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

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.

Conditions

• Tooth Loss / Rehabilitation
• Tooth Extraction
• Alveolar Bone Loss
• Alveolar Ridge Augmentation

Interventions

DEVICE

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.

DEVICE

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.

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

• University of Bern

  lead OTHER

Principal Investigators

• Nicole Schenk, Dr. med. dent. · University of Bern, Department of Reconstructive Dentistry and Gerodontology

• Martin Schimmel, Prof. Dr. med. dent. · University of Bern, Department of Reconstructive Dentistry and Gerodontology

• Emilio Couso-Queiruga, PD Dr. med. dent. · University of Bern, Department of Oral Surgery and Stomatology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-10-31

Primary Completion

2029-02-28

Completion

2029-02-28

Countries

• Switzerland

Study Locations