Bone RegenerationNCT04843488
Effectiveness of Different Membrane Applications in Vertical Ridge Augmentation
A study testing Guided bone regeneration with a PTFE membrane and Guided bone regeneration with a PTFE+collagen membrane in people with Bone Regeneration and Dental Implants, run by Urban Regeneration Institute at 1 site in Hungary.
Trial summary
This randomized clinical trial (RCT) study investigates if there is any difference in absolute vertical bone gain between perforated dense-polytetrafluroethylene (d-PTFE) mesh vs perforated d-PTFE mesh covered with a native collagen membrane. The primary endpoint is absolute vertical bone gain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Regeneration, Dental Implants, Polytetrafluoroethylene
- What is being tested?
- Guided bone regeneration with a PTFE membrane and Guided bone regeneration with a PTFE+collagen membrane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHungary
- Study dates
- 15 Apr 2021to 2 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Partially edentulous patients requiring vertical and horizontal ridge augmentation
- patients agrees with conditions of the study and sign consent
Who cannot join
- Insufficient oral hygiene
- Smoking
- Alcohol or Drug abuse
- acute local or systemic infections
- uncontrolled diabetes or other metabolic disease
- severe hepatic or renal disfunction
Show all 9Show fewer
- autoimmune disease
- radiotherapy in the last 5 years
- patients receiving immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Different Membrane Applications (Perforated Polytetrafluroethylene (PTFE) vs. Perforated PTFE+ Collagen Membrane) in Vertical Ridge Augmentation - Randomized Clinical Trial
This randomized clinical trial (RCT) study investigates if there is any difference in absolute vertical bone gain between perforated dense-polytetrafluroethylene (d-PTFE) mesh vs perforated d-PTFE mesh covered with a native collagen membrane.
The primary endpoint is absolute vertical bone gain. The secondary endpoints are regeneration rate, complications rate, and pseudoperiosteum formation.
- Conditions
- Bone Regeneration, Dental Implants, Polytetrafluoroethylene
- Being tested
- Guided bone regeneration with a PTFE membrane, Guided bone regeneration with a PTFE+collagen membrane
- Keywords
- Guided Bone Regeneration, Vertical Ridge Regeneration, PTFE membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided bone regeneration with a PTFE membraneProcedure or surgery
Xenograft bovine spongious bone substitute mixed with autogenous intraorally harvested particulated bone is used and spatially contained with a PTFE membrane secured with Ti pins and screws.
Guided bone regeneration with a PTFE+collagen membraneProcedure or surgery
Xenograft bovine spongious bone substitute mixed with autogenous intraorally harvested particulated bone is used and spatially contained with a PTFE membrane secured with Ti pins and screws and covered with a Collagen membrane subsequently.
| Study group | Role | What they receive |
|---|---|---|
| Ridge Augmentation with a perforate PTFE mesh | Active comparator | Vertical and horizontal ridge augmentation will be performed using d-PTFE mesh. The graft material is autograft mixed with a xenograft in a 1:1 ratio. Receives: Procedure: Guided bone regeneration with a PTFE membrane |
| Ridge Augmentation with a perforate PTFE mesh covered with a collagen membrane | Experimental | Vertical and horizontal ridge augmentation will be performed using d-PTFE mesh. The mesh will be covered with a native collagen membrane. The graft material is autograft mixed with a xenograft in a 1:1 ratio. Receives: Procedure: Guided bone regeneration with a PTFE+collagen membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate
intrasurgical complications such as flap perforation, mesh exposure, postoperative infection, neurosensory disturbance,
Measured: 9 months
Bone gain
Vertical and horizontal bone gain measured
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start15 Apr 2021
- Primary completion12 Nov 2022
- Study completion2 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bone RegenerationStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Urban Regeneration Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Szeged University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843488
- Sponsor's protocol ID
- PTFE1
- Status last verified
- Jun 2024
- First submitted
- 8 Apr 2021
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Urban IA, Montero E, Monje A, Sanz-Sanchez I. Effectiveness of vertical ridge augmentation interventions: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:319-339. doi: 10.1111/jcpe.13061.
PubMed 30667522Urban IA, Monje A, Lozada J, Wang HL. Principles for Vertical Ridge Augmentation in the Atrophic Posterior Mandible: A Technical Review. Int J Periodontics Restorative Dent. 2017 Sep/Oct;37(5):639-645. doi: 10.11607/prd.3200.
PubMed 28817126Plonka AB, Urban IA, Wang HL. Decision Tree for Vertical Ridge Augmentation. Int J Periodontics Restorative Dent. 2018 Mar/Apr;38(2):269-275. doi: 10.11607/prd.3280.
PubMed 29447321Urban IA, Monje A, Lozada JL, Wang HL. Long-term Evaluation of Peri-implant Bone Level after Reconstruction of Severely Atrophic Edentulous Maxilla via Vertical and Horizontal Guided Bone Regeneration in Combination with Sinus Augmentation: A Case Series with 1 to 15 Years of Loading. Clin Implant Dent Relat Res. 2017 Feb;19(1):46-55. doi: 10.1111/cid.12431. Epub 2016 May 30.
PubMed 27238406Urban IA, Monje A, Nevins M, Nevins ML, Lozada JL, Wang HL. Surgical Management of Significant Maxillary Anterior Vertical Ridge Defects. Int J Periodontics Restorative Dent. 2016 May-Jun;36(3):329-37. doi: 10.11607/prd.2644.
PubMed 27100802Urban IA, Serroni M, Dias DR, Barath Z, Forster A, Araujo TG, Saleh MHA, Cucchi A, Ravida A. Impact of Collagen Membrane in Vertical Ridge Augmentation Using Ti-Reinforced PTFE Mesh: A Randomised Controlled Trial. J Clin Periodontol. 2025 Apr;52(4):575-588. doi: 10.1111/jcpe.14129. Epub 2025 Feb 14.
PubMed 39953742
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Different Membrane Applications (Perforated Polytetrafluroethylene (PTFE) vs. Perforated PTFE+ Collagen Membrane) in Vertical Ridge Augmentation - Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04843488
- Acronym / sponsor ID
- PTFE1
- Conditions
- Bone Regeneration, Dental Implants, Polytetrafluoroethylene
- Keywords
- Guided Bone Regeneration, Vertical Ridge Regeneration, PTFE membrane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Urban Regeneration InstituteUniversity, hospital or other
- Collaborators
- Szeged University
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 12 Nov 2022 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 13 Apr 2021 (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 clinical trial (RCT) study investigates if there is any difference in absolute vertical bone gain between perforated dense-polytetrafluroethylene (d-PTFE) mesh vs perforated d-PTFE mesh covered with a native collagen membrane.
The primary endpoint is absolute vertical bone gain. The secondary endpoints are regeneration rate, complications rate, and pseudoperiosteum formation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ridge Augmentation with a perforate PTFE mesh | Active comparator | Procedure: Guided bone regeneration with a PTFE membraneVertical and horizontal ridge augmentation will be performed using d-PTFE mesh. The graft material is autograft mixed with a xenograft in a 1:1 ratio. |
| Ridge Augmentation with a perforate PTFE mesh covered with a collagen membrane | Experimental | Procedure: Guided bone regeneration with a PTFE+collagen membraneVertical and horizontal ridge augmentation will be performed using d-PTFE mesh. The mesh will be covered with a native collagen membrane. The graft material is autograft mixed with a xenograft in a 1:1 ratio. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Partially edentulous patients requiring vertical and horizontal ridge augmentation
- patients agrees with conditions of the study and sign consent
Key exclusion criteria (9 listed)
- Insufficient oral hygiene
- Smoking
- Alcohol or Drug abuse
- acute local or systemic infections
- uncontrolled diabetes or other metabolic disease
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 |
|---|---|---|
| Guided bone regeneration with a PTFE membraneXenograft bovine spongious bone substitute mixed with autogenous intraorally harvested particulated bone is used and spatially contained with a PTFE membrane secured with Ti pins and screws. | Procedure or surgery | Ridge Augmentation with a perforate PTFE mesh |
| Guided bone regeneration with a PTFE+collagen membraneXenograft bovine spongious bone substitute mixed with autogenous intraorally harvested particulated bone is used and spatially contained with a PTFE membrane secured with Ti pins and screws and covered with a Collagen membrane subsequently. | Procedure or surgery | Ridge Augmentation with a perforate PTFE mesh covered with a collagen membrane |
Primary outcome
Complication rate
Time frame: 9 months
intrasurgical complications such as flap perforation, mesh exposure, postoperative infection, neurosensory disturbance,
Bone gain
Time frame: 9 months
Vertical and horizontal bone gain measured
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Background: PubMed 30667522Urban IA, Montero E, Monje A, Sanz-Sanchez I. Effectiveness of vertical ridge augmentation interventions: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:319-339. doi: 10.1111/jcpe.13061.
- Background: PubMed 28817126Urban IA, Monje A, Lozada J, Wang HL. Principles for Vertical Ridge Augmentation in the Atrophic Posterior Mandible: A Technical Review. Int J Periodontics Restorative Dent. 2017 Sep/Oct;37(5):639-645. doi: 10.11607/prd.3200.
- Background: PubMed 29447321Plonka AB, Urban IA, Wang HL. Decision Tree for Vertical Ridge Augmentation. Int J Periodontics Restorative Dent. 2018 Mar/Apr;38(2):269-275. doi: 10.11607/prd.3280.
- Background: PubMed 27238406Urban IA, Monje A, Lozada JL, Wang HL. Long-term Evaluation of Peri-implant Bone Level after Reconstruction of Severely Atrophic Edentulous Maxilla via Vertical and Horizontal Guided Bone Regeneration in Combination with Sinus Augmentation: A Case Series with 1 to 15 Years of Loading. Clin Implant Dent Relat Res. 2017 Feb;19(1):46-55. doi: 10.1111/cid.12431. Epub 2016 May 30.
- Background: PubMed 27100802Urban IA, Monje A, Nevins M, Nevins ML, Lozada JL, Wang HL. Surgical Management of Significant Maxillary Anterior Vertical Ridge Defects. Int J Periodontics Restorative Dent. 2016 May-Jun;36(3):329-37. doi: 10.11607/prd.2644.
- Derived from this study: PubMed 39953742Urban IA, Serroni M, Dias DR, Barath Z, Forster A, Araujo TG, Saleh MHA, Cucchi A, Ravida A. Impact of Collagen Membrane in Vertical Ridge Augmentation Using Ti-Reinforced PTFE Mesh: A Randomised Controlled Trial. J Clin Periodontol. 2025 Apr;52(4):575-588. doi: 10.1111/jcpe.14129. Epub 2025 Feb 14.
- Individual participant dataSharing planned: No
Related trials for Bone Regeneration
Not yet recruitingEarly Phase 1
The Efficacy of Exosomes Combined With Synthetic Bone Graft for the Treatment of Periodontal Intra-bony Defects
Intra-Bony Defects in Periodontitis Patients
Active, not recruitingObservational study
Long-Term Stability of Soft and Hard Tissues After Guided Bone Regeneration in the Maxillary Anterior Region
Alveolar Bone Deficiency
Recruiting
Guided Bone Regeneration Using Polydioxanone (PDO) Membrane in Sockets After Tooth Extraction
Surgery, Oral
Not yet recruiting
Comparison of Three Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
Not yet recruitingPhase 1/2
Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.
Alveolar Ridge Augmentation, Bone Substitutes
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided bone regeneration with a PTFE membrane and Guided bone regeneration with a PTFE+collagen membrane in people with Bone Regeneration and Dental Implants, run by Urban Regeneration Institute at 1 site in Hungary.
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 2 inclusion and 9 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: finished, as of the sponsor's last update on 4 Dec 2024. 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 Hungary. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication rate (time frame: 9 months). The study lists 2 primary outcomes in all. 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 NCT04843488, which also lists 6 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 4 Dec 2024.