Zmiany tkanek twardych i miękkich wokół implantu po natychmiastowym wszczepieniu z osłoną zębodołu i natychmiastową odbudową w porównaniu z wczesnym wszczepieniem w strefie estetycznej
Ocena zmian twardych i miękkich tkanek okołowszczepowych pomiędzy natychmiastowym wszczepieniem z techniką tarczy zębodołowej i natychmiastową odbudową a wczesnym wszczepieniem typu II w strefie estetycznej – randomizowane kontrolowane badanie kliniczne
This randomized controlled clinical trial aims to compare peri-implant hard and soft tissue dimensional changes following immediate implant placement with the socket shield technique and immediate restoration versus early type II implant placement with contour graft in the esthetic zone. The primary outcome is the Pink Esthetic Score (PES), while secondary outcomes include mid-facial mucosal recession, radiographic vertical and horizontal buccal bone remodeling, and patient satisfaction after 12 months.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Immediate implant placement is widely used for replacing non-restorable teeth in the esthetic zone. However, post-extraction remodeling of the buccal bone plate can lead to soft tissue recession and compromised esthetic outcomes. The socket shield technique has been proposed as a partial extraction therapy designed to preserve the buccal root fragment and maintain the facial bone and gingival architecture.
This single-center, prospective randomized controlled clinical trial aims to evaluate the effectiveness of the socket shield technique with immediate implant placement and immediate restoration compared with early type II implant placement with contour augmentation.
Forty-two patients requiring extraction of a single non-restorable tooth in the esthetic zone will be randomly allocated into two groups:
Test group: Immediate implant placement with socket shield technique and immediate restoration.
Control group: Early implant placement following soft tissue healing with contour augmentation.
Clinical, radiographic, and patient-reported outcomes will be assessed over a 12-month follow-up period.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Ajman Emirate
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Ajman, Ajman Emirate, Zjednoczone Emiraty Arabskie, 4184
- Gulf Medical University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Adults aged 18 years or older
- Patients presenting with a single non-restorable tooth in the esthetic zone indicated for extraction and implant replacement
- Presence of a thin buccal bone plate (<1 mm)
- Adequate bone volume to allow implant placement in a prosthetically ideal position
- Intact socket walls following tooth extraction
- Ability to achieve primary implant stability ≥35 Ncm at the time of implant placement
- Patients willing to participate in the study and able to provide written informed consent
Exclusion Criteria:
- History of systemic diseases that may affect bone healing
- Use of medications that may influence bone metabolism (e.g., bisphosphonates)
- Smoking within the past 5 years
- Presence of acute infection at the surgical site or adjacent teeth
- Teeth with vertical or subcrestal horizontal root fractures on the buccal aspect
- Presence of internal or external root resorption
- Severe periodontal destruction at the implant site
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Immediate Implant Placement and Immediate Restoration with the Socket Shield Tech
Participants allocated to this experimental group will undergo immediate implant placement following partial extraction therapy using the socket shield technique. After decoronation and preparation of the buccal root fragment, the implant osteotomy will be created palatal to the retained root fragment to achieve correct prosthetic positioning. The gap between the implant and the root fragment will be filled with deproteinized bovine bone mineral, and an immediate provisional restoration will be placed using a PMMA temporary crown. Final implant-supported restoration will be delivered after approximately 3 months. Participants will be followed for 12 months to evaluate peri-implant hard and soft tissue changes and esthetic outcomes. |
mmediate implant placement following partial extraction therapy using the socket shield technique. After decoronation and preparation of the buccal root fragment, the implant osteotomy will be created palatal to the retained root fragment to achieve correct prosthetic positioning. The gap between the implant and the root fragment will be filled with deproteinized bovine bone mineral, and an immediate provisional restoration will be placed using a PMMA temporary crown. Final implant-supported restoration will be delivered after approximately 3 months
Inne nazwy:
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Aktywny komparator: Early Type II Implant placement with Contour augmentation with Xenograft
Participants assigned to this active comparator group will undergo atraumatic extraction of the non-restorable tooth followed by early type II implant placement after a healing period of approximately 4-8 weeks. During implant surgery, a full-thickness flap will be elevated and the implant will be placed in the ideal prosthetic position. Contour augmentation will be performed using autogenous bone chips and deproteinized bovine bone mineral particles, which will be covered with a collagen membrane. After approximately 3 months of healing, the implant will be restored with a definitive implant-supported prosthetic restoration. Participants will be followed for 12 months to assess peri-implant hard and soft tissue changes and esthetic outcomes. |
atraumatic extraction of the non-restorable tooth followed by early type II implant placement after a healing period of approximately 4-8 weeks. During implant surgery, a full-thickness flap will be elevated and the implant will be placed in the ideal prosthetic position. Contour augmentation will be performed using autogenous bone chips and deproteinized bovine bone mineral particles, which will be covered with a collagen membrane. After approximately 3 months of healing, the implant will be restored with a definitive implant-supported prosthetic restoration
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Pink Esthetic Score (PES)
Ramy czasowe: 12 months after implant restoration
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Evaluation of peri-implant soft tissue esthetic outcome using the Pink Esthetic Score, which assesses seven parameters including mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar process deficiency, soft tissue color, and texture around the implant restoration. Each parameter is scored from 0 to 2, with a maximum score of 14 indicating optimal esthetic outcome. |
12 months after implant restoration
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Peri-implant Mid-facial Mucosal Recession
Ramy czasowe: 12 months after implant placement
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Measurement of vertical changes in the mid-facial peri-implant mucosal level. Digital intraoral scans obtained at baseline and during follow-up will be superimposed using digital analysis software to quantify the vertical displacement of the facial mucosal zenith relative to the baseline position. |
12 months after implant placement
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Horizontal Radiographic Peri-implant Bone Changes
Ramy czasowe: 12 months after implant Restoration
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Assessment of horizontal dimensional changes of the buccal peri-implant bone using cone beam computed tomography (CBCT). The horizontal distance between the implant surface and the outer surface of the buccal bone plate will be measured at the mid-buccal aspect 1 mm apical to the buccal bone crest. Measurements obtained immediately after implant placement will be compared with those obtained at follow-up to determine peri-implant bone remodeling. |
12 months after implant Restoration
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Vertical Radiographic Peri-implant Bone Changes
Ramy czasowe: 12 months after implant Restoration
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Assessment of vertical dimensional changes of the buccal peri-implant bone using cone beam computed tomography (CBCT). The vertical distance between the implant platform and the buccal alveolar crest at the mid-buccal aspect of the implant will be measured. Measurements obtained immediately after implant placement will be compared with those obtained at follow-up to determine vertical peri-implant bone remodeling. |
12 months after implant Restoration
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Patient Satisfaction
Ramy czasowe: 12 months after implant restoration
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Patient-reported satisfaction with the implant treatment will be assessed using a Visual Analog Scale (VAS) questionnaire evaluating esthetics and functional outcomes of the implant-supported restoration. The VAS ranges from 0 to 10, where higher scores indicate greater patient satisfaction. |
12 months after implant restoration
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Współpracownicy i badacze
Sponsor
Śledczy
- Krzesło do nauki: Mohamed Atef Sayed, Ph.D., Assistant Professor of Periodontics
- Główny śledczy: Moheb Silwadi, M.D.S, Gulf Medical University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- IRB-COD-STD-87-Feb-2025
- IRB-COD-STD-87-Feb-2025 (Inny identyfikator: Gulf Medical University)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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