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Orthodontic ExtractionPremolarNCT07445321

Comparison of Rate and Amount of Orthodontic Space Closure

A study testing Space Closure in people with Orthodontic Extraction, run by Dow University of Health Sciences at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this clinical trial is to compare rate and amount of space closure among fresh vs healed extraction sites during fixed orthodontic treatment in patients with all first premolar's extraction Primary outcome measure is to calculate rate and amount of space closure between fresh vs healed as well as maxilla… Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Orthodontic Extraction
What is being tested?
Space Closure
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 sitePakistan
Study dates
15 Feb 2023to 9 Feb 2024
Phase
Interventional

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 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Patients aged 18-35 years.
  • Patients undergoing fixed appliance treatment.
  • Good oral hygiene and periodontal support.
  • Patients with all first premolar's extraction treatment plan.
  • Atraumatic extraction.

Who cannot join

  • History of previous orthodontic treatment
  • Systemic diseases like diabetes, hypertension etc
  • Any bone pathology or taking medicines like bisphosphonates
  • Patients with clefts or any syndromic condition.
  • Patients with old extraction socket.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Dr Ishrat ul Ebad Khan Institute of Oral Health Sciences

    Karachi, Sindh, 75300

Other trials in Pakistan

About this study

Official title: Comparison of Rate and Amount of Orthodontic Space Closure After All First Premolars Extraction in Healed vs Fresh Extraction Sites. A Randomized Clinical Trial.

The goal of this clinical trial is to compare rate and amount of space closure among fresh vs healed extraction sites during fixed orthodontic treatment in patients with all first premolar's extraction Primary outcome measure is to calculate rate and amount of space closure between fresh vs healed as well as maxilla and mandible.

Read the detailed description

The mandibular and maxillary arches of 34 patients will be included whose treatment plan decision was the extraction of all first premolars. Due to the split mouth approach, patients' maxillary and mandibular arches are randomly subdivided into two groups (right and left sides). First premolar extraction spaces in Group 1 will be closed once they have healed (6 week), while first premolar extraction spaces in Group 2 will be closed immediately after extraction. Both the upper and lower extraction spaces will be closed using coil springs (magnitude of force 30g per side). We'll specify the following time intervals: T1: Immediately prior to space closure; T2: 1 month after initial space closure; T3: 2 months after initial space closure T3: 3 months after initial space closure. Records will include measuring the rate and amount of space closure through Vernier calipers on dental cast as well as intraorally and will be evaluated at each time point.

Being tested
Space Closure
Keywords
Fixed Orthodontic Treatment, Fresh extraction socket, Healed extraction socket, premolar
Medical subject headings
Bicuspid Aortic Valve Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Space ClosureProcedure or surgery

    Also called Extraction

    Space Closure in fresh vs healed extraction socket

Study groups in NCT07445321
Study groupRoleWhat they receive
fresh vs healed extraction socketExperimentalComparison of rate and amount of space closure in fresh vs healed extraction socket
Receives: Procedure: Space Closure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To compare rate of space closure among fresh vs healed extraction sites during fixed orthodontic treatment in patients with all first premolar's extraction.

    This study will be useful in making the timely decision for extraction of premolars and estimation of orthodontic treatment duration as well.

    Measured: four time points are taken. T0: Baseline, T1: One month, T2: Two months, T3: Three months

Secondary outcomes (1)
  1. To compare amount of space closure among fresh vs healed extraction sites during fixed orthodontic treatment in patients with all first premolar's extraction.

    Total space closure

    Measured: Space closure at T3 is subtracted from T0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2026
  2. Study start15 Feb 2023
  3. Primary completion20 Dec 2023
  4. Study completion9 Feb 2024

Resources

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
Not applicable
Intervention model
Single group
Model description
Each patients mouth is splitted into four quadrants.Intervention is done either on left or right side randomly allocated
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07445321
Sponsor's protocol ID
BAnis
Acronym
Premolar
Status last verified
Feb 2026
First submitted
29 Jan 2026
Last updated
3 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no need to share individual participants data

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