Tooth Loss / RehabilitationPontic-EssixNCT07748871
Ovate Pontic Versus Essix Provisional After Tooth Extraction and Alveolar Ridge Preservation (Pontic-Essix)
A study testing Bio-Oss Collagen, Mucograft Seal and Fixed 3D-printed ovate pontic provisional restoration in people with Tooth Loss / Rehabilitation and Tooth Extraction, run by University of Bern at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Loss / Rehabilitation, Tooth Extraction, Alveolar Bone Loss
- What is being tested?
- Bio-Oss Collagen, Mucograft Seal and Fixed 3D-printed ovate pontic provisional restoration
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2026to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
University of Bern, Department of Reconstructive Dentistry and Gerodontology
Bern, Canton of Bern, 3010
Nicole Schenk, Dr. med. dent., +41 31 684 06 35, nicole.schenk@unibe.ch
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Tooth Loss / Rehabilitation, Tooth Extraction, Alveolar Bone Loss, Alveolar Ridge Augmentation
- Being tested
- Bio-Oss Collagen, Mucograft Seal, Fixed 3D-printed ovate pontic provisional restoration, Removable Essix provisional restoration
- Keywords
- alveolar ridge preservation, ovate pontic, socket sealing, provisional restoration, interproximal soft tissue, papilla, digital superimposition, randomized controlled trial
- Medical subject headings
- Tooth Loss, Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio-Oss CollagenDevice
Also called Fixed ovate pontic provisional, Removable Essix provisional with collagen matrix seal
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 SealDevice
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 restorationProcedure or 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 restorationProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Fixed ovate pontic provisional | Experimental | 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. Receives: Device: Bio-Oss Collagen; Procedure: Fixed 3D-printed ovate pontic provisional restoration |
| Removable Essix provisional with collagen matrix seal | Active comparator | 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. Receives: Device: Bio-Oss Collagen; Device: Mucograft Seal; Procedure: Removable Essix provisional restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T0) and 5 months after tooth extraction
Secondary outcomes (15)
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.
Measured: Baseline (T0) and 5 months
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.
Measured: Baseline (T0) and 5 months
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
Measured: Baseline (T0) and 5 months
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.
Measured: Baseline (T0) and 5 months
Alveolar hard tissue volume at 5 months
Volumetric measurement of alveolar hard tissue at 5 months (mm3), assessed on superimposed CBCT data. Baseline-adjusted analysis.
Measured: Baseline (T0) and 5 months
Alveolar hard tissue contour at 5 months
Linear measurement of alveolar hard tissue contour at 5 months (mm), assessed on superimposed CBCT data. Baseline-adjusted analysis.
Measured: Baseline (T0) and 5 months
Postoperative discomfort (VAS)
Postoperative discomfort assessed on a 100-mm visual analogue scale, ranging from 0 mm (no discomfort) to 100 mm (worst imaginable discomfort).
Measured: 2 weeks and 4 weeks after tooth extraction
Patient satisfaction with function (VAS)
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).
Measured: 5 months
Patient satisfaction with esthetics (VAS)
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).
Measured: 5 months
Patient satisfaction with comfort (VAS)
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).
Measured: 5 months
Overall treatment satisfaction (VAS)
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).
Measured: 5 months
Willingness to undergo the same procedure again (VAS)
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).
Measured: 5 months
Oral Health Impact Profile (OHIP-G14)
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.
Measured: Baseline (T0) and 5 months
Geriatric Oral Health Assessment Index (GOHAI)
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.
Measured: Baseline (T0) and 5 months
Adverse events and provisional-related complications
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.
Measured: Up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tooth Loss / RehabilitationStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, open-label, confirmatory, randomized controlled trial with two parallel groups and 1:1 allocation. Adaptive design with an internal pilot phase (n=20) and blinded sample size re-estimation based on the residual variance of the primary endpoint, up to a predefined maximum of 40 participants.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole Schenk, Dr. med. dent., Principal investigator, University of Bern, Department of Reconstructive Dentistry and GerodontologyMartin Schimmel, Prof. Dr. med. dent., Study chair, University of Bern, Department of Reconstructive Dentistry and GerodontologyEmilio Couso-Queiruga, PD Dr. med. dent., Study director, University of Bern, Department of Oral Surgery and Stomatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748871
- Sponsor's protocol ID
- Pontic-Essix
- Other IDs
- 2026-01626
- Acronym
- Pontic-Essix
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 32050833Couso-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.
PubMed 37471159
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Socket Sealing With a Fixed Ovate Pontic Provisional Versus a Removable Provisional Following Tooth Extraction and Alveolar Ridge Preservation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07748871
- Acronym / sponsor ID
- Pontic-Essix / Pontic-Essix
- Conditions
- Tooth Loss / Rehabilitation, Tooth Extraction, Alveolar Bone Loss, Alveolar Ridge Augmentation
- Keywords
- alveolar ridge preservation, ovate pontic, socket sealing, provisional restoration, interproximal soft tissue, papilla, digital superimposition, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-center, open-label, confirmatory, randomized controlled trial with two parallel groups and 1:1 allocation. Adaptive design with an internal pilot phase (n=20) and blinded sample size re-estimation based on the residual variance of the primary endpoint, up to a predefined maximum of 40 participants.
| Arm | Type | Receives |
|---|---|---|
| Fixed ovate pontic provisional | Experimental | Device: Bio-Oss Collagen, Procedure: Fixed 3D-printed ovate pontic provisional restorationFollowing 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 comparator | Device: Bio-Oss Collagen, Device: Mucograft Seal, Procedure: Removable Essix provisional restorationFollowing 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bio-Oss CollagenAlso: Fixed ovate pontic provisional, Removable Essix provisional with collagen matrix sealDeproteinized 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. | Device | Fixed ovate pontic provisional, Removable Essix provisional with collagen matrix seal |
| Mucograft SealPatient-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 | Removable Essix provisional with collagen matrix seal |
| Fixed 3D-printed ovate pontic provisional restorationPatient-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 or surgery | Fixed ovate pontic provisional |
| Removable Essix provisional restorationPatient-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. | Procedure or surgery | Removable Essix provisional with collagen matrix seal |
Primary outcome
Interproximal soft tissue height at 5 months
Time frame: 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.
15 secondary outcomes
Midfacial mucosal level at 5 months
Time frame: Baseline (T0) and 5 months
Horizontal ridge contour at 5 months
Time frame: Baseline (T0) and 5 months
Mucosal thickness at 5 months
Time frame: Baseline (T0) and 5 months
Volumetric soft tissue at 5 months
Time frame: Baseline (T0) and 5 months
Alveolar hard tissue volume at 5 months
Time frame: Baseline (T0) and 5 months
Alveolar hard tissue contour at 5 months
Time frame: Baseline (T0) and 5 months
Postoperative discomfort (VAS)
Time frame: 2 weeks and 4 weeks after tooth extraction
Patient satisfaction with function (VAS)
Time frame: 5 months
Patient satisfaction with esthetics (VAS)
Time frame: 5 months
Patient satisfaction with comfort (VAS)
Time frame: 5 months
Overall treatment satisfaction (VAS)
Time frame: 5 months
Willingness to undergo the same procedure again (VAS)
Time frame: 5 months
Oral Health Impact Profile (OHIP-G14)
Time frame: Baseline (T0) and 5 months
Geriatric Oral Health Assessment Index (GOHAI)
Time frame: Baseline (T0) and 5 months
Adverse events and provisional-related complications
Time frame: Up to 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Background: PubMed 32050833Avila-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.
- Background: PubMed 37471159Couso-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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicole Schenk, Dr. med. dent. principal investigator
University of Bern, Department of Reconstructive Dentistry and Gerodontology
Martin Schimmel, Prof. Dr. med. dent. study chair
University of Bern, Department of Reconstructive Dentistry and Gerodontology
Emilio Couso-Queiruga, PD Dr. med. dent. study director
University of Bern, Department of Oral Surgery and Stomatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bio-Oss Collagen, Mucograft Seal and Fixed 3D-printed ovate pontic provisional restoration in people with Tooth Loss / Rehabilitation and Tooth Extraction, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Schenk, Dr. med. dent. (+41 31 684 06 35, nicole.schenk@unibe.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interproximal soft tissue height at 5 months (time frame: Baseline (T0) and 5 months after tooth extraction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07748871, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.