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.
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
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.
- Conditions
- Orthodontic Extraction
- 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 group | Role | What they receive |
|---|---|---|
| fresh vs healed extraction socket | Experimental | Comparison 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.
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)
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.
- First posted3 Mar 2026
- Study start15 Feb 2023
- Primary completion20 Dec 2023
- Study completion9 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic ExtractionStudies 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
- 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)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sadia Rizwan, BDS, FCPS, CHPE, Study director, Dr Ishrat ul Ebad Khan Institute of Oral Health Sciences
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