Alveolar Bone ResorptionPhase 3VARGASNCT06242782
Vertical Ridge Augmentation Strategies
A Phase 3 study testing VRA + d-PTFE membrane, VRA + e-PTFE membrane and VRA + customised Ti-mesh in people with Alveolar Bone Resorption and Alveolar Ridge Trauma, run by University College, London.
Trial summary
Guided Bone Regeneration (GBR) is an invaluable and beneficial surgical technique adopted when there is the need to augment an alveolar atrophy. Strong clinical and histologic evidence exists on the effectiveness and predictability of GBR in bone augmentation of ridge deficiencies. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alveolar Bone Resorption, Alveolar Ridge Trauma, Alveolar Bone Loss
- What is being tested?
- VRA + d-PTFE membrane, VRA + e-PTFE membrane and VRA + customised Ti-mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Feb 2030
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Partially edentulous with a ridge that shows at least 3mm vertical bone deficiency;
- Females of childbearing potential and males agree to use an effective method of contraception from the time consent is signed until treatment discontinuation.
- Females of childbearing potential have a negative pregnancy test within 7 days prior to being registered. Participants are considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
- Willing and able to provide written informed consent.
Who cannot join
- Comorbidities (or regular use of medications)
- History of bone augmentation or implant placement at the area of interest
- Females who are pregnant, planning pregnancy or breastfeeding
- Regular use of analgesic or antibiotics within 1 month before entering the study
- Disclosed smoking (including electronic cigarettes) or drinking over 14 alcoholic units per week
- Active oral diseases or poor oral hygiene (defined by full mouth dental plaque scores greater than 25%)
- Suspected or documented titanium allergy or intolerance
- Concurrent and/or recent involvement in other research that is likely to interfere with the intervention within last 3 months of study enrolment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Vertical Ridge Augmentation Strategies: An Adaptive Randomised Controlled Clinical Trial
Guided Bone Regeneration (GBR) is an invaluable and beneficial surgical technique adopted when there is the need to augment an alveolar atrophy. Strong clinical and histologic evidence exists on the effectiveness and predictability of GBR in bone augmentation of ridge deficiencies. On the other hand, it is well known that GBR remains a challenge as in the most extreme cases, it is considered a highly technique-sensitive surgical procedure.
Whilst there are numerous reviews which report the average incidence of complications in GBR, there is still insufficient evidence and manuscripts reporting a direct correlation between a specific biomaterial (membrane or scaffold) and observed complications. Only one recent systematic review and meta-analysis focused on wound healing complications following GBR for ridge augmentation procedures. Authors explored the complication rate based on the membrane type and on the timing of the first sign of soft tissue complications following bone augmentation procedures. They reported a complication rate of 17% of the overall soft tissue complications, including membrane exposure, soft tissue dehiscence, and acute infection (abscess). This estimate is consistent with that reported (12%) in a more recent systematic appraisal of the evidence on all types of complications in GBR (3). However, when horizontal augmentation procedures were reviewed, a higher rate (21%) of complications was reported within the first 18 months of a GBR procedure. This estimate was inclusive of all possible biologic complications following GBR whilst the rate of membrane exposure was of 23%.
Read more
Vertical bone augmentation represents one of the most challenging bone regenerative procedures in surgical dentistry. This is because of the inherent difficulties of the surgical procedure and the high risk of complications. The primary aim of this procedure is to recreate alveolar bone in a vertical direction (without the support of any pre-existing walls) and enable recreation of a more favourable anatomy for the restoration of the edentulous site.
Evidence on a variety of treatment options has been produced over the last 15 years including distraction osteogenesis, onlay bone grafting, and vertical ridge augmentation (VRA). Systematic reviews evaluating the efficacy of different surgical procedures for VRA either in a staged or a simultaneous fashion, reported a range of vertical bone gain of 2-8 mm. This gain was gradually lost (1.27 to 2.0mm) between 1 to 7 years post-surgery and a wide range of complications (0- 45.5%) has been reported.
The aim of this study is to assess and compare incidence of complications and percentage of vertical bone gain when using four different barrier membranes in combination with 50/50 autogenous and xenogenous bone material in VRA procedures. Secondary aims will be to evaluate and compare early and late soft tissue wound healing, gingival microvasculature and structure, patient reported outcomes and the prevalence of need for further bone augmentation and need for soft tissue grafting. Additionally, this study will also aim to assess and compare histomorphometry and histochemistry analyses of core biopsies obtained before implant placement between the four different barrier membranes.
Read the detailed description
This is a single centre non-inferiority adaptive randomised controlled clinical trial. The primary aim of this study will be:
To assess the clinical composite outcome (incidence of complications and percentage of vertical bone gain) of vertical alveolar bone grafting procedures in patients with vertical ridge deficiencies prior to dental implant placement, using a mix of autogenous and xenogenic particulate bone materials in combination with four different barrier membranes (Titanium (Ti)-Reinforced d-Polytetrafluoroethylene (PTFE) membrane [control group], Ti-Reinforced e-PTFE Membrane, 3D printed Ti-mesh and Reinforced PTFE Mesh (RPM)).
Secondary aims are:
- To assess and compare soft tissue wound healing and vascularization using Laser Doppler Flowmetry (LDF) between tests and control.
- To assess and compare gingival microvasculature and structure in vivo using Optical Coherence Tomography (OCT) between tests and control.
- To compare prevalence of the need for further bone grafting at the time of implant placement between tests and control.
- To compare prevalence of the need of soft tissue grafting at second stage surgery between tests and controls.
- To assess and compare patient reported outcomes using the EuroQol five-dimension (EQ-5D-5L) scale and the short-form Oral Health Impact Profile (OHIP-14) between tests and control.
- To assess and compare histomorphometry and histochemistry analyses of core biopsies obtained from a sample of 5 participants from each group before implant placement between tests and control.
Patients in need of vertical ridge augmentation prior to dental implant placement will be recruited to take part in this study and will be randomised into one of the following groups receiving different interventions:
- VRA using a 50/50 particulate bone mix (xenograft+ autograft) + Ti-Reinforced d- PTFE membrane (Positive Control)
- VRA using a 50/50 particulate bone mix (xenograft+ autograft) + Ti-Reinforced e-PTFE membrane (Test 1).
- VRA using a 50/50 particulate bone mix (xenograft+ autograft) + 3D printed Titanium mesh (Test 2).
- VRA using a 50/50 particulate bone mix (xenograft+ autograft) + Reinforced PTFE mesh (Test 3)
One-hundreds and forty-eight (148) participants meeting inclusion/exclusion criteria and who consent to this study will undergo a baseline visit assessment (visit 2) in which they will have a comprehensive oral assessment, radiographic assessment of alveolar defect using Cone Beam CT and supportive periodontal therapy. After randomisation to either Tests (1-3) or Control Groups, each group will undergo a VRA procedure as randomised (visit 3). All patients will be re-examined at 1, 3, 7, 15, 30, 60 and 120 days (visits 4-10, respectively) after the surgical augmentation. At each assessment, clinical examination, soft tissue imaging measures and saliva collections will be performed. Additionally, supportive periodontal therapy will be provided to all participants at the 120 days post augmentations visit. All participants will then undergo dental Implants placement after 180 days (visit 11). Participants will then be followed at 7, 15, 30,90, 120, 180 and 365 days (visits 12-18) after dental implant placement. The 90 days post implantation visit will include supportive periodontal therapy while the 120 days visit will involve the placement of dental implant prosthetic components for all participants.
Statistical methodology and analysis:
Primary and secondary outcomes analysis:
Continuous data are displayed as mean and standard deviation whilst categorical variables will be reported as percentages and prevalence. All participants randomized to test or control will be included in final analyses. Analysis will be performed using last observation carrying forward and as intent to treat population. Secondarily, per protocol analysis will also be performed. Data will be entered in an electronic spreadsheet and checked/proofed for any errors. All data will be loaded in the appropriate software for analysis. The primary outcome assessment will be assessed by analysis of co-variance model. Age, gender, body mass index and ethnicity will be included as principal covariates. Pair-wise comparison and between groups differences will be calculated using Tukey corrections.
All secondary endpoints will be analysed in a similar fashion. Significance will be set to be at p ≤ 0.05. Adverse events analysis will also be performed between study groups at study visits. Serial changes in imaging variables will be analysed with analysis of variance for repeated measures using a conservative F-test (Greenhouse-Geisser correction). If a treatment by time interaction will be found, pair-wise comparisons will be performed (Bonferroni-Holm adjustment).
Sensitivity and other planned analyses:
In this trial, investigators will perform some types of the sensitivity analysis, including non-statistical and statistical analyses. The sensitivity analysis that investigators will be including are impact of non-compliance/protocol deviation, impact of missing data, impact of competing risk in analysis of composites outcomes, impact of baseline imbalance, and finally, related to statistical analysis is impact of different assumptions underlying statistical model. The option plan for the condition related to non-compliance/protocol deviation are intention-to-treat (ITT) analysis; as per protocol analysis; and as-treated analysis.
- Conditions
- Alveolar Bone Resorption, Alveolar Ridge Trauma, Alveolar Bone Loss, Complication of Surgical Procedure
- Being tested
- VRA + d-PTFE membrane, VRA + e-PTFE membrane, VRA + customised Ti-mesh, VRA + RPM
- Keywords
- Vertical Ridge Augmentation, Vertical Bone Augmentation, Alveolar Bone Grafting
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRA + d-PTFE membraneProcedure or surgery
VRA using a 50/50 particulate bone mix (xenograft+ autograft) + Ti-Reinforced d-PTFE membrane
VRA + e-PTFE membraneProcedure or surgery
VRA using a 50/50 particulate bone mix (xenograft+ autograft) + Ti-Reinforced e-PTFE membrane
VRA + customised Ti-meshProcedure or surgery
VRA using a 50/50 particulate bone mix (xenograft+ autograft) + 3D printed Titanium mesh
VRA + RPMProcedure or surgery
VRA using a 50/50 particulate bone mix (xenograft+ autograft) + Reinforced PTFE mesh
| Study group | Role | What they receive |
|---|---|---|
| Positive Control | Active comparator | VRA using Ti-Reinforced d-PTFE membrane Receives: Procedure: VRA + d-PTFE membrane |
| Test 1 | Experimental | VRA using Ti-Reinforced e-PTFE membrane Receives: Procedure: VRA + e-PTFE membrane |
| Test 2 | Experimental | VRA using 3D printed Titanium mesh Receives: Procedure: VRA + customised Ti-mesh |
| Test 3 | Experimental | VRA using Reinforced PTFE mesh Receives: Procedure: VRA + RPM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complications
Measured by clinical observation/examination at each follow up visit following VRA surgery.
Measured: Baseline visit (day 0) and follow up visits (at days 1, 4(±1), 7(±1), 15(±1), 30(±3), 60(±7) and 120(±7) post surgical VRA and at days 7(±1), 15(±1), 30(±7), 90(±7), 120(±7), 180 (±14) and 365 (±14) post dental implant placement
Percentage of vertical bone gain
Measured on cone beam computed tomography (CBCT).
Measured: At baseline (before surgical VRA) and at time of dental implant(s) placement (not earlier than 180 days post surgical VRA)
Secondary outcomes (8)
Soft tissue vascularization and wound healing
Measured by Laser Doppler Flowmetry (LDF).
Measured: Baseline visit (day 0) and follow up visits (at days 1, 4(±1), 7(±1), 15(±1), 30(±3), 60(±7) and 120(±7) post surgical VRA and at days 7(±1), 15(±1), 30(±7), 90(±7), 120(±7), 180 (±14) and 365 (±14) post dental implant placement
Gingival microvasculature and structure in vivo
Measured by Optical Coherence Tomography (OCT)
Measured: Baseline visit (day 0) and follow up visits (at days 1, 4(±1), 7(±1), 15(±1), 30(±3), 60(±7) and 120(±7) post surgical VRA and at days 7(±1), 15(±1), 30(±7), 90(±7), 120(±7), 180 (±14) and 365 (±14) post dental implant placement
Need for additional bone grafting
Measured: At time of dental implant(s) placement (not earlier than 180 days post surgical VRA)
Need of soft tissue grafting
Measured: At time of dental implant(s) placement (not earlier than 180 days post surgical VRA)
Patient reported outcome measures
Using the 5-level EQ-5D (EQ-5D-5L). The EQ-5D-5L scores can range from <0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.
Measured: Baseline visit (day 0) and follow up visits (at days 1, 4(±1), 7(±1), 15(±1), 30(±3), 60(±7) and 120(±7) post surgical VRA and at days 7(±1), 15(±1), 30(±7), 90(±7), 120(±7), 180 (±14) and 365 (±14) post dental implant placement
Patient reported outcome measures
Using the short-form Oral Health Impact Profile (OHIP-14). The OHIP-14 scores can range from 0 to 56. Higher scores indicate worse and lower scores indicate better Oral Health Related Quality of Life.
Measured: Baseline visit (day 0) and follow up visits (at days 1, 4(±1), 7(±1), 15(±1), 30(±3), 60(±7) and 120(±7) post surgical VRA and at days 7(±1), 15(±1), 30(±7), 90(±7), 120(±7), 180 (±14) and 365 (±14) post dental implant placement
Histomorphometry analysis
Using core biopsies obtained from a sample of 5 participants from each group
Measured: At time of dental implant(s) placement (not earlier than 180 days post surgical VRA)
Histochemistry analysis
Using core biopsies obtained from a sample of 5 participants from each group
Measured: At time of dental implant(s) placement (not earlier than 180 days post surgical VRA)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study startFeb 2024 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionFeb 2030 (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 Alveolar Bone ResorptionStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco D'Aiuto, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242782
- Sponsor's protocol ID
- IRAS ID 297914
- Other IDs
- IRAS ID 297914, EDGE ID 144889
- Acronym
- VARGAS
- Status last verified
- Feb 2024
- First submitted
- 5 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Could be available upon reasonable request
Publications
Alotaibi FF, Rocchietta I, Buti J, D'Aiuto F. Comparative evidence of different surgical techniques for the management of vertical alveolar ridge defects in terms of complications and efficacy: A systematic review and network meta-analysis. J Clin Periodontol. 2023 Nov;50(11):1487-1519. doi: 10.1111/jcpe.13850. Epub 2023 Jul 26.
PubMed 37495541Rocchietta I, Simion M, Hoffmann M, Trisciuoglio D, Benigni M, Dahlin C. Vertical Bone Augmentation with an Autogenous Block or Particles in Combination with Guided Bone Regeneration: A Clinical and Histological Preliminary Study in Humans. Clin Implant Dent Relat Res. 2016 Feb;18(1):19-29. doi: 10.1111/cid.12267. Epub 2015 Jan 27.
PubMed 25622713
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vertical Ridge Augmentation Strategies: An Adaptive Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06242782
- Acronym / sponsor ID
- VARGAS / IRAS ID 297914
- Conditions
- Alveolar Bone Resorption, Alveolar Ridge Trauma, Alveolar Bone Loss, Complication of Surgical Procedure
- Keywords
- Vertical Ridge Augmentation, Vertical Bone Augmentation, Alveolar Bone Grafting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 5 Feb 2024 (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.
Guided Bone Regeneration (GBR) is an invaluable and beneficial surgical technique adopted when there is the need to augment an alveolar atrophy. Strong clinical and histologic evidence exists on the effectiveness and predictability of GBR in bone augmentation of ridge deficiencies. On the other hand, it is well known that GBR remains a challenge as in the most extreme cases, it is considered a highly technique-sensitive surgical procedure.
Whilst there are numerous reviews which report the average incidence of complications in GBR, there is still insufficient evidence and manuscripts reporting a direct correlation between a specific biomaterial (membrane or scaffold) and observed complications. Only one recent systematic review and meta-analysis focused on wound healing complications following GBR for ridge augmentation procedures. Authors explored the complication rate based on the membrane type and on the timing of the first sign of soft tissue complications following bone augmentation procedures. They reported a complication rate of 17% of the overall soft tissue complications, including membrane exposure, soft tissue dehiscence, and acute infection (abscess). This estimate is consistent with that reported (12%) in a more recent systematic appraisal of the evidence on all types of complications in GBR (3). However, when horizontal augmentation procedures were reviewed, a higher rate (21%) of complications was reported within the first 18 months of a GBR procedure. This estimate was inclusive of all possible biologic complications following GBR whilst the rate of membrane exposure was of 23%.
Vertical bone augmentation represents one of the most challenging bone regenerative procedures in surgical dentistry. This is because of the inherent difficulties of the surgical procedure and the high risk of complications. The primary aim of this procedure is to recreate alveolar bone in a vertical direction (without the support of any pre-existing walls) and enable recreation of a more favourable anatomy for the restoration of the edentulous site.
Evidence on a variety of treatment options has been produced over the last 15 years including distraction osteogenesis, onlay bone grafting, and vertical ridge augmentation (VRA). Systematic reviews evaluating the efficacy of different surgical procedures for VRA either in a staged or a simultaneous fashion, reported a range of vertical bone gain of 2-8 mm. This gain was gradually lost (1.27 to 2.0mm) between 1 to 7 years post-surgery and a wide range of complications (0- 45.5%) has been reported.
The aim of this study is to assess and compare incidence of complications and percentage of vertical bone gain when using four different barrier membranes in combination with 50/50 autogenous and xenogenous bone material in VRA procedures. Secondary aims will be to evaluate and compare early and late soft tissue wound healing, gingival microvasculature and structure, patient reported outcomes and the prevalence of need for further bone augmentation and need for soft tissue grafting. Additionally, this study will also aim to assess and compare histomorphometry and histochemistry analyses of core biopsies obtained before implant placement between the four different barrier membranes.
Detailed description
This is a single centre non-inferiority adaptive randomised controlled clinical trial. The primary aim of this study will be:
To assess the clinical composite outcome (incidence of complications and percentage of vertical bone gain) of vertical alveolar bone grafting procedures in patients with vertical ridge deficiencies prior to dental implant placement, using a mix of autogenous and xenogenic particulate bone materials in combination with four different barrier membranes (Titanium (Ti)-Reinforced d-Polytetrafluoroethylene (PTFE) membrane [control group], Ti-Reinforced e-PTFE Membrane, 3D printed Ti-mesh and Reinforced PTFE Mesh (RPM)).
Secondary aims are:
- To assess and compare soft tissue wound healing and vascularization using Laser Doppler Flowmetry (LDF) between tests and control.
- To assess and compare gingival microvasculature and structure in vivo using Optical Coherence Tomography (OCT) between tests and control.
- To compare prevalence of the need for further bone grafting at the time of implant placement between tests and control.
- To compare prevalence of the need of soft tissue grafting at second stage surgery between tests and controls.
- To assess and compare patient reported outcomes using the EuroQol five-dimension (EQ-5D-5L) scale and the short-form Oral Health Impact Profile (OHIP-14) between tests and control.
- To assess and compare histomorphometry and histochemistry analyses of core biopsies obtained from a sample of 5 participants from each group before implant placement between tests and control.
Patients in need of vertical ridge augmentation prior to dental implant placement will be recruited to take part in this study and will be randomised into one of the following groups receiving different interventions:
- VRA using a 50/50 particulate bone mix (xenograft+ autograft) + Ti-Reinforced d- PTFE membrane (Positive Control)
- VRA using a 50/50 particulate bone mix (xenograft+ autograft) + Ti-Reinforced e-PTFE membrane (Test 1).
- VRA using a 50/50 particulate bone mix (xenograft+ autograft) + 3D printed Titanium mesh (Test 2).
- VRA using a 50/50 particulate bone mix (xenograft+ autograft) + Reinforced PTFE mesh (Test 3)
One-hundreds and forty-eight (148) participants meeting inclusion/exclusion criteria and who consent to this study will undergo a baseline visit assessment (visit 2) in which they will have a comprehensive oral assessment, radiographic assessment of alveolar defect using Cone Beam CT and supportive periodontal therapy. After randomisation to either Tests (1-3) or Control Groups, each group will undergo a VRA procedure as randomised (visit 3). All patients will be re-examined at 1, 3, 7, 15, 30, 60 and 120 days (visits 4-10, respectively) after the surgical augmentation. At each assessment, clinical examination, soft tissue imaging measures and saliva collections will be performed. Additionally, supportive periodontal therapy will be provided to all participants at the 120 days post augmentations visit. All participants will then undergo dental Implants placement after 180 days (visit 11). Participants will then be followed at 7, 15, 30,90, 120, 180 and 365 days (visits 12-18) after dental implant placement. The 90 days post implantation visit will include supportive periodontal therapy while the 120 days visit will involve the placement of dental implant prosthetic components for all participants.
Statistical methodology and analysis:
Primary and secondary outcomes analysis:
Continuous data are displayed as mean and standard deviation whilst categorical variables will be reported as percentages and prevalence. All participants randomized to test or control will be included in final analyses. Analysis will be performed using last observation carrying forward and as intent to treat population. Secondarily, per protocol analysis will also be performed. Data will be entered in an electronic spreadsheet and checked/proofed for any errors. All data will be loaded in the appropriate software for analysis. The primary outcome assessment will be assessed by analysis of co-variance model. Age, gender, body mass index and ethnicity will be included as principal covariates. Pair-wise comparison and between groups differences will be calculated using Tukey corrections.
All secondary endpoints will be analysed in a similar fashion. Significance will be set to be at p ≤ 0.05. Adverse events analysis will also be performed between study groups at study visits. Serial changes in imaging variables will be analysed with analysis of variance for repeated measures using a conservative F-test (Greenhouse-Geisser correction). If a treatment by time interaction will be found, pair-wise comparisons will be performed (Bonferroni-Holm adjustment).
Sensitivity and other planned analyses:
In this trial, investigators will perform some types of the sensitivity analysis, including non-statistical and statistical analyses. The sensitivity analysis that investigators will be including are impact of non-compliance/protocol deviation, impact of missing data, impact of competing risk in analysis of composites outcomes, impact of baseline imbalance, and finally, related to statistical analysis is impact of different assumptions underlying statistical model. The option plan for the condition related to non-compliance/protocol deviation are intention-to-treat (ITT) analysis; as per protocol analysis; and as-treated analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Positive Control | Active comparator | Procedure: VRA + d-PTFE membraneVRA using Ti-Reinforced d-PTFE membrane |
| Test 1 | Experimental | Procedure: VRA + e-PTFE membraneVRA using Ti-Reinforced e-PTFE membrane |
| Test 2 | Experimental | Procedure: VRA + customised Ti-meshVRA using 3D printed Titanium mesh |
| Test 3 | Experimental | Procedure: VRA + RPMVRA using Reinforced PTFE mesh |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Partially edentulous with a ridge that shows at least 3mm vertical bone deficiency;
- Females of childbearing potential and males agree to use an effective method of contraception from the time consent is signed until treatment discontinuation.
- Females of childbearing potential have a negative pregnancy test within 7 days prior to being registered. Participants are considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
- Willing and able to provide written informed consent.
Key exclusion criteria (8 listed)
- Comorbidities (or regular use of medications)
- History of bone augmentation or implant placement at the area of interest
- Females who are pregnant, planning pregnancy or breastfeeding
- Regular use of analgesic or antibiotics within 1 month before entering the study
- Disclosed smoking (including electronic cigarettes) or drinking over 14 alcoholic units per week
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 |
|---|---|---|
| VRA + d-PTFE membraneVRA using a 50/50 particulate bone mix (xenograft+ autograft) + Ti-Reinforced d-PTFE membrane | Procedure or surgery | Positive Control |
| VRA + e-PTFE membraneVRA using a 50/50 particulate bone mix (xenograft+ autograft) + Ti-Reinforced e-PTFE membrane | Procedure or surgery | Test 1 |
| VRA + customised Ti-meshVRA using a 50/50 particulate bone mix (xenograft+ autograft) + 3D printed Titanium mesh | Procedure or surgery | Test 2 |
| VRA + RPMVRA using a 50/50 particulate bone mix (xenograft+ autograft) + Reinforced PTFE mesh | Procedure or surgery | Test 3 |
Primary outcome
Incidence of complications
Time frame: Baseline visit (day 0) and follow up visits (at days 1, 4(±1), 7(±1), 15(±1), 30(±3), 60(±7) and 120(±7) post surgical VRA and at days 7(±1), 15(±1), 30(±7), 90(±7), 120(±7), 180 (±14) and 365 (±14) post dental implant placement
Measured by clinical observation/examination at each follow up visit following VRA surgery.
Percentage of vertical bone gain
Time frame: At baseline (before surgical VRA) and at time of dental implant(s) placement (not earlier than 180 days post surgical VRA)
Measured on cone beam computed tomography (CBCT).
8 secondary outcomes
Soft tissue vascularization and wound healing
Time frame: Baseline visit (day 0) and follow up visits (at days 1, 4(±1), 7(±1), 15(±1), 30(±3), 60(±7) and 120(±7) post surgical VRA and at days 7(±1), 15(±1), 30(±7), 90(±7), 120(±7), 180 (±14) and 365 (±14) post dental implant placement
Gingival microvasculature and structure in vivo
Time frame: Baseline visit (day 0) and follow up visits (at days 1, 4(±1), 7(±1), 15(±1), 30(±3), 60(±7) and 120(±7) post surgical VRA and at days 7(±1), 15(±1), 30(±7), 90(±7), 120(±7), 180 (±14) and 365 (±14) post dental implant placement
Need for additional bone grafting
Time frame: At time of dental implant(s) placement (not earlier than 180 days post surgical VRA)
Need of soft tissue grafting
Time frame: At time of dental implant(s) placement (not earlier than 180 days post surgical VRA)
Patient reported outcome measures
Time frame: Baseline visit (day 0) and follow up visits (at days 1, 4(±1), 7(±1), 15(±1), 30(±3), 60(±7) and 120(±7) post surgical VRA and at days 7(±1), 15(±1), 30(±7), 90(±7), 120(±7), 180 (±14) and 365 (±14) post dental implant placement
Patient reported outcome measures
Time frame: Baseline visit (day 0) and follow up visits (at days 1, 4(±1), 7(±1), 15(±1), 30(±3), 60(±7) and 120(±7) post surgical VRA and at days 7(±1), 15(±1), 30(±7), 90(±7), 120(±7), 180 (±14) and 365 (±14) post dental implant placement
Histomorphometry analysis
Time frame: At time of dental implant(s) placement (not earlier than 180 days post surgical VRA)
Histochemistry analysis
Time frame: At time of dental implant(s) placement (not earlier than 180 days post surgical VRA)
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 5 Feb 2024.
- Results publication: PubMed 37495541Alotaibi FF, Rocchietta I, Buti J, D'Aiuto F. Comparative evidence of different surgical techniques for the management of vertical alveolar ridge defects in terms of complications and efficacy: A systematic review and network meta-analysis. J Clin Periodontol. 2023 Nov;50(11):1487-1519. doi: 10.1111/jcpe.13850. Epub 2023 Jul 26.
- Results publication: PubMed 25622713Rocchietta I, Simion M, Hoffmann M, Trisciuoglio D, Benigni M, Dahlin C. Vertical Bone Augmentation with an Autogenous Block or Particles in Combination with Guided Bone Regeneration: A Clinical and Histological Preliminary Study in Humans. Clin Implant Dent Relat Res. 2016 Feb;18(1):19-29. doi: 10.1111/cid.12267. Epub 2015 Jan 27.
- Individual participant dataSharing planned: No. Could be available upon reasonable request
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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.
Francesco D'Aiuto principal investigator
University College, London
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VRA + d-PTFE membrane, VRA + e-PTFE membrane and VRA + customised Ti-mesh in people with Alveolar Bone Resorption and Alveolar Ridge Trauma, run by University College, London.
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 4 inclusion and 8 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 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Francesco D'Aiuto, PhD (+442034561108, f.daiuto@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of complications (time frame: Baseline visit (day 0) and follow up visits (at days 1, 4(±1), 7(±1), 15(±1), 30(±3), 60(±7) and 120(±7) post surgical VRA and at days 7(±1), 15(±1), 30(±7), 90(±7), 120(±7), 180 (±14) and 365 (±14) post dental implant placement). 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 NCT06242782, 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 5 Feb 2024.