Effect of Early Versus Late Premolar Extraction on Orthodontic Tooth Movement

NCT07773389 | Recruiting

• 1 other identifier: 141-26
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• Receive fixed orthodontic treatment and bilateral extraction of the maxillary first premolars.
• Be randomly assigned to either the early-extraction or late-extraction group.
• Undergo orthodontic alignment followed by en-masse anterior retraction.
• Have dental impressions/digital models obtained at the start of retraction and at 3 and 6 months to measure orthodontic tooth movement and space closure.
• Be assessed for gingival clefts and mesial movement of the upper first molars.
• Have the ease and duration of their premolar extraction recorded and report their pain and anxiety associated with the extraction procedure.

Conditions

Malocclusion Class II; Malocclusion, Angle Class I

Keywords

Orthodontic Tooth movement; Premolar extraction; Early Extraction; Late Extraction; Orthodontic Space Closure; En-masse anterior retraction; Gingival Cleft; Anchorage loss

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

• 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.

Study Arms (2)

Healed Socket Group (Control Group)

ACTIVE COMPARATOR

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.

Procedure: Early Maxillary First Premolar Extraction

Unhealed Socket Group (Intervention Group)

EXPERIMENTAL

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.

Procedure: Late Maxillary First Premolar Extraction

Interventions

Early Maxillary First Premolar Extraction PROCEDURE

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.

Healed Socket Group (Control Group)

Late Maxillary First Premolar Extraction PROCEDURE

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.

Unhealed Socket Group (Intervention Group)

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 13-25 years
• No prior orthodontic treatment
• Overjet 4-8 mm
• Symmetric dental arches with mild to moderate crowding requiring bilateral first premolar extractions.
• Probing depth less than 4 mm on all teeth

You may not qualify if:

• History of dental trauma
• Poor oral hygiene
• Syndromic patients
• Systemic diseases or medications affecting bone metabolism

Sponsors & Collaborators

• Shifa College of Dentistry: lead

Study Sites (1)

Shifa College Of Dentistry

Islamabad, 44000, Pakistan

RECRUITING

MeSH Terms

Conditions

Malocclusion, Angle Class I

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Shanzay Khan, BDS, Post Graduate Resident

CONTACT

03245555716; shanzaykhan1997@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and the data analyst will be blinded to group allocation. Participants and treating clinicians will not be blinded due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Resident in Orthodontics

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 19, 2026
• Study Start: July 22, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 19, 2026

Record last verified: 2026-07

Locations

PA (1)