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NCT Number: NCT06420713

Horizontal Bone Augmentation of Alveolar Ridge

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.

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Key information

Conditions

Platelet-rich Fibrin Atrophic Maxilla Bone Diseases Bone Regeneration Bone Resorption Bone Substitutes Cone-Beam Computed Tomography Jaw Diseases Maxillary Diseases Musculoskeletal Diseases Stomatognathic Diseases

Age range

21 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dentistry of Ribeirão Preto - USP

Ribeirão Preto, São Paulo, 14040-904, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

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.

Treatment and study plan

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

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.

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.

Primary outcomes

  1. Micro-CT and Histometric analyses

    Time frame: 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 outcomes

  1. Dental Implants ISQ measurement

    Time frame: 6 months

    ISQ will be measured at the moment of implant placement and after 6 months.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Use of Xenogeneic Bone Graft Associated With Autogenous Bone Graft or Leukocyte-and-Platelet-Rich Fibrin (L-PRF) for Horizontal Bone Augmentation of Alveolar Ridge: A Randomized Controlled Clinical Trial

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
May 20, 2024
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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