Bone Augmentation Techniques in the Mandible Posterior Region

NCT ID: NCT06661447

Last Updated: 2024-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2029-12-15

Brief Summary

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This study aims to compare the efficacy of two bone augmentation techniques in the posterior mandible. Twenty participants will undergo 40 surgical procedures at Espíritu Santo University (UEES) in Samborondon, Ecuador. Each patient will receive two types of bone grafts: one side will use autogenous cortical bone plates with a 50/50 mixture of autogenous bone and biomaterial (as described by Dr. Fouad Khoury), while the other side will use xenogenous cortical bone plates with the same mixture.

Detailed Description

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Conditions

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Bone Substitutes Alveolar Bone Grafting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Split mouth randomized clinical trial will performed in 40 patient with bilateral edentulous atrophic posterior region.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
The participants will not know which technique is being used in their edentulous area.

The investigator will not be informed which grafting technique was performed in the edentulous areas.

The outcomes assessor will not be informed of which procedures were performed on the participants.

Study Groups

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Autogenous Onlay bone graft

All patients will be submitted under a Onlay bone graft Technique with autogenous block bones is perform in one of the two Bilateral Mandibular Posterior Edentulous areas. The inner space is filled with a mixture of autogenous and xenogeneic particulated bone

Group Type ACTIVE_COMPARATOR

Tridimensional Onlay autologous bone graft

Intervention Type PROCEDURE

A thick block from the ramus area of the mandible are cut longitudinally with a microsaw into two thin pieces with the same surface area. The two thin block are used to rebuild the two wall of the future alveolar crest and stabilized with osteosynthesis screw of the edentulous area. The remaining space is filled with a mixture of autogenic and xenogeneic particulate bone.

Xenogeneic Onlay bone graft

In 20 patients, A xenogeneic onlay bone graft is positioned in the remaining mandibular posterior edentulous area. The inner space is filled with a mixture of autogenous and xenogeneic particulated bone

Group Type EXPERIMENTAL

Tridimensional Onlay xenogeneic bone graft

Intervention Type PROCEDURE

A tridimensional Onlay xenogeneic bone graft is positioned and stabilized with osteosynthesis screw of the edentulous area. The remaining space is filled with a mixture of autogenic and xenogeneic particulate bone.

Allogenic Onlay bone graft

In 20 patients, A allogenic onlay bone graft is positioned in the remaining mandibular posterior edentulous area. The inner space is filled with a mixture of autogenous and xenogeneic particulated bone

Group Type EXPERIMENTAL

Tridimensional Onlay allogenic bone graft

Intervention Type PROCEDURE

A tridimensional Onlay allogenic bone graft is positioned and stabilized with osteosynthesis screw of the edentulous area. The remaining space is filled with a mixture of autogenic and xenogeneic particulate bone.

Interventions

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Tridimensional Onlay autologous bone graft

A thick block from the ramus area of the mandible are cut longitudinally with a microsaw into two thin pieces with the same surface area. The two thin block are used to rebuild the two wall of the future alveolar crest and stabilized with osteosynthesis screw of the edentulous area. The remaining space is filled with a mixture of autogenic and xenogeneic particulate bone.

Intervention Type PROCEDURE

Tridimensional Onlay xenogeneic bone graft

A tridimensional Onlay xenogeneic bone graft is positioned and stabilized with osteosynthesis screw of the edentulous area. The remaining space is filled with a mixture of autogenic and xenogeneic particulate bone.

Intervention Type PROCEDURE

Tridimensional Onlay allogenic bone graft

A tridimensional Onlay allogenic bone graft is positioned and stabilized with osteosynthesis screw of the edentulous area. The remaining space is filled with a mixture of autogenic and xenogeneic particulate bone.

Intervention Type PROCEDURE

Other Intervention Names

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Shell technique 3D Onlay bone graft Khoury´s bone graft technique

Eligibility Criteria

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Inclusion Criteria

* Patients with Bilateral Mandibular Posterior Edentulous with atrophy in 4, 5 or 6 Cawood and Howell stages.
* Patients who have good plaque control of less than 20%
* Patients between 18-64 years old

Exclusion Criteria

* Systemically compromised patients
* Smoker patients
* Pregnant women, breastfeeding or use of oral contraceptives
* Patients who are taking medication that may affect healing and coagulation
* Patients with periodontal disease
* Patients who have undergone chemotherapy and radiotherapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Especialidades Espiritu Santo

OTHER

Sponsor Role lead

Responsible Party

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Antonio Lanata Flores

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Antonio G Lanata-Flores

Role: CONTACT

+593983820084

References

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Khoury F, Hanser T. Three-Dimensional Vertical Alveolar Ridge Augmentation in the Posterior Maxilla: A 10-year Clinical Study. Int J Oral Maxillofac Implants. 2019 Mar/Apr;34(2):471-480. doi: 10.11607/jomi.6869.

Reference Type BACKGROUND
PMID: 30883623 (View on PubMed)

Other Identifiers

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2024-ODONT-002

Identifier Type: -

Identifier Source: org_study_id

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