Oral Mucosa Wound Healing After Gingival Recession Treatment in Diabetic Patients. A Clinical Study.
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Coronally Advance Flap associated with connective tissue graft (CAF+CTG).
- Кому может быть актуально
- Состояния в реестре: Diabetes Mellitus, Gingival Recession, Generalized, Gingival Recession, Localized. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Oral Mucosa Wound Healing in Diabetic Patients. A Clinical Study on Closed Wounds
Обзор
The goal of this clinical trial is to evaluate local and systemic factors involved in oral mucosal healing after gingival recession treatment in diabetic patients and to compare them with those in non-diabetic patients. Diabetic and non-diabetic volunteers of both sexes aged ≥ 18 years with gingival recession may participate. The main questions it aims to answer are: 1. If the gingival recession reduction and percentage of root coverage are different in diabetics compared to non-diabetics. 2. If different factors, such as the oral microbiome, inflammatory markers, and others, are associated with the clinical outcome. Participants will be asked: * Receive the procedure to treat their gingival recession defects * To attend follow-up visits at 7, 14, 30, 90, and 180 days after treatment. * To provide different biological samples * To answer different questionnaires.
Вмешательства
- Процедура Coronally Advance Flap associated with connective tissue graft (CAF+CTG)
A CAF will be performed following the gingival recession (GR) defect features extending beyond the mucogingival junction (MGJ) in a split-full-split thickness design. In sequence, a 2-mm thick free gingival graft (FGG), measuring 15 × 5 mm, will be harvested from the palatal area between the distal of the canine and the mesial aspect of the first molar. The FGG will be trimmed based on the GR defect features and de-epithelialized to achieve a final thickness of 1 mm. The de-epithelialized graft
Первичные конечные точки
- gingival recession reduction [Срок оценки: 6 months]
Вторичные конечные точки (9)
- Probing depth [Срок оценки: 6 month]
- Clinical attachment level [Срок оценки: 6 months]
- PROMIS Adult Sleep Disturbance Survey [Срок оценки: Baseline and up to 4 weeks]
- Insomnia Severity Index Survey [Срок оценки: Baseline and up to 4 weeks]
- Change in Dentin hypersensitivity [Срок оценки: Baseline and up to 6 months]
- Number of analgesics [Срок оценки: 7 days]
- Discomfort [Срок оценки: 7 days]
- Root Coverage Esthetic Score [Срок оценки: 6 months]
- gingival crevicular fluid (GCF) inflammatory markers [Срок оценки: 6 months]
Критерии участия
Критерии включения
- aged ≥ 18 years;
- non-diabetic and diabetic patients (HbA1c>7% (American Diabetes Association 2025) managed with oral hypoglycemic agents or insulin;
- in the need of gingival recession treatment (RT1) in upper or lower arches with identifiable or restored cement-enamel junction (CEJ);
- periodontal stable (BoP ≤25%)(Lang et al. 2003);
- no morphological or pathological conditions in the palatal mucosa.
Критерии исключения
- patients with cardiovascular, blood dyscrasias, and immunodeficiency that contraindicate surgical procedures;
- taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure;
- Pregnancy/lactation (assessed via self-report);
- current opportunistic oral lesions that mainly colonize the palate region;
- subjects that have taken antibiotics within the last 3 months or need for antibiotic prophylaxis;
- prisoners;
- signs or symptoms of active extra-oral head and neck infection (swelling) as determined by a dentist at the time of evaluation;
- subjects who cannot read or speak English or Spanish, and do not agree to having the assistance of an interpreter
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- College of Dentistry - University of Kentucky — Lexington
Публикации
- Meyer MD, Coelho RMI, Rangel-Coelho JP, Costa BC, Teixeira LN, Martinez EF, Casarin RCV, Santamaria MP, Franca FMG, Nociti-Jr FH, Lisboa-Filho PN, Kantovitz KR. Titanium dioxide nanotubes incorporated into conventional glass ionomer cement alter the biological behavior of pre-odontoblastic cells. Colloids Surf B Biointerfaces. 2025 Feb;246:114389. doi: 10.1016/j.colsurfb.2024.114389. Epub 2024 Nov PMID 39591848
- Santamaria MP, Mathias-Santamaria IF, Tavelli L, Barootchi S, Prato GPP. An updated evidence-based recommendation for the treatment of gingival recession associated with non-carious cervical lesions. J Periodontol. 2026 May;97(5):1010-1025. doi: 10.1002/jper.70049. Epub 2026 Jan 7. PMID 41498281
Идентификаторы
NCT: NCT07470281 · 109004