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
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Shanzay Khan, BDS, Post Graduate Resident
- 전화번호: 03245555716
- 이메일: shanzaykhan1997@gmail.com
연구 장소
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Islamabad, 파키스탄, 44000
- 모병
- Shifa College Of Dentistry
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연락하다:
- Shanzay Khan
- 전화번호: 03245555716
- 이메일: shanzaykhan1997@gmail.com
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-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- History of dental trauma
- Poor oral hygiene
- Syndromic patients
- Systemic diseases or medications affecting bone metabolism
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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활성 비교기: Healed Socket Group (Control Group)
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.
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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.
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실험적: Unhealed Socket Group (Intervention Group)
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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Rate of Orthodontic Space Closure Measured on Digital 3D Dental Models
기간: Baseline (T0), 3 months (T1), and 6 months (T2) after initiation of en-masse anterior retraction
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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).
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Baseline (T0), 3 months (T1), and 6 months (T2) after initiation of en-masse anterior retraction
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence and Severity of Gingival Clefts Assessed Clinically Using a Periodontal Probe
기간: Baseline (T0), 3 months (T1), and 6 months (T2) after initiation of en-masse anterior retraction
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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.
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Baseline (T0), 3 months (T1), and 6 months (T2) after initiation of en-masse anterior retraction
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Linear Mesial Movement of Maxillary First Molars Measured on Digital Models
기간: Baseline (T0), 3 months (T1), and 6 months (T2) after initiation of en-masse anterior retraction
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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.
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Baseline (T0), 3 months (T1), and 6 months (T2) after initiation of en-masse anterior retraction
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Ease of Maxillary First Premolar Extraction Assessed by Surgeon-Rated 4-Point Likert Scale and Extraction Duration
기간: Periprocedural
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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.
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Periprocedural
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Patient-Reported Pain and Dental Anxiety Associated With Premolar Extraction
기간: Dental anxiety immediately before extraction; pain immediately following extraction.
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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.
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Dental anxiety immediately before extraction; pain immediately following extraction.
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 141-26
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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