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

ConditionsTooth Loss / RehabilitationTooth ExtractionAlveolar Bone LossAlveolar Ridge Augmentation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Bern

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bio-Oss Collagen

    Device

    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.

  • Mucograft Seal

    Device

    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.

  • Fixed 3D-printed ovate pontic provisional restoration

    Procedure/Surgery

    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.

  • Removable Essix provisional restoration

    Procedure/Surgery

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Fixed ovate pontic provisionalExperimental treatment 2 interventions
Group B: Removable Essix provisional with collagen matrix sealActive comparator 3 interventions

Trial outcomes

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.

Time frame
Baseline (T0) and 5 months after tooth extraction

Secondary outcomes

1

Midfacial mucosal level at 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.

Time frame
Baseline (T0) and 5 months
2

Horizontal ridge contour at 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.

Time frame
Baseline (T0) and 5 months
3

Mucosal thickness at 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

Time frame
Baseline (T0) and 5 months
4

Volumetric soft tissue at 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.

Time frame
Baseline (T0) and 5 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Bern

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: