Super Putty C-PRF/ Hyaluronic Acid Combination vs C-PRF in Gingival Phenotype Modification in Subjects With Thin Gingival Phenotype
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: C-PRF and Hyaluronic Acid, C-PRF.
- Кому может быть актуально
- Состояния в реестре: Thin Gingival Phenotype. Базовые параметры: 20 лет — 40 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
- Ирак
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Gingival Phenotype Modification Using Super-putty C-PRF/Hyaluronic Acid Combination Versus C-PRF Alone in Subjects With Thin Gingival Phenotype: Randomized Clinical Trials
Обзор
Randomized split mouth clinical trials study focused on comparing the efficacy of C-PRF/ Hyaluronic acid combination versus C-PRF injection alone in subjects with thin gingival phenotype.
Подробное описание
Gingival phenotype is an important periodontal parameter focused on the gingival thickness and keratinized tissue width.
The gingival phenotype is either thin or thick. Thick gingival phenotype resist infections and periodontal disease more than the thin gingival phenotype.
Multiple surgical approaches to modify the ginigval phenotype from thin to thick has been done in clinical dentistry.
While surgical approach is invasive, recent periodontal trends tends to go with non-invasive ways to treat periodontal conditions. It involves PRF injections as an example.
In this study we're utilizing the PRF combination with Hyaluronic acid and inject this combination to increase the gingival thickness and keratinized tissue width.
Вмешательства
- Другое C-PRF and Hyaluronic Acid
A mixed preparation consisting of 0.5 mL of Concentrated Platelet-Rich Fibrin (C-PRF) and 0.5 mL of 1.6% cross-linked hyaluronic acid, 0.2% natural Hyaluronic Acid. The mixture is administered via direct subepithelial injection at the mucogingival junction of the target teeth using a 30-gauge needle. 3 injections sessions with 10 days intervals and baseline, 3 months and 6 months follow up visits. - Другое C-PRF
1 mL of Concentrated Platelet-Rich Fibrin (C-PRF) is administered via direct subepithelial injection at the mucogingival junction of the target teeth using a 30-gauge needle. 3 injections sessions with 10 days intervals and baseline, 3 months and 6 months follow up visits.
Первичные конечные точки
- Changes in Gingival Thickness & Keratinized Tissue Width at baseline and at 6 months after the injection of C-PRF/ Hyaluronic acid [Срок оценки: baseline - 6 months follow up]
Критерии участия
Критерии включения
- Systemically healthy male or female adults aged 20 to 40 years.
- Non-smoker.
- Presence of a clinically thin gingival phenotype (gingival thickness ≤ 1.0 mm) at the targeted surgical sites.
- Presence of bilateral homologous teeth (e.g., both maxillary canines, or both mandibular first premolars) exhibiting the same thin gingival phenotype to allow for paired test and control sites within the same oral cavity.
- Patients must demonstrate a high standard of oral hygiene, defined as a full-mouth plaque score and full-mouth bleeding score of ≤ 10% following initial cause-related therapy.
- Willingness to comply with the 6-month follow-up schedule and provide written informed consent before enrollment.
Критерии исключения
- Any systemic disease or condition known to compromise wound healing or alter immune response (e.g., uncontrolled diabetes mellitus, autoimmune disorders, bleeding dyscrasias).
- Current or recent use of medications known to induce gingival enlargement (e.g., phenytoin, cyclosporine, calcium channel blockers) or medications affecting blood coagulation and platelet function (e.g., anticoagulants) within last 10 days of the procedure.
- Active periodontitis, defined by probing depths > 3 mm or bleeding on probing at the designated experimental sites
- Any previous history of mucogingival surgery, soft tissue grafting, or local trauma at the selected test or control sites.
- Current tobacco smoking or vaping, due to its well-documented detrimental effects on local angiogenesis and soft tissue grafting outcomes.
- Pregnant or lactating females, due to hormonal fluctuations that can temporarily alter the gingival tissue response and capillary permeability.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Одна группа
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Ирак · 1 центр
- Al-mustansiriyah university — Baghdad
Идентификаторы
NCT: NCT07682259 · Sajjad A. Shakir