Vertical Ridge Augmentation Strategies

NCT06242782 | Not Yet Recruiting Phase 3 DMC FDA Device

• 2 other identifiers: IRAS ID 297914EDGE ID 144889
• Study Type: interventional
• Target: 148
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Alveolar Bone Resorption; Alveolar Ridge Trauma; Alveolar Bone Loss; Complication of Surgical Procedure

Keywords

Vertical Ridge Augmentation; Vertical Bone Augmentation; Alveolar Bone Grafting

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (8)

• Soft tissue vascularization and wound healing

  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

  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

  At time of dental implant(s) placement (not earlier than 180 days post surgical VRA)

• Need of soft tissue grafting

  At time of dental implant(s) placement (not earlier than 180 days post surgical VRA)

• Patient reported outcome measures

  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

Study Arms (4)

Positive Control

ACTIVE COMPARATOR

VRA using Ti-Reinforced d-PTFE membrane

Procedure: VRA + d-PTFE membrane

Test 1

EXPERIMENTAL

VRA using Ti-Reinforced e-PTFE membrane

Procedure: VRA + e-PTFE membrane

Test 2

EXPERIMENTAL

VRA using 3D printed Titanium mesh

Procedure: VRA + customised Ti-mesh

Test 3

EXPERIMENTAL

VRA using Reinforced PTFE mesh

Procedure: VRA + RPM

Interventions

VRA + d-PTFE membrane PROCEDURE

VRA using a 50/50 particulate bone mix (xenograft+ autograft) + Ti-Reinforced d-PTFE membrane

Positive Control

VRA + e-PTFE membrane PROCEDURE

VRA using a 50/50 particulate bone mix (xenograft+ autograft) + Ti-Reinforced e-PTFE membrane

Test 1

VRA + customised Ti-mesh PROCEDURE

VRA using a 50/50 particulate bone mix (xenograft+ autograft) + 3D printed Titanium mesh

Test 2

VRA + RPM PROCEDURE

VRA using a 50/50 particulate bone mix (xenograft+ autograft) + Reinforced PTFE mesh

Test 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead

Related Publications (2)

• 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.

  PMID: 37495541 RESULT

• 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 Dent Relat Res. 2016 Feb;18(1):19-29. doi: 10.1111/cid.12267. Epub 2015 Jan 27.

  PMID: 25622713 RESULT

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Francesco D'Aiuto

  University College, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco D'Aiuto, PhD

CONTACT

+442034561108; f.daiuto@ucl.ac.uk

Faisal Alotaibi

CONTACT

+966560007667; faisal.alotaibi.20@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: February 5, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): February 1, 2030
• Last Updated: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share