Horizontal Bone Augmentation of Alveolar Ridge

Not Applicable

Completed

• Conditions: Bone Substitutes; Atrophic Maxilla; Cone-beam Computed Tomography; Platelet-rich Fibrin; Bone Regeneration
• Interventions: Procedure: Horizontal Bone Augmentation of Alveolar Ridge; Procedure: Groups; Procedure: Dental Implants

• Registration Number: NCT06420713
• Lead Sponsor: University of Sao Paulo

Brief Summary

The objective of this randomized controlled clinical trial was to evaluate the effects of particulate xenogeneic bone grafts associated with autogenous bone graft or Leukocyte-and-Platelet-Rich Fibrin (L-PRF) for horizontal alveolar ridge augmentation. Twenty-eight patients presenting edentulous regions and requiring horizontal bone augmentation prior to dental implant placement were included in this study and randomly divided into two groups according to the proposed guided bone regeneration (GBR) treatment.

Fourteen surgical sites corresponding to Group A received bone regeneration with particulate autogenous bone tissue associated with deproteinized bovine bone graft (Bio-Oss Small®; Geistlich AG, Wolhusen, Switzerland). In Group B, fourteen surgical sites were regenerated with deproteinized bovine bone graft (Bio-Oss Small®) associated with L-PRF. In both groups, the grafted region was protected by a collagen membrane (Bio-Gide® Compressed; Geistlich AG, Wolhusen, Switzerland) fixed to the buccal and palatal bone plates using titanium pins.

Cone-beam computed tomography (CBCT) scans were performed preoperatively, immediately after the GBR surgical procedure, after 8 months of GBR healing, and immediately after dental implant placement to measure linear and volumetric changes in the alveolar ridge. At the time of dental implant placement, after an average period of 8 months following the guided bone regeneration procedures, bone biopsies were taken from the grafted area for histological, histomorphometric, and micro-CT analysis.

After a period of 6 months, the dental implants were reopened to receive implant-supported prosthetic rehabilitation. Implant stability was assessed using resonance frequency analysis at the time of implant placement in the grafted area and after an average of 6 months during the reopening surgical stage. Patient pain perception following bone regeneration procedures was assessed using a visual analog scale. All obtained data were statistically analyzed.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-20
• Primary Completion: 2024-04-30
• Study Completion: 2024-05-09
• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-17
• Study First Posted: 2024-05-20
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-09
• Last Update Posted: 2024-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• a requirement for the placement of one to four dental implants exclusively in the maxilla;
• insufficient horizontal bone remaining for dental implant placement (maximum width of 4mm);
• sufficient vertical bone height for subsequent placement of dental implant(s).

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Exclusion Criteria

• any contraindication for dental implant placement;
• the need for vertical bone augmentation;
• inflammatory or autoimmune disease in the oral cavity;
• use of immunosuppressants, corticosteroids, or bisphosphonates;
• a history of malignancy in the past 5 years;
• smokers;
• patients reporting excessive alcohol consumption;
• decompensated systemic condition;
• uncontrolled periodontal disease;
• insulin-dependent diabetic patients;
• patients with blood-related diseases.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Groups	Horizontal Bone Augmentation of Alveolar Ridge	-
Autogenous bone graft or Leukocyte-and-Platelet-Rich Fibrin (L-PRF)	Groups	-
Dental Implants	Dental Implants	-

Primary Outcome Measures

Name	Time	Method
Micro-CT and Histometric analyses	8 months	After the period of 8 months from Horizontal Bone Augmentation of Alveolar Ridge, during the dental implant placement by guided surgery, bone samples will be collected at the same location of the implants preparation. The collected bone tissue will be prepared and submitted to Micro-CT and histometric analyses.

Secondary Outcome Measures

Name	Time	Method
Dental Implants ISQ measurement	6 months	ISQ will be measured at the moment of implant placement and after 6 months.

Trial Locations

Locations (1)

School of Dentistry of Ribeirão Preto - USP; 🇧🇷 Ribeirão Preto, São Paulo, Brazil