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

May 15, 2019 updated by: Abdallah waleed sobhi Shbair, Cairo University

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Giza, Egypt, 12613
        • Recruiting
        • Faculty of dentistry , Cairo university
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Xenograft and Collagen membrane
Placing the implant with collagen membrane and xenograft at esthetic zone of maxillary ridge when 2-4 mm of implant threads exposure .
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 .
Experimental: Xenograft and A-PRF
Placing the implant with xenograft and A-PRF at esthetic zone of maxillary ridge when 2-4 mm of implant threads exposure .
Procedure: Xenograft and APRF
Placing the implant with APRF and xenograft at esthetic zone of maxillary ridge with 2-4 mm thread exposure .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vertical buccal bone gain
Time Frame: 6 months
It will be measured using UNC Periodontal probe
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
horizontal bone gain
Time Frame: 6 months
It will be measured using UNC Periodontal probe
6 months
Ridge width
Time Frame: 6 months
It will be measured using bone caliper
6 months
Post-surgical patient satisfaction
Time Frame: 9 months
It will be measured using Questionnaire
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Abdallah M Shbair, B.D.S, Dr

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Anticipated)

March 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

February 25, 2019

First Submitted That Met QC Criteria

February 25, 2019

First Posted (Actual)

February 27, 2019

Study Record Updates

Last Update Posted (Actual)

May 16, 2019

Last Update Submitted That Met QC Criteria

May 15, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBD-CU-2019-02-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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