Alveolar Bone Loss Clinical Trial
— VARGASOfficial 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%. 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.
Status | Not yet recruiting |
Enrollment | 148 |
Est. completion date | February 2030 |
Est. primary completion date | August 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Partially edentulous with a ridge that shows at least 3mm vertical bone deficiency; 2. Females of childbearing potential and males agree to use an effective method of contraception from the time consent is signed until treatment discontinuation. 3. 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. 4. Willing and able to provide written informed consent. Exclusion Criteria: 1. Comorbidities (or regular use of medications) 2. History of bone augmentation or implant placement at the area of interest 3. Females who are pregnant, planning pregnancy or breastfeeding 4. Regular use of analgesic or antibiotics within 1 month before entering the study 5. Disclosed smoking (including electronic cigarettes) or drinking over 14 alcoholic units per week 6. Active oral diseases or poor oral hygiene (defined by full mouth dental plaque scores greater than 25%) 7. Suspected or documented titanium allergy or intolerance 8. Concurrent and/or recent involvement in other research that is likely to interfere with the intervention within last 3 months of study enrolment |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University College, London |
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 Periodo — View Citation
Rocchietta 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 D — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of complications | Measured by clinical observation/examination at each follow up visit following VRA surgery. | 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 | |
Primary | Percentage of vertical bone gain | Measured on cone beam computed tomography (CBCT). | At baseline (before surgical VRA) and at time of dental implant(s) placement (not earlier than 180 days post surgical VRA) | |
Secondary | Soft tissue vascularization and wound healing | Measured by Laser Doppler Flowmetry (LDF). | 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 | |
Secondary | Gingival microvasculature and structure in vivo | Measured by Optical Coherence Tomography (OCT) | 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 | |
Secondary | Need for additional bone grafting | At time of dental implant(s) placement (not earlier than 180 days post surgical VRA) | ||
Secondary | Need of soft tissue grafting | At time of dental implant(s) placement (not earlier than 180 days post surgical VRA) | ||
Secondary | 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. | 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 | |
Secondary | 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. | 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 | |
Secondary | Histomorphometry analysis | Using core biopsies obtained from a sample of 5 participants from each group | At time of dental implant(s) placement (not earlier than 180 days post surgical VRA) | |
Secondary | Histochemistry analysis | Using core biopsies obtained from a sample of 5 participants from each group | At time of dental implant(s) placement (not earlier than 180 days post surgical VRA) |
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