Horizontal Bone Augmentation of Alveolar Ridge

NCT06420713 | Completed DMC

• 1 other identifier: 13102219.0.0000.5419
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Platelet-rich Fibrin; Bone Substitutes; Atrophic Maxilla; Cone-beam Computed Tomography; Bone Regeneration

Outcome Measures

Primary Outcomes (1)

• Micro-CT and Histometric analyses

  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.

  8 months

Secondary Outcomes (1)

• Dental Implants ISQ measurement

  6 months

Study Arms (3)

Autogenous bone graft or Leukocyte-and-Platelet-Rich Fibrin (L-PRF)

ACTIVE COMPARATOR

Procedure: Groups

Groups

ACTIVE COMPARATOR

Procedure: Horizontal Bone Augmentation of Alveolar Ridge

Dental Implants

ACTIVE COMPARATOR

Procedure: Dental Implants

Interventions

Horizontal Bone Augmentation of Alveolar Ridge PROCEDURE

Elevation of the flap in the anterior region of atrophic maxilla to receive particulate autogenous bone mixed with deproteinized bovine bone graft (Group A) or Leukocyte-and-Platelet-Rich Fibrin (L-PRF) mixed with deproteinized bovine bone graft (Group B). In both groups, bone augmentations were covered with a collagen membrane stabilized with pins.

Groups

Groups PROCEDURE

The patients underwent Guided Bone Regeneration (GBR) procedures for the reconstruction of atrophic edentulous alveolar ridges and were divided into two groups according to the proposed treatment: Group A - GBR using a mixture of particulate autogenous bone graft and deproteinized bovine bone graft (Bio-Oss® Small; Geistlich AG, Wolhusen, Switzerland). Group B - GBR using a mixture of deproteinized bovine bone graft (Bio-Oss® Small) and L-PRF + Liquid Fibrinogen.

Autogenous bone graft or Leukocyte-and-Platelet-Rich Fibrin (L-PRF)

Dental Implants PROCEDURE

After 8 months of GBR healing, dental implants were placed in the grafted regions using guided surgery techniques. Cone beam computed tomography (CBCT) scans were performed preoperatively, immediately after the surgical procedure, and after 8 months of follow-up to measure the linear and volumetric changes in the alveolar ridge. At the time of dental implant placement, after an 8-month period following the GBR procedures, bone biopsies were obtained from the grafted area for histological and micro-CT analysis. The stability of the implants was assessed using resonance frequency analysis in the immediate postoperative period and at 6 months postoperatively. After the 6-month period following dental implant placement, the patients were cleared for implant-supported prosthetic rehabilitation.

Dental Implants

Eligibility Criteria

• Age: 21 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

School of Dentistry of Ribeirão Preto - USP

Ribeirão Preto, São Paulo, 14040-904, Brazil

Location

MeSH Terms

Conditions

Atrophic Maxilla

Interventions

Population Groups; Dental Implants

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Maxillary Diseases; Jaw Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor at the department of Oral and Maxillofacial Surgery and Periodontology, School of Dentistry of Ribeirao Preto, University of Sao Paulo-USP, Ribeirao Preto, São Paulo, Brazil

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 20, 2024
• Study Start: October 20, 2019
• Primary Completion: April 30, 2024
• Study Completion: May 9, 2024
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)