## Protocol Section
### Identification Module
**NCT ID:** NCT06420713

**Brief Title:** Horizontal Bone Augmentation of Alveolar Ridge: A Randomized Controlled Clinical Trial.

**Official 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

#### Organization Study ID Info
**ID:** 13102219.0.0000.5419
#### Organization
**Class:** OTHER
**Full Name:** University of Sao Paulo
### Status Module
#### Completion Date
**Date:** 2024-05-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-04-30

**Type:** ACTUAL

#### Start Date
**Date:** 2019-10-20

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Sao Paulo

#### Responsible Party

**Investigator Affiliation:** University of Sao Paulo

**Investigator Full Name:** Michel Reis Messora

**Investigator 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

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Platelet-rich Fibrin

- Bone Substitutes

- Atrophic Maxilla

- Cone-beam Computed Tomography

- Bone Regeneration

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 28

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Procedure: Groups

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

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Procedure: Horizontal Bone Augmentation of Alveolar Ridge

**Label:** Groups

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Intervention Names:**

- Procedure: Dental Implants

**Label:** Dental Implants

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Groups

**Description:** 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.

**Name:** Horizontal Bone Augmentation of Alveolar Ridge

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

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

**Description:** 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.

**Name:** Groups

**Type:** PROCEDURE

#### Intervention 3

**Arm Group Labels:**

- Dental Implants

**Description:** 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.

**Name:** Dental Implants

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Micro-CT and Histometric analyses

**Time Frame:** 8 months

#### Secondary Outcomes

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

**Measure:** Dental Implants ISQ measurement

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 74 Years

**Minimum Age:** 21 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ribeirão Preto

**Country:** Brazil

**Facility:** School of Dentistry of Ribeirão Preto - USP

**State:** São Paulo

**Zip:** 14040-904

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020763

- Term: Pathological Conditions, Anatomical

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4589

- Name: Atrophy

- Relevance: HIGH

- As Found: Atrophic

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001284

- Term: Atrophy

### Misc Info Module

- Version Holder: 2024-05-31
