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Ovate Pontic Versus Essix Provisional After Tooth Extraction and Alveolar Ridge Preservation (Pontic-Essix) (Pontic-Essix)

31 lipca 2026 zaktualizowane przez: University of Bern

Socket Sealing With a Fixed Ovate Pontic Provisional Versus a Removable Provisional Following Tooth Extraction and Alveolar Ridge Preservation: A Randomized Controlled Trial

This randomized controlled trial compares two provisional socket-sealing concepts following single non-molar tooth extraction and alveolar ridge preservation: a fixed, tooth-supported, 3D-printed ovate pontic provisional restoration providing active soft tissue support (test) versus a removable Essix-type provisional restoration without intentional soft tissue contact combined with a porcine collagen matrix seal (control). Both groups receive alveolar ridge preservation using a deproteinized bovine bone mineral with 10% collagen. The primary endpoint is interproximal soft tissue height at 5 months, adjusted for baseline, assessed by digital superimposition of intraoral surface scans. Up to 40 participants will be enrolled at the University of Bern School of Dental Medicine.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

Following tooth extraction, dimensional changes of the alveolar ridge and loss of interproximal soft tissue height may compromise esthetic and prosthetic outcomes. Alveolar ridge preservation attenuates hard tissue resorption but provides limited active support for the overlying soft tissues during healing. An ovate pontic provisional restoration may provide active soft tissue support and thereby help preserve interproximal soft tissue height. To date, no randomized controlled trial has compared a fixed ovate pontic provisional restoration with a removable non-contact Essix provisional restoration in the context of alveolar ridge preservation.

This is a single-center, open-label, confirmatory, randomized controlled trial with two parallel groups and 1:1 allocation. An adaptive design with an internal pilot phase (n=20) and blinded sample size re-estimation based on the residual variance of the primary endpoint is applied, up to a predefined maximum of 40 participants.

All participants undergo minimally traumatic, flapless single non-molar tooth extraction and alveolar ridge preservation with Bio-Oss Collagen. Test group: socket sealing by a fixed, 3D-printed ovate pontic provisional restoration providing active soft tissue support. Control group: socket sealing with Mucograft Seal plus a removable Essix-type provisional restoration positioned without intentional soft tissue contact.

Follow-up visits are performed at 2 weeks, 4 weeks, and 5 months. At baseline (T0) and at 5 months, intraoral surface scans, clinical photographs, cone-beam computed tomography, and patient-reported outcomes are collected. The between-group treatment effect on the primary endpoint is estimated using ANCOVA with the 5-month value as dependent variable, treatment group as fixed factor, and the baseline value as covariate; jaw is included as an additional between-subject factor.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

40

Faza

  • Nie dotyczy

Kontakty i lokalizacje

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

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

    • Canton of Bern
      • Bern, Canton of Bern, Szwajcaria, 3010
        • University of Bern, Department of Reconstructive Dentistry and Gerodontology
        • Kontakt:

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
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  • Adults aged 18 years or older
  • ASA physical status I or II
  • Requiring a single non-molar tooth extraction (incisor, canine, or premolar) in the maxilla or mandible, with planned tooth replacement
  • Extraction site bounded by natural, periodontally stable adjacent teeth
  • Intact alveolar socket upon extraction, or no more than one bony wall (facial, palatal, or lingual) presenting a dehiscence extending less than 50% of the total bony wall height
  • Willingness and ability to comply with the follow-up protocol
  • Ability to give informed consent, as documented by signature

Exclusion Criteria:

  • Current smokers, or former smokers who quit less than 6 months before extraction
  • Uncontrolled diabetes mellitus (HbA1c > 7.0%)
  • Clinical attachment loss ≥ 2 mm at the extraction site
  • Active or recent chemotherapy, or history of head and neck radiotherapy
  • Current or previous bisphosphonate therapy within the past 10 years
  • Immunosuppressive medication
  • Active oral or systemic acute infection
  • Severe hematologic disorder, hepatic or renal failure, or any clinically relevant bleeding disorder or anticoagulant medication that cannot be safely managed for the planned surgical procedure
  • Pregnancy or lactation
  • Known allergy or hypersensitivity to any of the study materials, including bovine-derived bone substitute, porcine-derived collagen matrix, or collagen-containing biomaterials
  • Any other disease or medication that may compromise normal wound healing
  • Inability to follow the study procedures (e.g., insufficient language comprehension, cognitive impairment, psychological disorder, or dementia)
  • Known or suspected non-compliance
  • Participation in another clinical trial that may interfere with the present study

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: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Fixed ovate pontic provisional
Following minimally traumatic, flapless tooth extraction, the alveolar socket is grafted with Bio-Oss Collagen. Socket sealing is achieved by a fixed, 3D-printed provisional restoration incorporating an ovate pontic design that extends approximately 2 mm apical to the mucosal margin, providing active soft tissue support to maintain interproximal papilla height and facial soft tissue contour during healing. The provisional is retained by adhesive bonding or temporary cementation on the adjacent teeth. No additional collagen matrix or sutures are placed.
Deproteinized bovine bone mineral with 10% collagen (Geistlich Pharma AG, Wolhusen, Switzerland). Used for alveolar ridge preservation by socket grafting after tooth extraction. CE-marked and used within the approved indication.
Inne nazwy:
  • Fixed ovate pontic provisional
  • Removable Essix provisional with collagen matrix seal
Patient-specific 3D-printed provisional restoration (PMMA or comparable clinically approved dental provisional material) incorporating an ovate pontic design. Retained by adhesive bonding or temporary cementation on the adjacent teeth. The convex, highly polished pontic extends approximately 2 mm apical to the mucosal margin and above the level of the bone graft, providing active soft tissue support.
Aktywny komparator: Removable Essix provisional with collagen matrix seal
Following minimally traumatic, flapless tooth extraction, the alveolar socket is grafted with Bio-Oss Collagen. The socket is sealed with a porcine-derived collagen matrix (Mucograft Seal) secured with four to six single interrupted sutures, without primary closure. A removable Essix-type provisional restoration with an integrated artificial tooth is delivered; the pontic is positioned above the mucosal level without intentional soft tissue contact.
Deproteinized bovine bone mineral with 10% collagen (Geistlich Pharma AG, Wolhusen, Switzerland). Used for alveolar ridge preservation by socket grafting after tooth extraction. CE-marked and used within the approved indication.
Inne nazwy:
  • Fixed ovate pontic provisional
  • Removable Essix provisional with collagen matrix seal
Patient-specific 3D-printed provisional restoration (PMMA or comparable clinically approved dental provisional material) incorporating an ovate pontic design. Retained by adhesive bonding or temporary cementation on the adjacent teeth. The convex, highly polished pontic extends approximately 2 mm apical to the mucosal margin and above the level of the bone graft, providing active soft tissue support.
Patient-specific removable thermoplastic Essix-type appliance with an integrated artificial tooth. The pontic is positioned above the mucosal level without intentional soft tissue contact. Delivered at the surgical visit after socket sealing with the collagen matrix.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Interproximal soft tissue height at 5 months
Ramy czasowe: Baseline (T0) and 5 months after tooth extraction
Interproximal soft tissue height at 5 months, calculated per participant as the mean of the mesial and distal measurements and expressed in millimeters. Measurements are obtained by digital superimposition of baseline and 5-month intraoral surface scans (Geomagic Control X, 3D Systems) by an independent, calibrated examiner. The between-group treatment effect is estimated using ANCOVA with the 5-month value as the dependent variable, treatment group as a fixed factor, baseline value as a covariate, and jaw as an additional between-subject factor.
Baseline (T0) and 5 months after tooth extraction

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Midfacial mucosal level at 5 months
Ramy czasowe: Baseline (T0) and 5 months
Vertical position of the midfacial mucosal margin at 5 months (mm), assessed on superimposed intraoral surface scans. The between-group difference is estimated using ANCOVA with the 5-month value as dependent variable and the baseline value as covariate.
Baseline (T0) and 5 months
Horizontal ridge contour at 5 months
Ramy czasowe: Baseline (T0) and 5 months
Horizontal ridge contour at 5 months (mm) at 1, 3, and 5 mm apical to the baseline mucosal reference, assessed on superimposed intraoral surface scans. Baseline-adjusted analysis at each level.
Baseline (T0) and 5 months
Mucosal thickness at 5 months
Ramy czasowe: Baseline (T0) and 5 months
Mucosal thickness at 5 months (mm) at 1, 3, and 5 mm apical to the baseline mucosal reference. Baseline-adjusted analysis at each level
Baseline (T0) and 5 months
Volumetric soft tissue at 5 months
Ramy czasowe: Baseline (T0) and 5 months
Volumetric soft tissue measurement at 5 months (mm3) within the defined region of interest, assessed on superimposed intraoral surface scans. Baseline-adjusted analysis.
Baseline (T0) and 5 months
Alveolar hard tissue volume at 5 months
Ramy czasowe: Baseline (T0) and 5 months
Volumetric measurement of alveolar hard tissue at 5 months (mm3), assessed on superimposed CBCT data. Baseline-adjusted analysis.
Baseline (T0) and 5 months
Alveolar hard tissue contour at 5 months
Ramy czasowe: Baseline (T0) and 5 months
Linear measurement of alveolar hard tissue contour at 5 months (mm), assessed on superimposed CBCT data. Baseline-adjusted analysis.
Baseline (T0) and 5 months
Postoperative discomfort (VAS)
Ramy czasowe: 2 weeks and 4 weeks after tooth extraction
Postoperative discomfort assessed on a 100-mm visual analogue scale, ranging from 0 mm (no discomfort) to 100 mm (worst imaginable discomfort).
2 weeks and 4 weeks after tooth extraction
Patient satisfaction with function (VAS)
Ramy czasowe: 5 months
Patient-rated satisfaction with the function of the provisional restoration, assessed on a 100-mm visual analogue scale, ranging from 0 mm (completely unsatisfied) to 100 mm (completely satisfied).
5 months
Patient satisfaction with esthetics (VAS)
Ramy czasowe: 5 months
Patient-rated satisfaction with the esthetics of the provisional restoration, assessed on a 100-mm visual analogue scale, ranging from 0 mm (completely unsatisfied) to 100 mm (completely satisfied).
5 months
Patient satisfaction with comfort (VAS)
Ramy czasowe: 5 months
Patient-rated satisfaction with the comfort of the provisional restoration, assessed on a 100-mm visual analogue scale, ranging from 0 mm (completely unsatisfied) to 100 mm (completely satisfied).
5 months
Overall treatment satisfaction (VAS)
Ramy czasowe: 5 months
Patient-rated overall satisfaction with the treatment received, assessed on a 100-mm visual analogue scale, ranging from 0 mm (completely unsatisfied) to 100 mm (completely satisfied).
5 months
Willingness to undergo the same procedure again (VAS)
Ramy czasowe: 5 months
Patient-rated willingness to undergo the same procedure again, assessed on a 100-mm visual analogue scale, ranging from 0 mm (definitely not) to 100 mm (definitely yes).
5 months
Oral Health Impact Profile (OHIP-G14)
Ramy czasowe: Baseline (T0) and 5 months
German version of the Oral Health Impact Profile, 14-item version. Summary score range 0 to 56; higher scores indicate worse oral health-related quality of life.
Baseline (T0) and 5 months
Geriatric Oral Health Assessment Index (GOHAI)
Ramy czasowe: Baseline (T0) and 5 months
German version of the Geriatric Oral Health Assessment Index. Summary score range 12 to 60; higher scores indicate better oral health-related quality of life.
Baseline (T0) and 5 months
Adverse events and provisional-related complications
Ramy czasowe: Up to 5 months
Occurrence and rate of adverse events, including postoperative infection, impaired wound healing, soft tissue dehiscence, loss or displacement of the bone substitute or collagen matrix, allergic or hypersensitivity reactions, pressure-induced mucosal lesions, debonding of the fixed provisional restoration, or irritation related to the Essix provisional.
Up to 5 months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Śledczy

  • Główny śledczy: Nicole Schenk, Dr. med. dent., University of Bern, Department of Reconstructive Dentistry and Gerodontology
  • Krzesło do nauki: Martin Schimmel, Prof. Dr. med. dent., University of Bern, Department of Reconstructive Dentistry and Gerodontology
  • Dyrektor Studium: Emilio Couso-Queiruga, PD Dr. med. dent., University of Bern, Department of Oral Surgery and Stomatology

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

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 (Szacowany)

1 października 2026

Zakończenie podstawowe (Szacowany)

1 lutego 2029

Ukończenie studiów (Szacowany)

1 lutego 2029

Daty rejestracji na studia

Pierwszy przesłany

31 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

31 lipca 2026

Pierwszy wysłany (Rzeczywisty)

6 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

31 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • Pontic-Essix
  • 2026-01626 (Inny identyfikator: Swiss Ethics Committee (BASEC))

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Individual participant data will not be publicly shared. The informed consent and data protection framework of this trial do not provide for unrestricted public sharing of coded participant-level data. Aggregated study results will be published in a peer-reviewed journal and posted in the Swiss National Clinical Trials Portal (SNCTP) and on ClinicalTrials.gov in accordance with ClinO Art. 65a.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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