Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions (VCMX-SCTG)
Volume-Stable Xenogeneic Collagen Matrix Versus Subepithelial Connective Tissue Graft for the Treatment of Multiple Gingival Recessions: A 12-Month Randomized Controlled Clinical Trial
Gingival recession is a clinical condition in which the gingival margin is displaced apically, exposing the root surface. This condition may be associated with esthetic concerns, dentin hypersensitivity, and difficulties in oral hygiene. Subepithelial connective tissue grafting is considered a standard surgical approach for root coverage, but it requires harvesting tissue from the palate, which may increase postoperative discomfort. Volume-stable xenogeneic collagen matrices have been proposed as an alternative biomaterial to reduce the need for a palatal donor site.
This randomized controlled clinical trial will compare a volume-stable xenogeneic collagen matrix with an autogenous subepithelial connective tissue graft for the treatment of multiple gingival recessions. Participants will be allocated to one of two treatment groups. The test group will receive root coverage surgery using a volume-stable collagen matrix, while the control group will receive root coverage surgery using a subepithelial connective tissue graft. Clinical, patient-reported, esthetic, and digital outcomes will be assessed at baseline and during follow-up visits up to 12 months.
The primary outcome will be the change in gingival recession depth from baseline to 12 months. Secondary outcomes will include keratinized tissue width, gingival thickness, percentage of root coverage, complete root coverage, dentin hypersensitivity, patient-reported satisfaction, early wound healing, and digital volumetric changes assessed by intraoral scanning.
Обзор исследования
Статус
Условия
Подробное описание
This study is a randomized controlled clinical trial designed to evaluate the clinical performance of a volume-stable xenogeneic collagen matrix compared with an autogenous subepithelial connective tissue graft in the treatment of multiple gingival recessions.
Eligible participants presenting multiple gingival recessions will be recruited and allocated to one of two parallel treatment groups. In the test group, participants will receive root coverage surgery using a volume-stable xenogeneic collagen matrix associated with a coronally advanced flap. In the control group, participants will receive root coverage surgery using an autogenous subepithelial connective tissue graft associated with a coronally advanced flap.
Clinical assessments will include gingival recession depth, keratinized tissue width, probing depth, clinical attachment level, gingival thickness, percentage of root coverage, and complete root coverage. Patient-reported outcomes will include dentin hypersensitivity, postoperative comfort, esthetic satisfaction, and acceptance of the procedure. Standardized clinical photographs and intraoral scans will be obtained during follow-up. Digital analyses will be used to assess changes in soft tissue volume over time.
The primary endpoint will be the change in gingival recession depth from baseline to 12 months. Secondary endpoints will include clinical, esthetic, patient-reported, wound healing, and digital volumetric outcomes assessed at predefined follow-up visits.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Edgar Daniel Vargas Quiroga, DDS, MSc
- Номер телефона: +551633153000
- Электронная почта: edgar.vargasquiroga@usp.br
Учебное резервное копирование контактов
- Имя: Arthur Belem Novaes Jr, DDS, PhD
- Электронная почта: novaesjr@forp.usp.br
Места учебы
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São Paulo
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Ribeirão Preto, São Paulo, Бразилия, 14040-904
- School of Dentistry of Ribeirão Preto, University of Sao Paulo
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Контакт:
- Edgar Daniel Vargas Quiroga, DDS, MSc
- Номер телефона: +551633153000
- Электронная почта: edgar.vargasquiroga@usp.br
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Контакт:
- Arthur Belem Novaes Jr, DDS, PhD
- Электронная почта: novaesjr@forp.usp.br
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Главный следователь:
- Arthur Belem Novaes Jr, DDS, PhD
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Младший исследователь:
- Edgar Daniel Vargas Quiroga, DDS, MSc
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Adults aged 18 years or older.
- Presence of at least two Cairo RT1 gingival recessions in anterior teeth and/or premolars.
- Gingival recession depth greater than or equal to 2 mm.
- Presence of at least 2 mm of keratinized gingiva apical to the gingival recession.
- Indication for root coverage treatment due to esthetic concern and/or dentin hypersensitivity.
- Sites with non-carious cervical lesions may be included if they are previously restored and, after restoration, present residual gingival recession greater than or equal to 2 mm.
- Good plaque control, defined as full-mouth plaque score and full-mouth marginal gingival bleeding score below 20%.
Exclusion Criteria:
- Current smokers or individuals who stopped smoking less than 12 months before enrollment.
- Decompensated systemic diseases.
- Pregnancy or lactation.
- Active periodontal disease.
- Untreated root caries.
- Previous mucogingival surgery in the study area.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Volume-Stable Collagen Matrix
Participants in this group will receive root coverage surgery using a volume-stable xenogeneic collagen matrix associated with a coronally advanced flap.
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A volume-stable xenogeneic collagen matrix will be used as a soft-tissue substitute for root coverage surgery.
The matrix will be placed over the recession defects and covered by a coronally advanced flap.
Другие имена:
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Активный компаратор: Subepithelial Connective Tissue Graft
Participants in this group will receive root coverage surgery using an autogenous subepithelial connective tissue graft associated with a coronally advanced flap.
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An autogenous subepithelial connective tissue graft will be harvested from the palate and used for root coverage surgery.
The graft will be placed over the recession defects and covered by a coronally advanced flap.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Gingival Recession Depth
Временное ограничение: Baseline, 3 months, 6 months, and 12 months
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Gingival recession depth will be measured clinically in millimeters as the distance from the cementoenamel junction to the gingival margin.
The main comparison between groups will be performed at 12 months.
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Baseline, 3 months, 6 months, and 12 months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Gingival Recession Width
Временное ограничение: Baseline, 3 months, 6 months, and 12 months
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Gingival recession width will be measured horizontally in millimeters at the level of the cementoenamel junction.
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Baseline, 3 months, 6 months, and 12 months
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Keratinized Tissue Width
Временное ограничение: Baseline, 3 months, 6 months, and 12 months
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Keratinized tissue width will be measured in millimeters from the gingival margin to the mucogingival junction.
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Baseline, 3 months, 6 months, and 12 months
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Gingival Thickness
Временное ограничение: Baseline, 3 months, 6 months, and 12 months
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Gingival thickness will be measured in millimeters at the treated sites using a standardized clinical method.
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Baseline, 3 months, 6 months, and 12 months
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Probing Depth
Временное ограничение: Baseline, 3 months, 6 months, and 12 months
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Probing depth will be measured in millimeters from the gingival margin to the bottom of the sulcus or pocket at the treated sites.
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Baseline, 3 months, 6 months, and 12 months
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Clinical Attachment Level
Временное ограничение: Baseline, 3 months, 6 months, and 12 months
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Clinical attachment level will be calculated in millimeters as probing depth plus gingival recession depth.
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Baseline, 3 months, 6 months, and 12 months
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Percentage of Root Coverage
Временное ограничение: 3 months, 6 months, and 12 months
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Percentage of root coverage will be calculated based on the reduction in gingival recession depth from baseline to 12 months.
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3 months, 6 months, and 12 months
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Complete Root Coverage
Временное ограничение: 3 months, 6 months, and 12 months
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Complete root coverage will be defined as the absence of residual gingival recession at the treated site.
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3 months, 6 months, and 12 months
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Dentin Hypersensitivity
Временное ограничение: Baseline, 3 months, 6 months, and 12 months
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Will be assessed after standardized air stimulation using a 0 to 100 visual analog scale.
A score of 0 indicates no pain or sensitivity, and a score of 100 indicates the worst imaginable pain or sensitivity.
Higher scores indicate worse dentin hypersensitivity.
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Baseline, 3 months, 6 months, and 12 months
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Patient-Reported Esthetic Satisfaction
Временное ограничение: Baseline, 3 months, 6 months, and 12 months
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Patient-reported esthetic satisfaction will be assessed using a 0 to 100 visual analog scale.
A score of 0 indicates complete dissatisfaction, and a score of 100 indicates complete satisfaction.
Higher scores indicate better esthetic satisfaction.
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Baseline, 3 months, 6 months, and 12 months
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Digital Volumetric Changes
Временное ограничение: Baseline, 3 months, 6 months, and 12 months
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Soft tissue volumetric changes will be assessed using intraoral scans and digital superimposition of three-dimensional Standard Tessellation Language (STL) models.
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Baseline, 3 months, 6 months, and 12 months
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Early Wound Healing
Временное ограничение: 7 days, 14 days, and 30 days
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Early wound healing will be assessed clinically during the postoperative period based on flap margin adaptation, suture stability, edema, inflammation, erythema, fibrin accumulation, tissue necrosis, epithelialization, biomaterial or graft exposure, and overall wound healing pattern.
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7 days, 14 days, and 30 days
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Arthur Belem Novaes Jr, DDS, PhD, University of Sao Paulo
- Учебный стул: Edgar Daniel Vargas Quiroga, DDS, MSc, University of Sao Paulo
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
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
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- CAAE 98199226.9.0000.5419 (Другой идентификатор: Plataforma Brasil / Brazilian CEP-CONEP System)
Планирование данных отдельных участников (IPD)
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Описание плана IPD
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.
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