- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07445321
Comparison of Rate and Amount of Orthodontic Space Closure (Premolar)
February 28, 2026 updated by: Dow University of Health Sciences
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan, 75300
- Dr Ishrat ul Ebad Khan Institute of Oral Health Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: fresh vs healed extraction socket
Comparison of rate and amount of space closure in fresh vs healed extraction socket
|
Space Closure in fresh vs healed extraction socket
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To compare rate of space closure among fresh vs healed extraction sites during fixed orthodontic treatment in patients with all first premolar's extraction.
Time Frame: four time points are taken. T0: Baseline, T1: One month, T2: Two months, T3: Three months
|
This study will be useful in making the timely decision for extraction of premolars and estimation of orthodontic treatment duration as well.
|
four time points are taken. T0: Baseline, T1: One month, T2: Two months, T3: Three months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To compare amount of space closure among fresh vs healed extraction sites during fixed orthodontic treatment in patients with all first premolar's extraction.
Time Frame: Space closure at T3 is subtracted from T0
|
Total space closure
|
Space closure at T3 is subtracted from T0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Sadia Rizwan, BDS, FCPS, CHPE, Dr Ishrat ul Ebad Khan Institute of Oral Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 15, 2023
Primary Completion (Actual)
December 20, 2023
Study Completion (Actual)
February 9, 2024
Study Registration Dates
First Submitted
January 29, 2026
First Submitted That Met QC Criteria
February 28, 2026
First Posted (Actual)
March 3, 2026
Study Record Updates
Last Update Posted (Actual)
March 3, 2026
Last Update Submitted That Met QC Criteria
February 28, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Aortic Valve Disease
- Cardiovascular Diseases
- Heart Diseases
- Heart Valve Diseases
- Congenital Abnormalities
- Cardiovascular Abnormalities
- Heart Defects, Congenital
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Bicuspid Aortic Valve Disease
- Dentistry
- Orthodontics
- Orthodontics, Corrective
- Orthodontic Space Closure
Other Study ID Numbers
- BAnis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no need to share individual participants data
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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