Comparison of Acupressure, Ibuprofen, and Chewing Gum for the Management of Post-Archwire Orthodontic Pain
Comparative Efficacy of Acupressure, Ibuprofen, and Chewing Gum in Managing Post-Archwire Orthodontic Pain: A Three-Arm Randomized Clinical Trial
The goal of this clinical trial is to find out which method works best to reduce pain after braces are adjusted for the first time (when the first archwire is placed). The study will compare three approaches: acupressure (applying pressure on a specific point on the hand), ibuprofen (a pain-relief medicine), and chewing sugar-free gum. It will also check how safe these methods are and whether patients need extra pain medicine.
The main questions the researchers want to answer are:
Which method reduces orthodontic pain the most after the first archwire is placed? Do patients need extra painkillers in any of the groups? Are there any problems with braces (such as loose brackets or wire issues) within the first week?
Researchers will compare the three groups to see which option gives the best pain relief during the first few days after braces are activated.
Participants will:
Be placed into one of three groups: acupressure, ibuprofen, or chewing gum Use their assigned method after their first orthodontic wire is placed Rate their pain at different time points using a simple pain scale (VAS) Report if they take any extra pain medicine Be checked for any brace-related problems for up to 7 days
This study may help improve comfort and pain management for patients starting orthodontic treatment.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
参加基準
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 15 to 35 years
- Complete permanent dentition
- Undergoing comprehensive fixed orthodontic treatment
- Scheduled for initial archwire placement
- Ability to comply with study procedures
- Written informed consent provided (or parental/guardian consent for participants younger than 18 years)
Exclusion Criteria:
- Pregnant or lactating
- Systemic disorders that may affect pain perception
- Periodontal disease
- Neurological abnormalities that may affect pain perception
- Known sensitivity to chewing gum
- Documented allergy to ibuprofen
- Use of adjunctive orthodontic appliances
- Use of analgesics, anti-inflammatory medications, or other medications that may affect pain perception within 24 hours before enrollment
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
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Acupressure Intervention
Participants in this arm will receive instructions on the use of acupressure for orthodontic pain management following placement of the initial archwire.
Verbal instructions and a standardized advice sheet will be provided.
Participants will be trained to apply steady, perpendicular pressure using the thumb of the opposite hand to the LI4 (Hegu) acupressure point for approximately 3 minutes.
The location of the LI4 point will be demonstrated and identified as the point on the dorsum of the hand between the first and second metacarpal bones, at the midpoint of the second metacarpal bone near its radial border.
Participants will be instructed to perform acupressure according to the standardized study protocol.
|
Participants in this arm will receive instructions on the use of acupressure for orthodontic pain management following placement of the initial archwire.
Verbal instructions and a standardized advice sheet will be provided.
Participants will be trained to apply steady, perpendicular pressure using the thumb of the opposite hand to the LI4 (Hegu) acupressure point for approximately 3 minutes.
The location of the LI4 point will be demonstrated and identified as the point on the dorsum of the hand between the first and second metacarpal bones, at the midpoint of the second metacarpal bone near its radial border.
Participants will be instructed to perform acupressure according to the standardized study protocol.
他の名前：
|
|
アクティブコンパレータ：Ibuprofen Intervention
In the ibuprofen group participants will be provided with a 400 mg oral dose post arch wire placement.
With a minimum gap of 8 hours between doses, remaining doses will be taken as per need for the relief of pain with the total daily dose not surpassing 1200 mg.
|
In the ibuprofen group participants will be provided with a 400 mg oral dose post arch wire placement.
With a minimum gap of 8 hours between doses, remaining doses will be taken as per need for the relief of pain with the total daily dose not surpassing 1200 mg.
|
|
実験的：Chewing Gum Intervention
Instructions to chew sugar-free gum for a period of 10 minutes immediately post arch wire placement will be provided to the chewing gum group, 8 hourly, for pain relief.
|
Instructions to chew sugar-free gum for a period of 10 minutes immediately post arch wire placement will be provided to the chewing gum group, 8 hourly, for pain relief.
|
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 |
|---|---|---|
|
Post-archwire orthodontic pain
時間枠：Pain levels will be recorded using a 10-cm visual analog scale (vas) at the following intervals: • 2 hours • 6 hours • Bedtime (day 1) • 24 hours (day 2) • Day 3 • Day 7
|
Pain experienced by patients following placement of the initial orthodontic archwire, measured using the Visual Analog Scale (VAS).
|
Pain levels will be recorded using a 10-cm visual analog scale (vas) at the following intervals: • 2 hours • 6 hours • Bedtime (day 1) • 24 hours (day 2) • Day 3 • Day 7
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Rescue analgesic consumption
時間枠：Within 7 days following initial archwire placement.
|
Use of any additional analgesic medication beyond the assigned intervention.
|
Within 7 days following initial archwire placement.
|
|
Appliance-related complications
時間枠：Within 7 days following initial archwire placement.
|
Mechanical issues occurring such as bracket debonding or wire displacement.
|
Within 7 days following initial archwire placement.
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- BUHS-IRB#264/26
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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