Computer Guided Versus Conventional Augmentation Using Bone Ring

February 8, 2017 updated by: Mohamed Ahmed Younis, Cairo University

Evaluation of Computer-Guided Versus Conventional Simultaneous Implant Placement With Ridge Augmentation Using an Autogenous Bone Ring Graft With PRF on Patient's Esthetic Satisfaction

Using bone ring grafts with simultaneous implant placement after three-dimensional augmentation of severely defective bone ridges using computer-guided surgical templates. The study compares accuracy effectiveness by mimics software

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To study the effectiveness of computer guided surgical stents in ridge augmentation with implant insertion compared with free hand augmentation

-Population/Intervention/Comparator/Outcome (PICO)-

Population (P): patients with massive bone resorption horizontally and vertically, severe bone loss around teeth, periodontal disease or traumatic extraction in partially edentulous maxillary anterior region requiring implant insertion.

Intervention (I): simultaneous implant placement with ridge augmentation using computer guided surgical templates with PRF.

Comparator (C): Free hand simultaneous implant placement with ridge augmentation.

Outcome (O): Patient esthetic satisfaction - Augmentation and implant insertion accuracy

Study Type

Interventional

Enrollment (Anticipated)

10

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 Locations

  • Egypt
    • Cairo
      • Giza, Cairo, Egypt
        • Cairo University
        • Contact:
          • mohamed A Younis, Dentist

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

21 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with insufficient alveolar ridge or severe alveolar bone resorption horizontally and vertically in partially edentulous maxillary anterior region.
  2. Medically free patients in order to be a confounding factor on the final results.
  3. Highly motivated patients.
  4. Good oral hygiene.
  5. Patients physically able to tolerate surgical and restorative procedures.

Exclusion Criteria:

  1. Young patients (incomplete bone growth).
  2. Patients with any systemic disease that could affect bone healing.
  3. Patients allergic to local anaesthetic agent.
  4. Pregnant or lactating females.
  5. Presence of any pathosis in the area.
  6. history of oral radiotherapy.
  7. history of prolonged steroid use.
  8. Psychological disorders.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Computer Guided Stent Augmentation
Patients with defective maxillary anterior alveolar ridges requiring implant insertion will have simultaneous implant placement with ridge augmentation using autogenous bone ring graft covering them with Platelet-rich fibrin (PRF) using computer guided stent.
Procedure: Computer Guided Stent Augmentation
Defective alveolar ridge is to be replaced by simultaneous implant placement with ring graft augmentation (Trephine Drill to obtain the ring graft autogenous bone) using computer guided stent and covered with Platelet-rich fibrin (PRF), by using venous blood from the patient, a centrifuge will be used to obtain the top layer after centrifuging blood at 3000 Revolution Per Minute (RPM) for 10 minutes.
Other Names:
  • Autograft
  • Computer Guided Surgery
Drug: Platelet-rich fibrin (PRF)
Device: implant
Active Comparator: Free Hand Augmentation
Patients with defective maxillary anterior alveolar ridges requiring implant insertion will have simultaneous implant placement with ridge augmentation using Free hand simultaneous implant placement with ridge augmentation and covering them with Platelet-rich fibrin (PRF).
Drug: Platelet-rich fibrin (PRF)
Device: implant
Procedure: Free Hand Augmentation
Defective alveolar ridge is to be replaced by Free Hand simultaneous implant placement with ring graft augmentation (Trephine Drill to obtain the ring graft autogenous bone) and covered with Platelet-rich fibrin (PRF), by using venous blood from the patient, a centrifuge will be used to obtain the top layer after centrifuging blood at 3000 RPM for 10 minutes.
Other Names:
  • Autograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction regarding esthetic results.
Time Frame: 5 month
outcome will be measured using questionnaire
5 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of computer guided surgical templates in comparison with 3D virtual planning.
Time Frame: immediately after procedure
Comparing the results on the patient with the design made by the surgical software.
immediately after procedure

Collaborators and Investigators

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

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

February 1, 2017

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

February 6, 2017

First Submitted That Met QC Criteria

February 8, 2017

First Posted (Estimate)

February 9, 2017

Study Record Updates

Last Update Posted (Estimate)

February 9, 2017

Last Update Submitted That Met QC Criteria

February 8, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CairoBRG-PRF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Evaluation of The Comparative Effectiveness of Computer Guided Surgical stents in Anterior Ridge Defects with Bone Ring Graft and PRF

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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