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CompletedNCT03613285Updated Aug 3, 2018

A Comparative CT Evaluation of the Amount of Root Resorption in Self-ligating Versus Conventional Brackets

An interventional study of conventional brackets and smart clip passive self ligating brackets in Root Resorption, sponsored by Institute of Dental Science and Technologies. Completed at 1 site in India. Open to participants aged 16 Years to 25 Years. Per ClinicalTrials.gov, last updated 2018-08-03.

Sponsored by Institute of Dental Science and Technologies · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 9 months after the study started (first participant enrolled Oct 2013, registered Jul 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
16 Years to 25 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Root Resorption

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03

In context

Root Resorption

43 studies on the registry are indexed under Root Resorption; 9 are open to participants now.

This study's enrollment of 21 is below the median of 29 across 36 interventional studies indexed under Root Resorption.

Browse Root Resorption studies →

Lead sponsor

This is the only study on the registry with Institute of Dental Science and Technologies as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients having complete root formation at start of treatment,

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Active comparator
    conventional brackets

    Conventional brackets with Mac Laughin bennette Trevisi (MBT) prescription

    Device: conventional brackets

  • Active comparator
    Smart clip passive self ligating brackets

    Smart clip passive self ligating brackets with Mac Laughin bennette Trevisi (MBT) prescription

    Device: smart clip passive self ligating brackets

  • Active comparator
    Empower active self ligating brackets

    Empower active self ligating brackets with Mac Laughin bennette Trevisi (MBT) prescription

    Device: Empower active self ligating brackets

Interventions

  • Deviceconventional brackets

    conventional brackets with MBT prescription was used for orthodontic treatment and root resorption was assessed.

  • Devicesmart clip passive self ligating brackets

    smart clip passive self ligating brackets with MBT prescription was used for orthodontic treatment and root resorption was assessed.

  • DeviceEmpower active self ligating brackets

    Empower active self ligating brackets with MBT prescription was used for orthodontic treatment and root resorption was assessed.

06

What researchers measure

Primary outcomes

  1. root resorption

    Computed Tomography scans were taken before start of treatment and after six months of retraction.

    Time frame: 6 months

07

Study locations

1 site
  • Institute of Dental Studies & Technologies
    Ghāziābād, Uttar Pradesh 201201, India
08

References and documents

Individual participant data

Plan to share: Undecided — Will decide on case by case basis and as if our institution allows so

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2013 to primary completion in Nov 2015, 25 months.

Of 25 interventional studies with no phase under Root Resorption, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 41. This study's 25 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 15, 2018
First posted
Aug 3, 2018
StartActual
Oct 1, 2013
Primary completionActual
Nov 1, 2015
CompletionActual
Dec 1, 2015
Last update
Aug 3, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03613285
Lead sponsor
Institute of Dental Science and Technologies
Responsible party
Rehana Bashir (Principal Investigator, Institute of Dental Science and Technologies) — Principal investigator
First posted
Aug 3, 2018
Start date
Oct 1, 2013
Primary completion
Nov 1, 2015
Completion
Dec 1, 2015
Last update
Aug 3, 2018

Study contacts

Puneet Batra, MDS
study chair · IDST

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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