Effect of Micro-osteo-perforations on the Rate of Alignment of Mandibular Anterior Teeth.
調査の概要
詳細な説明
MATERIAL AND METHODS:
STUDY DESIGN: Two parallel arm randomized controlled clinical trial SETTING: Orthodontics Department, Rehman College of Dentistry. DURATION OF STUDY: one year SAMPLING TECHNIQUE: non-probability consecutive sampling.
SAMPLE SELECTION:
INCLUSION CRITERIA
- Malocclusion cases with mandibular anterior segment crowding.
- Age range 13-30 years.
EXCLUSION CRITERIA:
- Missing lower anterior tooth.
- Systemic diseases/Medications affecting bone biology.
- Previous orthodontic treatment.
- Poor oral hygiene status.
- Active periodontal disease
- Syndromes. DATA COLLECTION Written informed consent from the patients will be taken after clarification of the purpose of the intervention and the associated risks and benefits. Orthodontic treatment will be started in all subjects using fixed preadusted edgewise appliance (0.022-in MBT prescription, Ortho Organizers, Inc. USA). After bonding of lower arch the patients will be randomized into control and experimental groups.
Patients will be randomly allocated, through computer generated tables in Microsoft Excel Software, into parallel groups with a 1:1 allocation ratio. Allocation will be concealed in opaque envelopes and opened only at the time of intervention.
Local anesthesia will be given in lower arch on each side approximately 1cm from labial frenum. Two points for screw insertion will be demarcated on buccal mucosa, in each interdental segment, by bleeding points using a calibrated periodontal probe. Probe tip will be inserted to the level of bone to measure the thickness of gingiva. The measurement will be added to the depth of perforation needed i-e 2 - 3 mm into the bone. First point will be marked at a distance of 3mm from free gingival margin and second point will be marked 3mm from the first one. Orthodontic miniscrew (AbsoAnchor, Korea) of 1.3 mm diameter will be used for MOPs to the depth of 2-3 mm into the buccal cortical bone. An endodontic rubber stopper will be set for required / optimal depth on miniscrew and MOPs will be performed. After the intervention, the patients will be instructed for maintaining good oral hygiene and to take analgesics, such as acetaminophen, only if necessary.
The control group will receive no MOPs at the alignment stage. Alignment will be started in both control and experimental groups using 0.012 NiTi (North American Braces, USA). Both the groups will be followed every month for maximum six months. Digital scan of lower arch will be taken on each visit. Each scan will be labelled for identification, date of scan taking and little index score .For reliability 20 randomly selected scan will be rescored for little index by the same examiner as well as another examiner after 2 weeks for intra and inter-examiner reliability.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Shahida Jehan, BDS
- 電話番号:03438901267
- メール:shahida.jehan@rmi.edu.pk
研究連絡先のバックアップ
- 名前:Sohrab Shaheed, FCPS
- 電話番号:03339327608
- メール:sohrab.shaheed@rmi.edu.pk
研究場所
-
-
KPK
-
Peshawar、KPK、パキスタン、25100
- 募集
- Sohrab Shaheed
-
コンタクト:
- Sohrab Shaheed, FCPS
- 電話番号:03339327608
- メール:sohrab.shaheed@rmi.edu.pk
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Malocclusion cases with mandibular anterior segment crowding.
- Age range 13-30 years.
Exclusion Criteria:
- Missing lower anterior tooth.
- Systemic diseases/Medications affecting bone biology.
- Previous orthodontic treatment.
- Poor oral hygiene status.
- Active periodontal disease
- Syndromes
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:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:MOPs group
Orthodontic treatment will be started in all subjects using fixed preadusted edgewise appliance (0.022-in MBT prescription, Ortho Organizers, Inc. USA).Local anesthesia will be given in lower arch .Two points for screw insertion will be demarcated on buccal mucosa, in each interdental segment using a calibrated periodontal probe.
Orthodontic miniscrew (AbsoAnchor, Korea) of 1.3 mm diameter will be used for MOPs to the depth of 2-3 mm into the buccal cortical bone.
An endodontic rubber stopper will be set for required / optimal depth on miniscrew and MOPs will be performed.
After the intervention, the patients will be instructed for maintaining good oral hygiene and to take analgesics, such as acetaminophen, only if necessary.
|
2 inter radicular bone microosteoperforations using temporary anchorage device tip.
|
|
介入なし:Control group
Orthodontic treatment will be started in all subjects using fixed preadusted edgewise appliance (0.022-in MBT prescription, Ortho Organizers, Inc. USA).The control group will receive no MOPs at the alignment stage.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Rate of alignment of lower anterior teeth
時間枠:6 months
|
Rate of alignment of lower anterior teeth
|
6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
clinical crown length
時間枠:6 moths
|
clinical crown length
|
6 moths
|
協力者と研究者
捜査官
- スタディディレクター:Muhammad K Asif, PhD、Rehman Medical Institute
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
詳しくは
本研究に関する用語
その他の研究ID番号
- EC : 2021-06-070
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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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