- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07822269
Dental Loupe Versus Dental Operating Microscope for Non-Surgical Periodontal Treatment
Comparison of the Effectiveness of Dental Loupe and Dental Operating Microscope in Non-Surgical Periodontal Treatment
Обзор исследования
Статус
Условия
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Tuğçe Paksoy, Associate Professor
- Номер телефона: +905534490452
- Электронная почта: tugceakap86@hotmail.com
Места учебы
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Ankara, Турция (Туркие)
- Еще не набирают
- Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi
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Контакт:
- Seval Ceylan Şen, Assistant Professor
- Номер телефона: +905333161232
- Электронная почта: dt.sceylan@hotmail.com
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Контакт:
- Özlem Saraç Atagün, Assistant Professor
- Номер телефона: +905055096482
- Электронная почта: ozlemsarac2806@hotmail.com
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Младший исследователь:
- Gülbahar Ustaoğlu, Associate Professor
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Kırklareli, Турция (Туркие)
- Еще не набирают
- Kırklareli Üniversitesi Tıp Fakültesi Tıbbi Mikrobiyoloji Anabilim Dalı
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Контакт:
- Mehmet Demirci, Professor
- Номер телефона: 05337106295
- Электронная почта: demircimehmet@hotmail.com
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Üsküdar
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Istanbul, Üsküdar, Турция (Туркие)
- Рекрутинг
- Sağlık Bilimleri Üniversitesi Hamidiye Diş Hekimliği Fakültesi
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Контакт:
- Tuğçe Paksoy, Associate Professor
- Номер телефона: +905534490452
- Электронная почта: tugceakap86@hotmai.com
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Контакт:
- Alima Budakçı, PHd candidate
- Номер телефона: +905319841597
- Электронная почта: alima-97@hotmail.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Being over 18 years of age
- Being systemically healthy
- Having at least 20 permanent teeth in both upper and lower jaws
- Having periodontitis
- Having the mental capacity to understand the research objectives and methods to be applied as explained in writing and orally
- Being convinced that the volunteer will be suitable and cooperative with the physician-patient before, during and after the procedure
- Not having any physical or psychological condition that would prevent mechanical debridement
- Not being a bacterial or viral carrier
Exclusion Criteria:
- Patients under 18 years of age
- Patients who are periodontally healthy
- Smoking more than 10 cigarettes a day
- Having received periodontal treatment within the last year
- Having used antibiotics within the last 3 months
- Being pregnant or breastfeeding
- Those with diabetes, chronic kidney failure, cancer, bleeding disorders, connective tissue diseases, and similar chronic diseases
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Dental Loupe
A split-mouth study design was planned for the same patient.
The patient's right or left upper or lower jaw would be treated with a dental loupe which determined by a coin toss.
Patients diagnosed with periodontitis (Stage 3-Grade A) in the periodontology clinic and undergoing routine non-surgical periodontal treatment would be included in the study if they voluntarily agreed to participate.
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After clinical measurements are taken from Stage 3 Grade A periodontitis patients presenting to the periodontology clinic, a coin toss determines which area will undergo mechanical debridement under dental loupe magnification and which area under dental microscope magnification.
Before starting the procedure, a plaque sample will be collected from the deepest pathological pockets in the relevant area for later microbiological examination.
Following supragingival and subgingival debridement under local anesthesia using Gracey curettes and an ultrasonic scaler, patients will be placed in a follow-up period.
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Экспериментальный: Dental Microscope
A split-mouth study design was planned for the same patient.
The patient's right or left upper or lower jaw would be treated with a dental microscope which determined by a coin toss.
Patients diagnosed with periodontitis (Stage 3-Grade A) in the periodontology clinic and undergoing routine non-surgical periodontal treatment would be included in the study if they voluntarily agreed to participate.
|
After clinical measurements are taken from Stage 3 Grade A periodontitis patients presenting to the periodontology clinic, a coin toss determines which area will undergo mechanical debridement under dental loupe magnification and which area under dental microscope magnification.
Before starting the procedure, a plaque sample will be collected from the deepest pathological pockets in the relevant area for later microbiological examination.
Following supragingival and subgingival debridement under local anesthesia using Gracey curettes and an ultrasonic scaler, patients will be placed in a follow-up period.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Total microbial load
Временное ограничение: At enrollment. and 1 month control visit
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To determine the amount of microorganisms, plaque samples taken from each patient will be stored in Eppendorf tubes at -80°C with sterile distilled water until microbial analysis is performed. Plaque samples stored at -80°C in Eppendorf tubes will be transported to the laboratories where microbiological examination will be performed using personal vehicles in dry ice thermal storage bags. DNA isolation from all suture samples will be performed using the High Pure PCR Template according to the manufacturer's instructions. The DNA will be stored at 80°C until the process is complete. The 16S rRNA gene will be detected by qPCR and the total bacterial count will be determined. Real-time PCR procedures will be performed on a LightCycler 480 II system using the Fast Start Essential DNA Green Master Mix Kit according to the manufacturer's instructions. |
At enrollment. and 1 month control visit
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Probing Pocket Depth
Временное ограничение: At enrollment, 1 and 3 months control visits
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Probing pocket depth, or probing depth, is a numerical value obtained by measuring the distance between the gingival margin and the gingival sulcus/pocket floor using a standard periodontal probe with a tip approximately 0.4-0.5 mm in diameter, and rounding the measurement to the nearest millimeter.
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At enrollment, 1 and 3 months control visits
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Gingival Index
Временное ограничение: At enrollment, 1 and 3 months control visits
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This index was developed by Löe and Silness in 1963 and modified by various researchers in 1967. The system evaluates bleeding, the most fundamental sign of inflammation. The mesial, distal, vestibular, and lingual gingiva of the teeth are assessed. These values are then summed and divided by four to calculate the gingival index. Dividing the sum of these values by the number of teeth yields the individual score. 0 Healthy gingiva, no inflammation.
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At enrollment, 1 and 3 months control visits
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Papillary Bleeding Index
Временное ограничение: At enrollment, 1 and 3 months control visits
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Probing is used to evaluate bleeding in the gingival papillae. Probing is performed on all four half-jaws. However, to ensure the evaluation reflects inflammation of all papillae and to facilitate the procedure, evaluation is performed on the papillae on the oral surfaces of the upper right and lower left jaws, and on the facial surfaces of the teeth in the upper left and lower right jaws. The values obtained are then divided by the total number of papillae to find the average papillary bleeding index value. This index is quite important for patient motivation. Patients who see bleeding in their gums can easily identify the diseased area in their mouth and develop positive behaviors in applying the oral care procedures they have been taught. Papillary Bleeding Index Values 0 No bleeding.
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At enrollment, 1 and 3 months control visits
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Plaque Index (PI/ Turesky Gilmore Glickman modification of the Quingley Hein plaque index)
Временное ограничение: At enrollment, 1 and 3 months control visits
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The amount of plaque on facial and lingual surfaces is investigated using a plaque-staining agent. The total score is divided by the number of surfaces examined, and an index score is determined for the individual. The plaque-staining agent (Tri Plaque ID Gel™, GC Dental, USA) is applied to all tooth surfaces using a fine-tipped brush. Areas stained pink, purple, or blue on the tooth surfaces are scored from 0 to 5 (Score 0: no plaque, 1: independent plaque islands at the gingival margins, 2: thin bands of plaque at the gingival margins, 3: plaque covering no more than 1/3 of the tooth surface, 4: plaque covering no more than 2/3 of the tooth surface, 5: plaque covering more than 2/3 of the tooth surface). The entire mouth is divided into 6 different areas, and the average TQHPI values of the participants are calculated by taking the mathematical ratio of the values obtained from the mesial, distal, lingual, and vestibular surfaces of the specific teeth in each sextant. |
At enrollment, 1 and 3 months control visits
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Gingival Bleeding Index (Ainamo & Bay)
Временное ограничение: At enrollment, 1 and 3 month control visits
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This index assesses bleeding by gently probing within the gingival pocket.
The presence or absence of bleeding in the gingiva is evaluated based on the probing results.
A positive result is given if bleeding occurs within 10-15 seconds after probing the mesial, distal, vestibular, and lingual gingival areas of all teeth.
The ratio of the bleeding area to the examined area is expressed as a percentage.
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At enrollment, 1 and 3 month control visits
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Clinical attachment loss
Временное ограничение: At enrollment, 1 and 3 months control visits
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This value is obtained by measuring the distance between the pocket base and the enamel-cementum junction using a standard periodontal probe with a diameter of 0.4-0.5 mm and rounding the measurement to the nearest millimeter value.
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At enrollment, 1 and 3 months control visits
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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
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
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 25-25
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .