Malocclusion Class IINCT07773389
Effect of Early Versus Late Premolar Extraction on Orthodontic Tooth Movement
A study testing Early Maxillary First Premolar Extraction and Late Maxillary First Premolar Extraction in people with Malocclusion Class II and Malocclusion, Angle Class I, run by Shifa College of Dentistry at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 25 years
- Conditions the study is for
- Malocclusion Class II, Malocclusion, Angle Class I
- What is being tested?
- Early Maxillary First Premolar Extraction and Late Maxillary First Premolar Extraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Jul 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- History of dental trauma
- Poor oral hygiene
- Syndromic patients
- Systemic diseases or medications affecting bone metabolism
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Shifa College Of Dentistry
Islamabad, 44000
Shanzay Khan, 03245555716, shanzaykhan1997@gmail.com
About this study
Official title: Effect of Early vs Late Premolar Extraction on the Rate of Orthodontic Tooth Movement: A Randomized Controlled Trial
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:
Read more
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.
Read the detailed description
This randomized controlled trial will evaluate the effect of early versus late maxillary first premolar extraction on the rate of orthodontic space closure during en-masse anterior retraction. A total of 26 participants aged 13 to 25 years requiring bilateral maxillary first premolar extractions as part of their orthodontic treatment will be randomly allocated in a 1:1 ratio to an early-extraction or late-extraction group.
In the early-extraction group, the maxillary first premolars will be extracted before or within one week of fixed appliance placement. Participants will subsequently undergo leveling and alignment, and en-masse anterior retraction will begin after stabilization on a 0.019 × 0.025-inch stainless steel archwire. In the late-extraction group, leveling and alignment will be completed first using the same archwire sequence. The maxillary first premolars will then be extracted immediately before initiation of en-masse anterior retraction. Thus, space closure will occur through relatively healed extraction sites in the early-extraction group and relatively fresh extraction sites in the late-extraction group.
Orthodontic space closure will be assessed at baseline and at 3 and 6 months after initiation of retraction. Secondary assessments will include mesial movement of the maxillary first molars, incidence and severity of gingival clefts, ease and duration of premolar extraction, and patient-reported pain and anxiety. Digital models will be used to assess orthodontic tooth movement, while gingival clefts will be evaluated clinically.
- Conditions
- Malocclusion Class II, Malocclusion, Angle Class I
- Being tested
- Early Maxillary First Premolar Extraction, Late Maxillary First Premolar Extraction
- Keywords
- Orthodontic Tooth movement, Premolar extraction, Early Extraction, Late Extraction, Orthodontic Space Closure, En-masse anterior retraction, Gingival Cleft, Anchorage loss
- Medical subject headings
- Malocclusion, Angle Class I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Maxillary First Premolar ExtractionProcedure or surgery
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.
Late Maxillary First Premolar ExtractionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Late Maxillary First Premolar Extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Gingival clefts will be assessed clinically using a periodontal probe.The presence, severity (depth and width in mm), and type (buccal, lingual, or through-and-through) of gingival clefts will be recorded. Cleft severity will be assessed by measuring depth and width in millimeters. Depth will be measured perpendicular to the occlusal plane, and the width will be measured parallel to the occlusal plane from the buccal and lingual aspect, with the greater of the two measurements recorded as the cleft width.
Measured: 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
Measurements will be performed on digital dental models obtained by intraoral scanning. Linear mesial movement of the maxillary first molars will be measured in millimeters. Perpendicular reference lines to the mid-palatal suture will be constructed through the mesial contact point of the maxillary first molar and the medial end of the third palatal rugae. The distance between these reference lines will be measured in millimeters. The change in this distance from baseline (T0) to 3 months (T1) and from baseline to 6 months (T2) will represent linear mesial movement.
Measured: 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
Surgeon-perceived ease of extraction will be assessed using a 4-point Likert scale: 1 = very easy, 2 = easy, 3 = difficult, and 4 = very difficult, with higher scores indicating greater extraction difficulty. Extraction duration will also be recorded from the time the forceps are clamped onto the tooth until the tooth is completely removed from the socket.
Measured: Periprocedural
Patient-Reported Pain and Dental Anxiety Associated With Premolar Extraction
Pain will be assessed using a 0-10 Visual Analogue Scale, where 0 represents no pain and 10 represents the worst pain. Dental anxiety will be assessed using a 5-item questionnaire, with each item rated from 1 (not anxious) to 5 (extremely anxious), giving a total score of 5-25. Higher scores indicate greater pain or anxiety.
Measured: Dental anxiety immediately before extraction; pain immediately following extraction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start22 Jul 2026
- Primary completionJan 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malocclusion Class IIStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shifa College of Dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shanzay Khan, Shifa College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773389
- Sponsor's protocol ID
- 141-26
- Status last verified
- Jul 2026
- First submitted
- 12 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early vs Late Premolar Extraction on the Rate of Orthodontic Tooth Movement: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07773389
- Acronym / sponsor ID
- 141-26
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Shifa College of DentistryUniversity, hospital or other
- Study start
- 22 Jul 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This randomized controlled trial will evaluate the effect of early versus late maxillary first premolar extraction on the rate of orthodontic space closure during en-masse anterior retraction. A total of 26 participants aged 13 to 25 years requiring bilateral maxillary first premolar extractions as part of their orthodontic treatment will be randomly allocated in a 1:1 ratio to an early-extraction or late-extraction group.
In the early-extraction group, the maxillary first premolars will be extracted before or within one week of fixed appliance placement. Participants will subsequently undergo leveling and alignment, and en-masse anterior retraction will begin after stabilization on a 0.019 × 0.025-inch stainless steel archwire. In the late-extraction group, leveling and alignment will be completed first using the same archwire sequence. The maxillary first premolars will then be extracted immediately before initiation of en-masse anterior retraction. Thus, space closure will occur through relatively healed extraction sites in the early-extraction group and relatively fresh extraction sites in the late-extraction group.
Orthodontic space closure will be assessed at baseline and at 3 and 6 months after initiation of retraction. Secondary assessments will include mesial movement of the maxillary first molars, incidence and severity of gingival clefts, ease and duration of premolar extraction, and patient-reported pain and anxiety. Digital models will be used to assess orthodontic tooth movement, while gingival clefts will be evaluated clinically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healed Socket Group (Control Group) | Active comparator | Procedure: Early Maxillary First Premolar ExtractionMaxillary 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. |
| Unhealed Socket Group (Intervention Group) | Experimental | Procedure: Late Maxillary First Premolar ExtractionMaxillary 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. |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- History of dental trauma
- Poor oral hygiene
- Syndromic patients
- Systemic diseases or medications affecting bone metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Maxillary First Premolar ExtractionBilateral 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. | Procedure or surgery | Healed Socket Group (Control Group) |
| Late Maxillary First Premolar ExtractionBilateral 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. | Procedure or surgery | Unhealed Socket Group (Intervention Group) |
Primary outcome
Rate of Orthodontic Space Closure Measured on Digital 3D Dental Models
Time frame: Baseline (T0), 3 months (T1), and 6 months (T2) after initiation of en-masse anterior retraction
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).
4 secondary outcomes
Incidence and Severity of Gingival Clefts Assessed Clinically Using a Periodontal Probe
Time frame: 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
Time frame: 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
Time frame: Periprocedural
Patient-Reported Pain and Dental Anxiety Associated With Premolar Extraction
Time frame: Dental anxiety immediately before extraction; pain immediately following extraction.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Maxillary First Premolar Extraction and Late Maxillary First Premolar Extraction in people with Malocclusion Class II and Malocclusion, Angle Class I, run by Shifa College of Dentistry at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shanzay Khan, BDS, Post Graduate Resident (03245555716, shanzaykhan1997@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Orthodontic Space Closure Measured on Digital 3D Dental Models (time frame: Baseline (T0), 3 months (T1), and 6 months (T2) after initiation of en-masse anterior retraction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.