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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Shanzay Khan, BDS, Post Graduate Resident
- 電話番号：03245555716
- メール：shanzaykhan1997@gmail.com
研究場所
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-
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Islamabad、パキスタン、44000
- 募集
- Shifa College Of Dentistry
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コンタクト：
- Shanzay Khan
- 電話番号：03245555716
- メール：shanzaykhan1997@gmail.com
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-
参加基準
適格基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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アクティブコンパレータ：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.
|
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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実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Rate of Orthodontic Space Closure Measured on Digital 3D Dental Models
時間枠：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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二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence and Severity of Gingival Clefts Assessed Clinically Using a Periodontal Probe
時間枠：Baseline (T0), 3 months (T1), and 6 months (T2) after initiation of en-masse anterior retraction
|
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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- 141-26
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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