Ovate Pontic Versus Essix Provisional After Tooth Extraction and Alveolar Ridge Preservation (Pontic-Essix) (Pontic-Essix)
Socket Sealing With a Fixed Ovate Pontic Provisional Versus a Removable Provisional Following Tooth Extraction and Alveolar Ridge Preservation: A Randomized Controlled Trial
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Fase
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Nicole Schenk, Dr. med. dent.
- Telefonnummer: +41 31 684 06 35
- E-mail: nicole.schenk@unibe.ch
Undersøgelse Kontakt Backup
- Navn: Martin Schimmel, Prof. Dr. med. dent.
- Telefonnummer: +41 31 684 06 35
- E-mail: martin.schimmel@unibe.ch
Studiesteder
-
-
Canton of Bern
-
Bern, Canton of Bern, Schweiz, 3010
- University of Bern, Department of Reconstructive Dentistry and Gerodontology
-
Kontakt:
- Nicole Schenk, Dr. med. dent.
- Telefonnummer: +41 31 684 06 35
- E-mail: nicole.schenk@unibe.ch
-
-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: 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.
Andre navne:
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.
|
|
Aktiv 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.
Andre navne:
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Interproximal soft tissue height at 5 months
Tidsramme: 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
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Midfacial mucosal level at 5 months
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Efterforskere
Efterforskere
- Ledende efterforsker: Nicole Schenk, Dr. med. dent., University of Bern, Department of Reconstructive Dentistry and Gerodontology
- Studiestol: Martin Schimmel, Prof. Dr. med. dent., University of Bern, Department of Reconstructive Dentistry and Gerodontology
- Studieleder: Emilio Couso-Queiruga, PD Dr. med. dent., University of Bern, Department of Oral Surgery and Stomatology
Publikationer og nyttige links
Generelle publikationer
- Avila-Ortiz G, Gubler M, Romero-Bustillos M, Nicholas CL, Zimmerman MB, Barwacz CA. Efficacy of Alveolar Ridge Preservation: A Randomized Controlled Trial. J Dent Res. 2020 Apr;99(4):402-409. doi: 10.1177/0022034520905660. Epub 2020 Feb 12.
- Couso-Queiruga E, Garaicoa-Pazmino C, Fonseca M, Chappuis V, Gonzalez-Martin O, Avila-Ortiz G. Interproximal Soft Tissue Height Changes After Unassisted Socket Healing vs Alveolar Ridge Preservation Therapy. Int J Periodontics Restorative Dent. 2024;44(5):520-533. doi: 10.11607/prd.6809.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- Pontic-Essix
- 2026-01626 (Anden identifikator: Swiss Ethics Committee (BASEC))
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .