Effect of Early Versus Late Premolar Extraction on Orthodontic Tooth Movement
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-25
SponsorShifa College of Dentistry
About this 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:
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
History of dental trauma
Poor oral hygiene
Syndromic patients
Systemic diseases or medications affecting bone metabolism
Trial design
Design model
Parallel
Treatments tested in this trial
Early Maxillary First Premolar Extraction
Procedure/SurgeryBilateral 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 Extraction
Procedure/SurgeryBilateral 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.
Treatment groups
26 Participants
are divided into 2 treatment groupsGroup A: Healed Socket Group (Control Group)Active comparator 1 intervention
Group B: Unhealed Socket Group (Intervention Group)Experimental treatment 1 intervention
Trial outcomes
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).
Time frame
Baseline (T0), 3 months (T1), and 6 months (T2) after initiation of en-masse anterior retractionSecondary outcomes
1
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.
Time frame
Baseline (T0), 3 months (T1), and 6 months (T2) after initiation of en-masse anterior retraction2
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.
Time frame
Baseline (T0), 3 months (T1), and 6 months (T2) after initiation of en-masse anterior retraction3
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.
Time frame
Periprocedural4
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.
Time frame
Dental anxiety immediately before extraction; pain immediately following extraction.Sponsors and contacts
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Source ClinicalTrials.gov