- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT03412721
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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Plovdiv, Болгария, 4000
- Department of Pediatric Dentistry, Faculty of Dental Medicine
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: 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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Плацебо Компаратор: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Pain felt during treatment according to a visual analogue scale
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Changes in pulpal sensibility to electrical stimuli by electrical pulp tester
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Elitsa Veneva, DMD, Medical University - Plovdiv, Bulgaria
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- PlovdivMU
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
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Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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