Effectiveness of Er:YAG Pulse Therapy for Achieving Pre-emptive Dental Analgesia in Children
A Split-mouth Clinical Study on the Effectiveness of Er:YAG Pulse Therapy for Achieving Pre-emptive Dental Analgesia in Children
The aim of this study is to determine the effectiveness of Er:YAG pulse therapy for achieving pulpal analgesia in pediatric patients and to quantify the duration and extent of any effects assessed.
Design: a randomized split-mouth study with two-way repeated measures design.
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
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- 適用できない
連絡先と場所
研究場所
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Plovdiv、ブルガリア、4000
- Department of Pediatric Dentistry, Faculty of Dental Medicine
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参加基準
適格基準
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
Exclusion criteria:
- Children who are considered medically compromised or medically complex patients. The absence of disease is confirmed by anamnestic interview with a parent or a care-giver of the child and excludes general acute or chronic disease, cognitive impairment, psychogenic nonepileptic events, radiotherapy in the maxillofacial region due to malignant process.
- Patients who are undergoing therapy with neurological, sedative, analgesic and/or anti-inflammatory drugs 7 days prior to treatment.
- Children, who are first time ever dental patients.
Inclusion criteria:
- Patients, identified as positive or definitely positive through Frankl behavioral rating scale.
- Patients who are not undergoing treatment or have been treated 6 months prior to inclusion with remineralizing agents.
- Patients, requiring conservative treatment of occlusal, caries on foramen caecum, and/or proximal caries on two first permanent upper jaw molars without prior restorations or dental sealants. Lesions are to be classified as moderate caries by the International caries detection and assessment system (ICDAS) with code 03 or code 04, which do not present spontaneous unprovoked pain, percussion or palpation pain or other symptoms, indicating of pulpal pathology. Included are carious lesions only on vital teeth, involving up to half of the dentine thickness, with no periodontal pathology. Laser fluorescence diagnosis of adjacent lesions with DIAGNODENT is limited to 20 - 35 scores included.
- Included are first molars which are not affected by hypoplasia or hypomineralization.
Obtained informed consent from parents or gave-givers to participate in the study, in which laser treatment and study procedures are explained in appropriate manner.
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:クロスオーバー割り当て
- マスキング:ダブル
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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実験的:Laser analgesia
Procedure: Laser analgesic procedure Performing protocol for pre-emptive laser analgesia with Er:YAG laser (Litetouch, Syneron) switched on.
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Water mist spray set to "maximum", non-contact handpiece with sapphire tip.
Tip-to-tissue distance 10 mm from the tooth neck, achieved by using a spacer.
Energy is delivered to the enamel above the gingival margin adjacent to the cemento-enamel junction (perpendicularly towards the dental pulp) on each of the four line angles of the tooth for 30s, moving the laser handpiece in a sweeping action.
Pulse energy - 0.2 W/ 10 Hz/ 20 mJ.
Follows increase of energy and repetition of protocol - 0.6 W/ 15 Hz/ 40 mJ.
Total duration of LA-induction - 240s.
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プラセボコンパレーター:Placebo analgesia
Procedure: Placebo analgesic procedure Performing imitation of laser analgesic protocol with Er:YAG laser (Litetouch, Syneron) switched off - no pulse energy applied.
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Performing imitation of laser analgesic procedure.
No pulse energy applied, non-contact handpiece with sapphire tip.
Moving the laser handpiece in a sweeping action towards the cemento-enamel junction (pointing perpendicularly towards the dental pulp) on each of the four line angles of the tooth.
Total duration of placebo analgesia induction - 240s.
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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 |
|---|---|---|
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Pain felt during treatment according to a visual analogue scale
時間枠:1 hour
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Reported by the patient at the end of the dental treatment session on a VAS (visual analogue scale), which contains a combination of Numeric Rating Scale (0-10, where 0 means no pain, 10 - worst possible pain) and Wong-Baker Faces Pain Scale, which includes pictures of facial expressions with correlating numbers of 0-10 (0 being 'no hurt' and 10 being 'hurts worst').
The combination allows children to pick a facial expression, that corresponds with their pain and see a number that matches it.
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1 hour
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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 |
|---|---|---|
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Changes in pulpal sensibility to electrical stimuli by electrical pulp tester
時間枠:25 minutes
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Evaluated via electrical pulp tester (EPT) 5 minutes before and on the 5th and 20th minute after laser/placebo analgesic procedure.
EPT result is a number.
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25 minutes
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Changes in pulpal sensibility to cold-stimuli by a visual analogue scale
時間枠:25 minutes
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Cold-test is applied 4 minutes before and on the 6th and 21st minute after laser/placebo analgesia.
Pain is reported by the patient on a VAS (visual analogue scale), which contains a combination of Numeric Rating Scale (0-10, where 0 means no pain, 10 - worst possible pain) and Wong-Baker Faces Pain Scale, which includes pictures of facial expressions with correlating numbers of 0-10 (0 being 'no hurt' and 10 being 'hurts worst').
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25 minutes
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Patient experience during analgesic or placebo procedure
時間枠:5 minutes
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evaluated by a patient questionnaire
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5 minutes
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Pain related behavior evaluated by the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale
時間枠:1 hour
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Evaluated by the outcomes assessor.
The FLACC scale has five criteria - Faces, Legs, Activity, Cry, Consolability, which are each assigned a score of 0, 1 or 2. Total score of scale is summed in range 0 to 10, where: 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain.
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1 hour
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Dynamics of the heart rate of the patient
時間枠:1 hour
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registered throughout the experiment via pulse oximeter
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1 hour
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Need for local anesthesia infiltration during the treatment
時間枠:1 hour
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Registered with 1=no; 2=yes.
Patients who request that the procedure is terminated to administer an anesthetic injection, are asked to rate their level of pain, according to aforementioned visual analogue scale, immediately following termination.
The visual analogue scale contains a combination of Numeric Rating Scale (0-10, where 0 means no pain, 10 - worst possible pain) and Wong-Baker Faces Pain Scale, which includes pictures of facial expressions with correlating numbers of 0-10 (0 being 'no hurt' and 10 being 'hurts worst').
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1 hour
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協力者と研究者
捜査官
捜査官
- 主任研究者:Elitsa Veneva, DMD、Medical University - Plovdiv, Bulgaria
出版物と役立つリンク
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 (実際)
一次修了
研究の完了 (実際)
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
その他の研究ID番号
その他の研究ID番号
- PlovdivMU
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