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Peri-Implant Soft Tissue Augmentation Using a Free Connective Tissue Graft With an Epithelial Collar

29 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

32

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Rosja
      • Moscow, Rosja
        • I.M. Sechenov First Moscow State Medical University (Sechenov University)

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Tak

Opis

  1. Written informed consent for participation in the study;
  2. Age between 18 and 45 years;
  3. Bounded edentulous defects of the upper or lower jaw involving 1-2 teeth combined with soft tissue thickness deficiency around dental implants (<2 mm);
  4. Teeth without periodontal pathology, with probing depth not exceeding 3 mm throughout the gingival sulcus;
  5. Satisfactory level of oral hygiene;
  6. Absence of systemic diseases in the stage of exacerbation or decompensation.

Non-inclusion criteria:

  1. Patients who previously underwent connective tissue graft harvesting from the same donor site;
  2. Patients with impacted third molars in the donor site area;
  3. Presence of concomitant diseases in the stage of exacerbation or decompensation;
  4. Patients with malignant neoplasms, as well as patients who underwent radiation therapy or chemotherapy within the previous 5 years;
  5. Patients with a smoking history of more than 10 years.

Exclusion Criteria:

  1. Patient refusal to continue participation in the study;
  2. Pregnant or breastfeeding women;
  3. Patients with coagulation disorders (hemophilia, von Willebrand disease, or anticoagulant therapy);
  4. Patients with diseases affecting soft tissue healing processes (insulin-dependent diabetes mellitus).

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: first group
Patients will receive a free connective tissue graft without an epithelial collar
Procedura: Free connective tissue graft without an epithelial collar
  1. Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation, preparation of the implant bed and placement of the dental implant according to the standard protocol.
  2. Formation of the recipient site in the vestibular area.
  3. Harvesting of free connective tissue graft from the maxilla tuberosity area or palate and its adaptation to the recipient site.
  4. Fixation of the graft to the vestibular mucosal-periosteal flap and tight suturing of the wound in the recipient area.
  5. Suturing of the wound in the donor site.
Eksperymentalny: second group
Patients will receive a free connective tissue graft with epithelial collar
Procedura: Free connective tissue graft with epithelial collar
  1. Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation, preparation of the implant bed and placement of the dental implant according to the standard protocol.
  2. Formation of the recipient site in the vestibular area.
  3. Harvesting of free connective tissue graft with epithelial strip from the maxilla tuberosity area or palate and its adaptation to the recipient site.
  4. Fixation of the graft to the vestibular mucosal-periosteal flap and tight suturing of the wound in the recipient area.
  5. Suturing of the wound in the donor site.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in the Width of Keratinized Mucosa
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in the Width of Keratinized Mucosa
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

I.M. Sechenov First Moscow State Medical University

Śledczy

  • Główny śledczy: Igor P Ashurko, I.M. Sechenov First Moscow State Medical University (Sechenov University)

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

20 czerwca 2024

Zakończenie podstawowe (Szacowany)

20 czerwca 2026

Ukończenie studiów (Szacowany)

20 sierpnia 2026

Daty rejestracji na studia

Pierwszy przesłany

29 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

29 maja 2026

Pierwszy wysłany (Rzeczywisty)

4 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • AI-05

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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