NCT07773389|Recruiting
Effect of Early Versus Late Premolar Extraction on Orthodontic Tooth Movement
Effect of Early vs Late Premolar Extraction on the Rate of Orthodontic Tooth Movement: A Randomized Controlled Trial
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Effect of Early vs Late Premolar Extraction on the Rate of Orthodontic Tooth Movement: A Randomized Controlled Trial
Sponsor study identifier
interventional
26
1 country
1
Study Start
July 22, 2026
Actual (reported)Primary Completion
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The goal of this randomized controlled trial is to evaluate whether the timing of premolar extraction affects the rate of orthodontic space closure during en-masse anterior retraction. The study will also assess gingival cleft formation, mesial movement of the upper first molars, ease and duration of premolar extraction, and patient-reported pain and anxiety. The main question it aims to answer is: Does early versus late premolar extraction affect the rate of orthodontic space closure? Researchers will compare two groups of patients. In the early extraction group the maxillary first premolars will be extracted before or within one week of start of fixed orthodontic treatment. In the late extraction group, the premolars will be extracted after alignment and immediately before the start of space closure. Participants will:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 22, 2026
Actual (reported)August 12, 2026
Actual (reported)August 19, 2026
Actual (reported)January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Rate of Orthodontic Space Closure Measured on Digital 3D Dental Models
Intraoral scans will be obtained to generate digital 3D dental models at baseline (T0), 3 months (T1), and 6 months (T2) after initiation of en-masse anterior retraction. The extraction space will be measured in millimeters as the linear distance between the highest convexity on the mesial surface of the maxillary second premolar and the distal surface of the maxillary canine. The rate of space closure will be calculated as the reduction in extraction-space width over the corresponding observation period and expressed in millimeters per month (mm/month).
Baseline (T0), 3 months (T1), and 6 months (T2) after initiation of en-masse anterior retraction
Incidence and Severity of Gingival Clefts Assessed Clinically Using a Periodontal Probe
Baseline (T0), 3 months (T1), and 6 months (T2) after initiation of en-masse anterior retraction
Maxillary first premolars will be extracted before or within one week of fixed orthodontic appliance placement. Participants will subsequetly undergo leveling and alignment followed by en-masse anterior retraction after stabilization on a 0.019 x 0.025-inch stainless steel archwire.
Maxillary first premolars will be extracted after the participant has completed leveling and alignment, and has been stabilizad on a 0.019 x 0.025-inch stainless steel archwire for one month. This will be followed immediately by en-masse anterior retraction.
Bilateral extraction of the maxillary first premolars will be performed prior to or within one week of fixed orthodontic appliance placement, allowing the extraction sockets to heal during leveling and alignment before commencement of en-masse anterior retraction.
Bilateral extraction of the maxillary first premolars will be performed after completion of leveling and alignment and one month of stabilization on a 0.019 × 0.025-inch stainless steel archwire, immediately before commencement of en-masse anterior retraction.
Shifa College Of Dentistry
Islamabad, 44000, Pakistan
First Submitted
August 12, 2026
First Posted
August 19, 2026
Study Start
July 22, 2026
Actual (reported)Primary Completion
Linear Mesial Movement of Maxillary First Molars Measured on Digital Models
Baseline (T0), 3 months (T1), and 6 months (T2) after initiation of en-masse anterior retraction
Ease of Maxillary First Premolar Extraction Assessed by Surgeon-Rated 4-Point Likert Scale and Extraction Duration
Periprocedural
Patient-Reported Pain and Dental Anxiety Associated With Premolar Extraction
Dental anxiety immediately before extraction; pain immediately following extraction.
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Contact the study team to confirm eligibility.
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 19, 2026
Record last verified: 2026-07
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Source: ClinicalTrials.gov.
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