Evaluation of Vertical Bone Gain After Ridge Augmentation With APRF & Xenograft Vs Collagen Membrane & Xenograft. RCT

Cairo University (CU)

Status: Unknown

Conditions: Bone Loss, Alveolar

Treatments: Procedure: Xenograft and Collagen membrane; Procedure: Xenograft and APRF

Study type: Interventional

Funder types: Other

Identifiers

NCT03855852

CEBD-CU-2019-02-15

Details and patient eligibility

About

Comparative study for evaluation of vertical bone gain after one stage ridge augmentation with advanced platelet rich fibrin (A-PRF) and xenograft versus guided bone regeneration using collagen membrane and xenograft.

Full description

Summry description

• Dental implants represent a reliable mean for replacing missing teeth and restoring dental function.
• With increased use of dental implants in replacement of missing teeth in partially edentulous patients the need for implants that satisfy both esthetics and function .
• Thus, the concept of restoration-driven implant placement has been introduced to provide a good match between the position of implant and the future position of the implant supported-restoration to provide a good clinical outcome.
• The concept of prosthetic-driven implant dimensional changes are expected in the hard and soft tissues.
• About 50% of alveolar bone loss occurs in the buccolingual direction in the first 12 months after tooth extraction.
• The alveolar process can be too narrow to facilitate a complete bony surrounding of the placed dental implant.
• Which may lead to a peri-implant bony dehiscence when placing an implant.
• One stage ridge augmentation procedure has been advocated in management of buccal dehiscence and fenestration defects that may develop with implant placement according to prosthetic-driven implant placement concept.
• Guided bone regeneration techniques (GBR) are commonly used in management of these defects.
• However, controversy still exists concerning the complications that may arise such as membrane exposure and its effects on bone regeneration and the possibility of using bone grafts alone to overcome these problems.
• This research promotes the evaluation of A-PRF in combination with xenograft in one stage ridge augmentation.
• The addition of A-PRF to bone grafts has been reported to enhance the process of bone regeneration through different mechanisms.
• Ridge augmentation according to the principle of GBR using collagen membrane and bone graft has been proven to be predictable in producing significant bone gain promoting implant placement.
• The aim of the study is to clinically evaluate vertical bone gain in buccal peri-implant dehiscence and fenestration defects following application of advanced PRF plus xenograft compared to guided bone regeneration using collagen membrane and xenograft.

Surgical procedure:

• Control group: (Implant placement with xenograft and collagen membrane) After Para crestal incision and raising the mucoperiosteal flap at the top of the alveolar process, the exact position of the dental implant will be defined as determined by preoperative measurements, dental setup, and surgical guide. Bone level implants will be placed 3 mm apical to the expected cervical border of the crown.

The titanium surface of the dental implant will be covered with bone graft (xenograft), and coverage with a resorbable collagen membrane.

-Test group: (implant placement with xenograft and A-PRF) The alveolar bone exposure and implant osteotomy will be prepared and inserted in same manner as in the control group. The titanium surface of the dental implant will be covered with A-PRF and xenograft.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 18 years old.
• Systemically healthy.
• Has good dental health.
• Missing a single tooth in the maxillary anterior and premolar region
• Crestal residual ridge width of 4-5mm.
• Residual ridge with an adequate band of keratinized tissue (2 mm).
• Residual ridge with sufficient vertical bone height to safely place a >10 mm long dental implant.

Exclusion criteria

• Severe parafunctional habits, for example, bruxing and clenching.
• Conditions that complicate wound healing, for example, uncontrolled diabetes (defined as HBA1c level >7%) or smoking.
• Conditions that might lead to a possibly lowered regenerative capacity of the bone, for example, osteoporosis and Paget's disease.
• Pregnant or expecting to be pregnant.
• History of drug and alcohol abuse or certain medications like bisphosphonates or steroids currently or within the past three months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Xenograft and Collagen membrane

Active Comparator group

Description:

Placing the implant with collagen membrane and xenograft at esthetic zone of maxillary ridge when 2-4 mm of implant threads exposure .

Treatment:

Procedure: Xenograft and Collagen membrane

Xenograft and A-PRF

Experimental group

Description:

Placing the implant with xenograft and A-PRF at esthetic zone of maxillary ridge when 2-4 mm of implant threads exposure .

Treatment:

Procedure: Xenograft and APRF