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
2 other identifiers
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2026
CompletedFirst Posted
Study publicly available on registry
August 6, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2029
Study Completion
Last participant's last visit for all outcomes
February 1, 2029
August 6, 2026
July 1, 2026
2.3 years
July 31, 2026
July 31, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Interproximal soft tissue height at 5 months
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
Secondary Outcomes (15)
Midfacial mucosal level at 5 months
Baseline (T0) and 5 months
Horizontal ridge contour at 5 months
Baseline (T0) and 5 months
Mucosal thickness at 5 months
Baseline (T0) and 5 months
Volumetric soft tissue at 5 months
Baseline (T0) and 5 months
Alveolar hard tissue volume at 5 months
Baseline (T0) and 5 months
- +10 more secondary outcomes
Study Arms (2)
Fixed ovate pontic provisional
EXPERIMENTALFollowing 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.
Removable Essix provisional with collagen matrix seal
ACTIVE COMPARATORFollowing 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.
Interventions
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.
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 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Bern, Department of Reconstructive Dentistry and Gerodontology
Bern, Canton of Bern, 3010, Switzerland
Related Publications (2)
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.
PMID: 32050833BACKGROUNDCouso-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.
PMID: 37471159BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicole Schenk, Dr. med. dent.
University of Bern, Department of Reconstructive Dentistry and Gerodontology
- STUDY CHAIR
Martin Schimmel, Prof. Dr. med. dent.
University of Bern, Department of Reconstructive Dentistry and Gerodontology
- STUDY DIRECTOR
Emilio Couso-Queiruga, PD Dr. med. dent.
University of Bern, Department of Oral Surgery and Stomatology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The trial is open-label for participants and treating clinicians because the two provisional restorations are clinically distinguishable. The examiner performing the digital analysis of intraoral surface scans and CBCT data is independent of the clinical treatment and is blinded to group allocation; outcome data are coded before analysis.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2026
First Posted
August 6, 2026
Study Start (Estimated)
October 1, 2026
Primary Completion (Estimated)
February 1, 2029
Study Completion (Estimated)
February 1, 2029
Last Updated
August 6, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share
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.