial alveolar bone thickness (time frame: Change from baseline in Labial alveolar bone thickness at 6 months). The study lists 2 primary outcomes in all. 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 28 Jun 2016.