Root ResorptionNCT03613285
A Comparative CT Evaluation of the Amount of Root Resorption in Self-ligating Versus Conventional Brackets
A study testing conventional brackets, smart clip passive self ligating brackets and Empower active self ligating brackets in people with Root Resorption, run by Institute of Dental Science and Technologies at 1 site in India.
Trial summary
Aim: The aim of the study was to evaluate and compare the extent of root resorption in the maxillary and mandibular anterior teeth during orthodontic treatment with the use of different types of brackets. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Root Resorption
- What is being tested?
- conventional brackets, smart clip passive self ligating brackets and Empower active self ligating brackets
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteIndia
- Study dates
- 1 Oct 2013to 1 Dec 2015
- 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 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients having complete root formation at start of treatment,
Who cannot join
- Patients with skeletal or dental anomalies .
- Patients having history of root resorption
- Patients having any systemic or metabolic anomalies,
- Patients with trauma of anterior teeth
- Patients with periapical inflammation of the anterior teeth
- Patients with impacted teeth
- Patients with tumors and cysts in the examined area
- Patients having undergone orthodontic treatment previously.
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Dental Studies & Technologies
Ghaziabad, Uttar Pradesh, 201201
About this study
Aim: The aim of the study was to evaluate and compare the extent of root resorption in the maxillary and mandibular anterior teeth during orthodontic treatment with the use of different types of brackets. Materials and methods: The study consisted of 21 patients (11 males and 10 females) within the age group of 16-25 years, having bimaxillary protrusion. They were divided into three groups. In Group 1- Conventional brackets, Group 2- Self-ligation brackets:Smart Clip (Passive), and in Group 3 Self-ligation brackets: Empower (Active) were bonded. Computed Tomography scans and Orthopantomograms were taken before start of treatment and after six months of retraction. Root resorption is computed as the difference between the pre treatment total tooth length and the post treatment total tooth length.
- Conditions
- Root Resorption
- Being tested
- conventional brackets, smart clip passive self ligating brackets, Empower active self ligating brackets
- Medical subject headings
- Root Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional bracketsDevice
conventional brackets with MBT prescription was used for orthodontic treatment and root resorption was assessed.
smart clip passive self ligating bracketsDevice
smart clip passive self ligating brackets with MBT prescription was used for orthodontic treatment and root resorption was assessed.
Empower active self ligating bracketsDevice
Empower active self ligating brackets with MBT prescription was used for orthodontic treatment and root resorption was assessed.
| Study group | Role | What they receive |
|---|---|---|
| conventional brackets | Active comparator | Conventional brackets with Mac Laughin bennette Trevisi (MBT) prescription Receives: Device: conventional brackets |
| Smart clip passive self ligating brackets | Active comparator | Smart clip passive self ligating brackets with Mac Laughin bennette Trevisi (MBT) prescription Receives: Device: smart clip passive self ligating brackets |
| Empower active self ligating brackets | Active comparator | Empower active self ligating brackets with Mac Laughin bennette Trevisi (MBT) prescription Receives: Device: Empower active self ligating brackets |
What is being measured
The primary outcome is the main question the study is designed to answer.
root resorption
Computed Tomography scans were taken before start of treatment and after six months of retraction.
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 posted3 Aug 2018
- Study start1 Oct 2013
- Primary completion1 Nov 2015
- Study completion1 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root ResorptionStudies 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
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Dental Science and Technologies
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehana Bashir, Institute of Dental Science and Technologies
- Investigators
- Puneet Batra, MDS, Study chair, IDST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613285
- Sponsor's protocol ID
- IDST/ERBC/2013/09
- Status last verified
- Jul 2018
- First submitted
- 15 Jul 2018
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will decide on case by case basis and as if our institution allows so
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative CT Evaluation of the Amount of Root Resorption in Self-ligating Versus Conventional Brackets
- ClinicalTrials.gov ID
- NCT03613285
- Acronym / sponsor ID
- IDST/ERBC/2013/09
- Conditions
- Root Resorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Institute of Dental Science and TechnologiesUniversity, hospital or other
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 1 Nov 2015 (actual)
- Study completion
- 1 Dec 2015 (actual)
- First posted
- 3 Aug 2018 (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.
Aim: The aim of the study was to evaluate and compare the extent of root resorption in the maxillary and mandibular anterior teeth during orthodontic treatment with the use of different types of brackets. Materials and methods: The study consisted of 21 patients (11 males and 10 females) within the age group of 16-25 years, having bimaxillary protrusion. They were divided into three groups. In Group 1- Conventional brackets, Group 2- Self-ligation brackets:Smart Clip (Passive), and in Group 3 Self-ligation brackets: Empower (Active) were bonded. Computed Tomography scans and Orthopantomograms were taken before start of treatment and after six months of retraction. Root resorption is computed as the difference between the pre treatment total tooth length and the post treatment total tooth length.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conventional brackets | Active comparator | Device: conventional bracketsConventional brackets with Mac Laughin bennette Trevisi (MBT) prescription |
| Smart clip passive self ligating brackets | Active comparator | Device: smart clip passive self ligating bracketsSmart clip passive self ligating brackets with Mac Laughin bennette Trevisi (MBT) prescription |
| Empower active self ligating brackets | Active comparator | Device: Empower active self ligating bracketsEmpower active self ligating brackets with Mac Laughin bennette Trevisi (MBT) prescription |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients having complete root formation at start of treatment,
Key exclusion criteria (8 listed)
- Patients with skeletal or dental anomalies .
- Patients having history of root resorption
- Patients having any systemic or metabolic anomalies,
- Patients with trauma of anterior teeth
- Patients with periapical inflammation of the anterior 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 |
|---|---|---|
| conventional bracketsconventional brackets with MBT prescription was used for orthodontic treatment and root resorption was assessed. | Device | conventional brackets |
| smart clip passive self ligating bracketssmart clip passive self ligating brackets with MBT prescription was used for orthodontic treatment and root resorption was assessed. | Device | Smart clip passive self ligating brackets |
| Empower active self ligating bracketsEmpower active self ligating brackets with MBT prescription was used for orthodontic treatment and root resorption was assessed. | Device | Empower active self ligating brackets |
Primary outcome
root resorption
Time frame: 6 months
Computed Tomography scans were taken before start of treatment and after six months of retraction.
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 3 Aug 2018.
- Individual participant dataSharing planned: Undecided. Will decide on case by case basis and as if our institution allows so
Related trials for Root Resorption
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Recruiting
3-D Evaluation of Alveolar Bone Changes and Root Resorption After Traction of Buccally Displaced Maxillary Canines
Malocclusion; Displaced Teeth
RecruitingObservational study
Clinical Investigation Measuring the Long Term Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications.
Dental Restoration, Permanent, Dental Restorations
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Maxillary Incisor Intrusion Using Utility Arch Assisted With Micro-osteoperforations
Deep Bite Malocclusion, Intrusion of Tooth
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.
Puneet Batra, MDS study chair
IDST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional brackets, smart clip passive self ligating brackets and Empower active self ligating brackets in people with Root Resorption, run by Institute of Dental Science and Technologies at 1 site in India.
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 1 inclusion and 8 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 3 Aug 2018. 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 India. 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?
root resorption (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 3 Aug 2018.