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

Bone Loss, Alveolar Clinical Trial

Official title:

Evaluation Of Vertical Bone Gain Following One Stage Ridge Augmentation With Advanced Platelet Rich Fibrin (A-PRF) And Xenograft Compared to Guided Bone Regeneration Using Collagen Membrane and Xenograft.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03855852
• Other study ID #: CEBD-CU-2019-02-15
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: May 2019
• Source: Cairo University
• Contact: Abdallah W Shabir, B.D.S
• Phone: 01281855966
• Email: abdallah.w.shbair[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Bone Loss, Alveolar

Intervention

Procedure:
• Xenograft and Collagen membrane
Placing the implant with collagen membrane and xenograft at esthetic zone of maxillary ridge with 2-4 mm thread exposure .
• Xenograft and APRF
Placing the implant with APRF and xenograft at esthetic zone of maxillary ridge with 2-4 mm thread exposure .

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry , Cairo University	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vertical buccal bone gain	It will be measured using UNC Periodontal probe	6 months
Secondary	horizontal bone gain	It will be measured using UNC Periodontal probe	6 months
Secondary	Ridge width	It will be measured using bone caliper	6 months
Secondary	Post-surgical patient satisfaction	It will be measured using Questionnaire	9 months