Peri-Implant Soft Tissue Augmentation Using a Free Connective Tissue Graft With an Epithelial Collar
29 мая 2026 г. обновлено: I.M. Sechenov First Moscow State Medical University
Application of a Free Connective Tissue Graft With an Epithelial Collar for Peri-Implant Soft Tissue Augmentation in Patients With Soft Tissue Deficiency Around Dental Implants
A prospective randomized interventional clinical trial (RCT) with a parallel-group design is planned.
The study sample will include 32 patients randomly allocated into two groups according to the surgical intervention performed.
In the first group, a free connective tissue graft with an epithelial collar will be used.
In the second group, a free connective tissue graft without an epithelial collar will be used.
In the postoperative period, assessment of changes in the width of keratinized mucosa, soft tissue thickness, pain severity, postoperative swelling, and patient quality of life will be performed.
Обзор исследования
Статус
Активный, не рекрутирующий
Условия
Подробное описание
The aim of this study is to perform a comparative analysis of the effectiveness of free connective tissue grafts with and without an epithelial collar for peri-implant soft tissue augmentation. Examination and treatment of patients will be carried out at the Department of Oral Surgery of the E.V. Borovsky Institute of Dentistry, Sechenov University.
The study population will include patients with bounded or distal edentulous defects of the upper or lower jaw combined with soft tissue thickness deficiency around dental implants (<2 mm), requiring peri-implant soft tissue augmentation using a free connective tissue graft.
All patients will be randomly allocated into two groups according to the surgical intervention method. In the first group (n=16), a free connective tissue graft without an epithelial collar will be used, while in the second group (n=16), a free connective tissue graft with an epithelial collar will be used. The groups will be comparable in terms of age and sex characteristics.
Patient randomization will be performed intraoperatively as follows: after dental implant placement and preparation of the recipient site, an envelope containing the randomly assigned treatment method will be opened. Patients in both groups will undergo dental implant placement according to the standard surgical protocol combined with peri-implant soft tissue augmentation.
A mucosal incision will be performed followed by elevation of a mucoperiosteal flap, preparation of the implant bed, and placement of the dental implant. Subsequently, the recipient site will be prepared and a free connective tissue graft harvested from the maxillary tuberosity or palatal area. Depending on the allocated group, a graft with or without an epithelial collar will be used. The graft will be fixed to the mucoperiosteal flap, followed by tension-free wound closure, while the donor site will be closed primarily.
In the postoperative period, standard antibacterial and anti-inflammatory therapy combined with topical antiseptic agents will be prescribed.
Тип исследования
Интервенционный
Регистрация (Действительный)
32
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
-
-
-
Moscow, Россия
- I.M. Sechenov First Moscow State Medical University (Sechenov University)
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Да
Описание
- Written informed consent for participation in the study;
- Age between 18 and 45 years;
- Bounded edentulous defects of the upper or lower jaw involving 1-2 teeth combined with soft tissue thickness deficiency around dental implants (<2 mm);
- Teeth without periodontal pathology, with probing depth not exceeding 3 mm throughout the gingival sulcus;
- Satisfactory level of oral hygiene;
- Absence of systemic diseases in the stage of exacerbation or decompensation.
Non-inclusion criteria:
- Patients who previously underwent connective tissue graft harvesting from the same donor site;
- Patients with impacted third molars in the donor site area;
- Presence of concomitant diseases in the stage of exacerbation or decompensation;
- Patients with malignant neoplasms, as well as patients who underwent radiation therapy or chemotherapy within the previous 5 years;
- Patients with a smoking history of more than 10 years.
Exclusion Criteria:
- Patient refusal to continue participation in the study;
- Pregnant or breastfeeding women;
- Patients with coagulation disorders (hemophilia, von Willebrand disease, or anticoagulant therapy);
- Patients with diseases affecting soft tissue healing processes (insulin-dependent diabetes mellitus).
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
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 |
|---|---|
|
Активный компаратор: first group
Patients will receive a free connective tissue graft without an epithelial collar
|
|
|
Экспериментальный: second group
Patients will receive a free connective tissue graft with epithelial collar
|
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in the Width of Keratinized Mucosa
Временное ограничение: Day 90 compared to the 0th day (initial value)
|
Measurements will be performed using optical impressions obtained with the Primescan intraoral scanner (Dentsply/Sirona) or conventional impressions followed by digital scanning before surgery and on postoperative day 90.
Subsequently, STL files will be superimposed using GOM Inspect software, and contour changes will be assessed at three equidistant points.
|
Day 90 compared to the 0th day (initial value)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in the Width of Keratinized Mucosa
Временное ограничение: Day 180 compared to the 0th day (initial value)
|
Measurements will be performed using optical impressions obtained with the Primescan intraoral scanner (Dentsply/Sirona) or conventional impressions followed by laboratory scanning before surgery and on postoperative day 180.
Subsequently, STL files will be superimposed using GOM Inspect software, and contour changes will be assessed at three equidistant points.
|
Day 180 compared to the 0th day (initial value)
|
|
Assessment of Scar Formation According to the Modified Scar Index (MSI)
Временное ограничение: Day 90 compared to the 0th day (initial value)
|
Assessment of postoperative soft tissue scar quality around dental implants is performed using the Modified Scar Index (MSI) according to Mombelli et al., based on the evaluation of five parameters: scar color, scar contour, soft tissue deformity, scar tissue texture, and wound margin separation.
Each parameter is assessed using a 3-point scale, where: 0 = optimal tissue condition; 1 = moderate scar changes; 2 = pronounced scar changes.
The total MSI score ranges from 0 to 10, with lower scores indicating better clinical outcomes and minimal scar formation.
Clinical assessment is performed visually and by palpation, with additional evaluation using clinical photographs when necessary.
|
Day 90 compared to the 0th day (initial value)
|
|
Assessment of Scar Formation According to the Modified Scar Index (MSI)
Временное ограничение: Day 180 compared to the 0th day (initial value)
|
Assessment of postoperative soft tissue scar quality around dental implants is performed using the Modified Scar Index (MSI) according to Mombelli et al., based on the evaluation of five parameters: scar color, scar contour, soft tissue deformity, scar tissue texture, and wound margin separation.
Each parameter is assessed using a 3-point scale, where: 0 = optimal tissue condition; 1 = moderate scar changes; 2 = pronounced scar changes.
The total MSI score ranges from 0 to 10, with lower scores indicating better clinical outcomes and minimal scar formation.
Clinical assessment is performed visually and by palpation, with additional evaluation using clinical photographs when necessary.
|
Day 180 compared to the 0th day (initial value)
|
|
Assessment of Pain Severity
Временное ограничение: 4 hours compared to the 0th day (initial value)
|
Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain.
|
4 hours compared to the 0th day (initial value)
|
|
Assessment of Pain Severity
Временное ограничение: Day 1 compared to the 0th day (initial value)
|
Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain.
|
Day 1 compared to the 0th day (initial value)
|
|
Assessment of Pain Severity
Временное ограничение: Day 3 compared to the 0th day (initial value)
|
Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain.
|
Day 3 compared to the 0th day (initial value)
|
|
Assessment of Pain Severity
Временное ограничение: Day 5 compared to the 0th day (initial value)
|
Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain.
|
Day 5 compared to the 0th day (initial value)
|
|
Assessment of Pain Severity
Временное ограничение: Day 7 compared to the 0th day (initial value)
|
Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain.
|
Day 7 compared to the 0th day (initial value)
|
|
Assessment of Postoperative Swelling Severity
Временное ограничение: Day 1 compared to the 0th day (initial value)
|
Assessment of collateral soft tissue swelling compared with adjacent tissues is performed using the following scale: 0 = no swelling; 1 = moderate swelling; 2 = severe swelling.
|
Day 1 compared to the 0th day (initial value)
|
|
Assessment of Postoperative Swelling Severity
Временное ограничение: Day 3 compared to the 0th day (initial value)
|
Assessment of collateral soft tissue swelling compared with adjacent tissues is performed using the following scale: 0 = no swelling; 1 = moderate swelling; 2 = severe swelling.
|
Day 3 compared to the 0th day (initial value)
|
|
Assessment of Postoperative Swelling Severity
Временное ограничение: Day 5 compared to the 0th day (initial value)
|
Assessment of collateral soft tissue swelling compared with adjacent tissues is performed using the following scale: 0 = no swelling; 1 = moderate swelling; 2 = severe swelling.
|
Day 5 compared to the 0th day (initial value)
|
|
Assessment of Postoperative Swelling Severity
Временное ограничение: Day 7 compared to the 0th day (initial value)
|
Assessment of collateral soft tissue swelling compared with adjacent tissues is performed using the following scale: 0 = no swelling; 1 = moderate swelling; 2 = severe swelling.
|
Day 7 compared to the 0th day (initial value)
|
|
Assessment of Bleeding
Временное ограничение: Day 1 compared to the 0th day (initial value)
|
Assessment of the presence of a blood taste in the mouth is performed using the following scale: 0 = no blood taste; 1 = intermittent blood taste; 2 = constant blood taste.
|
Day 1 compared to the 0th day (initial value)
|
|
Assessment of Bleeding
Временное ограничение: Day 3 compared to the 0th day (initial value)
|
Assessment of the presence of a blood taste in the mouth is performed using the following scale: 0 = no blood taste; 1 = intermittent blood taste; 2 = constant blood taste.
|
Day 3 compared to the 0th day (initial value)
|
|
Assessment of Bleeding
Временное ограничение: Day 5 compared to the 0th day (initial value)
|
Assessment of the presence of a blood taste in the mouth is performed using the following scale: 0 = no blood taste; 1 = intermittent blood taste; 2 = constant blood taste.
|
Day 5 compared to the 0th day (initial value)
|
|
Assessment of Bleeding
Временное ограничение: Day 7 compared to the 0th day (initial value)
|
Assessment of the presence of a blood taste in the mouth is performed using the following scale: 0 = no blood taste; 1 = intermittent blood taste; 2 = constant blood taste.
|
Day 7 compared to the 0th day (initial value)
|
|
Assessment of Analgesic Intake
Временное ограничение: Day 1 compared to the 0th day (initial value)
|
Assessment of the number of Nimesulide 100 mg tablets taken per day.
|
Day 1 compared to the 0th day (initial value)
|
|
Assessment of Analgesic Intake
Временное ограничение: Day 3 compared to the 0th day (initial value)
|
Assessment of the number of Nimesulide 100 mg tablets taken per day.
|
Day 3 compared to the 0th day (initial value)
|
|
Assessment of Analgesic Intake
Временное ограничение: Day 5 compared to the 0th day (initial value)
|
Assessment of the number of Nimesulide 100 mg tablets taken per day.
|
Day 5 compared to the 0th day (initial value)
|
|
Assessment of Analgesic Intake
Временное ограничение: Day 7 compared to the 0th day (initial value)
|
Assessment of the number of Nimesulide 100 mg tablets taken per day.
|
Day 7 compared to the 0th day (initial value)
|
|
Quality of Life Assessment According to OHIP-14
Временное ограничение: Day 0 (initial value)
|
Assessment of patient quality of life is performed using a questionnaire consisting of 10 questions.
The severity of each parameter should be rated from 0 to 4 points, where "0" = absence of the symptom and "4" = symptom is strongly pronounced.
|
Day 0 (initial value)
|
|
Quality of Life Assessment According to OHIP-14
Временное ограничение: Day 7 compared to the 0th day (initial value)
|
Assessment of patient quality of life is performed using a questionnaire consisting of 10 questions.
The severity of each parameter should be rated from 0 to 4 points, where "0" = absence of the symptom and "4" = symptom is strongly pronounced.
|
Day 7 compared to the 0th day (initial value)
|
|
Quality of Life Assessment According to OHIP-14
Временное ограничение: Day 90-93 compared to the 0th day (initial value)
|
Assessment of patient quality of life is performed using a questionnaire consisting of 10 questions.
The severity of each parameter should be rated from 0 to 4 points, where "0" = absence of the symptom and "4" = symptom is strongly pronounced.
|
Day 90-93 compared to the 0th day (initial value)
|
|
Quality of Life Assessment According to OHIP-14
Временное ограничение: Day 180-186 compared to the 0th day (initial value)
|
Assessment of patient quality of life is performed using a questionnaire consisting of 10 questions.
The severity of each parameter should be rated from 0 to 4 points, where "0" = absence of the symptom and "4" = symptom is strongly pronounced.
|
Day 180-186 compared to the 0th day (initial value)
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Igor P Ashurko, I.M. Sechenov First Moscow State Medical University (Sechenov University)
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
20 июня 2024 г.
Первичное завершение (Оцененный)
20 июня 2026 г.
Завершение исследования (Оцененный)
20 августа 2026 г.
Даты регистрации исследования
Первый отправленный
29 мая 2026 г.
Впервые представлено, что соответствует критериям контроля качества
29 мая 2026 г.
Первый опубликованный (Действительный)
4 июня 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
4 июня 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
29 мая 2026 г.
Последняя проверка
1 мая 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- AI-05
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
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. .