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

perjantai 31. heinäkuuta 2026 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Ei vielä rekrytointia

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

40

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Tutki yhteystietojen varmuuskopiointi

Opiskelupaikat

  • Sveitsi
    • Canton of Bern
      • Bern, Canton of Bern, Sveitsi, 3010
        • University of Bern, Department of Reconstructive Dentistry and Gerodontology
        • Ottaa yhteyttä:

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Yksittäinen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: 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.
Laite: Bio-Oss Collagen
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.
Muut nimet:
  • Fixed ovate pontic provisional
  • Removable Essix provisional with collagen matrix seal
Menettely: Fixed 3D-printed ovate pontic provisional restoration
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.
Active Comparator: 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.
Laite: Bio-Oss Collagen
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.
Muut nimet:
  • Fixed ovate pontic provisional
  • Removable Essix provisional with collagen matrix seal
Laite: Mucograft 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.
Menettely: Removable Essix provisional restoration
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.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Interproximal soft tissue height at 5 months
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Midfacial mucosal level at 5 months
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

University of Bern

Tutkijat

  • Päätutkija: Nicole Schenk, Dr. med. dent., University of Bern, Department of Reconstructive Dentistry and Gerodontology
  • Opintojen puheenjohtaja: Martin Schimmel, Prof. Dr. med. dent., University of Bern, Department of Reconstructive Dentistry and Gerodontology
  • Opintojohtaja: Emilio Couso-Queiruga, PD Dr. med. dent., University of Bern, Department of Oral Surgery and Stomatology

Julkaisuja ja hyödyllisiä linkkejä

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Yleiset julkaisut

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

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Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

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Ensimmäinen toimitettu, joka täytti QC-kriteerit

Perjantai 31. heinäkuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Torstai 6. elokuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Torstai 6. elokuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Perjantai 31. heinäkuuta 2026

Viimeksi vahvistettu

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Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • Pontic-Essix
  • 2026-01626 (Muu tunniste: Swiss Ethics Committee (BASEC))

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

EI

IPD-suunnitelman kuvaus

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.

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Ei

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

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