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Computer Guided Simultaneous Implant Placement With Tri-cortical Ridge Augmentation Using Chin Cortical Bone Struts in Anterior Atrophic Maxilla: A Case Series

Primary Purpose

Ridge Augmentation

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Computer guided simultaneous implant placement with tri-cortical ridge augmentation using chin cortical bone struts
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ridge Augmentation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with single or Multiple missing Maxillary Anterior Teeth with vertically and horizontally defective ridges having adequate soft tissue ample. Patients who gave their consent for this trial. Males and females will be included. Exclusion Criteria: Patients on bisphosphonates or drugs altering bone metabolism, within 2 months before initiating the study. Subjected to irradiation in the head and neck area less than 1 year before implantation. Patients allergic to drugs used in the study. Patients having a history of a major medical condition (ASA 3,4) Untreated periodontitis. Poor oral hygiene and motivation. Uncontrolled diabetes. Pregnant or nursing. Substance abuse. Psychiatric problems or unrealistic expectations. Severe bruxism or clenching. Immunosuppressed or immunocompromised patients. Treated or under treatment with intravenous amino-bisphosphonates. Active infection or severe inflammation in the area intended for implant placement. Unable to open mouth sufficiently to accommodate the surgical tooling. Patients participating in other studies, if the present protocol could not be properly followed. Referred only for implant placement or unable to attend a 5-year follow-up.

Sites / Locations

  • Faculty of Dentistry, Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ridge augmentation surgery

Arm Description

Computer guided simultaneous implant placement with tri-cortical ridge augmentation using chin cortical bone struts in anterior atrophic maxilla

Outcomes

Primary Outcome Measures

Bone quality (change in bone density)
Serial CBCT scans measuring change in bone density in grey value

Secondary Outcome Measures

Bone quantity (bone formation "height and width")
Serial CBCT scans (T0 before surgery, T1 immediately after surgery, T2 after 6 month) measuring bone quantity in mm
Implant stability
measure primary stability immediately after implant placement and in the second surgery using Osstell device (ISQ value of 1-100)
Accuracy of Plan Transfer
Superimposition of preoperative digital plan and the immediate postoperative CBCT to assess the positional discrepancy of the graft between the digitally plan versus the actual postoperative position will be measured in millimeters three dimensionally (anteroposterior, vertical and lateral position).

Full Information

First Posted
November 14, 2022
Last Updated
September 4, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05731063
Brief Title
Computer Guided Simultaneous Implant Placement With Tri-cortical Ridge Augmentation Using Chin Cortical Bone Struts in Anterior Atrophic Maxilla: A Case Series
Official Title
Computer Guided Simultaneous Implant Placement With Tri-cortical Ridge Augmentation Using Chin Cortical Bone Struts in Anterior Atrophic Maxilla: A Case Series
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 27, 2023 (Actual)
Primary Completion Date
February 27, 2024 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
10 patients having deficient anterior maxilla will be recruited and a preoperative CBCT will be done to evaluate the vertical and horizontal dimensions of the intended alveolar ridge. pre-operative manufacturing of the digital surgical guides performed for Harvesting of the chin cortical bone struts from the symphysial area in the donor site and for Placement of the grafted cortical bone struts and the implant in the recipient site. Intra operatively the donor site (Chin) will be prepared to harvest autogenous bone from the chin aided by the patient's prefabricated bone harvesting guide. The recipient site (Maxillary anterior defect) will be prepared to receive the chin grafts. Grafts will be screwed in position and implants will be screwed in its preparation until it gains primary stability from basal bone, using the prefabricated bone fixation-implant placement guide. Any gaps will be filled with autogenous bone particulates from the chin. A healing tie base Abutment will be screwed into the implant through the third cortex. Primary stability will be assessed using Osstell device. An immediate postoperative CBCT will be done and superimposed on the preoperative CBCT to measure accuracy of plan transfer to make sure the planning was followed accurately. Follow up after 6 months and CBCT will be done for bone formation and density assessment and implant exposure for implant stability measurement-using osstell and removal Healing abutment and consecutive prosthetic loading.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ridge Augmentation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ridge augmentation surgery
Arm Type
Other
Arm Description
Computer guided simultaneous implant placement with tri-cortical ridge augmentation using chin cortical bone struts in anterior atrophic maxilla
Intervention Type
Procedure
Intervention Name(s)
Computer guided simultaneous implant placement with tri-cortical ridge augmentation using chin cortical bone struts
Intervention Description
fabrication of surgical guide to aid in chin bone harvesting and another guide to help for accurate placement and simultaneous placement in anterior maxillary defective area.
Primary Outcome Measure Information:
Title
Bone quality (change in bone density)
Description
Serial CBCT scans measuring change in bone density in grey value
Time Frame
T0 before surgery, T1 immediately after surgery, T2 after 6 month
Secondary Outcome Measure Information:
Title
Bone quantity (bone formation "height and width")
Description
Serial CBCT scans (T0 before surgery, T1 immediately after surgery, T2 after 6 month) measuring bone quantity in mm
Time Frame
T0 before surgery, T1 immediately after surgery, T2 after 6 month
Title
Implant stability
Description
measure primary stability immediately after implant placement and in the second surgery using Osstell device (ISQ value of 1-100)
Time Frame
day of the surgery and at 6 month
Title
Accuracy of Plan Transfer
Description
Superimposition of preoperative digital plan and the immediate postoperative CBCT to assess the positional discrepancy of the graft between the digitally plan versus the actual postoperative position will be measured in millimeters three dimensionally (anteroposterior, vertical and lateral position).
Time Frame
1-3 days postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with single or Multiple missing Maxillary Anterior Teeth with vertically and horizontally defective ridges having adequate soft tissue ample. Patients who gave their consent for this trial. Males and females will be included. Exclusion Criteria: Patients on bisphosphonates or drugs altering bone metabolism, within 2 months before initiating the study. Subjected to irradiation in the head and neck area less than 1 year before implantation. Patients allergic to drugs used in the study. Patients having a history of a major medical condition (ASA 3,4) Untreated periodontitis. Poor oral hygiene and motivation. Uncontrolled diabetes. Pregnant or nursing. Substance abuse. Psychiatric problems or unrealistic expectations. Severe bruxism or clenching. Immunosuppressed or immunocompromised patients. Treated or under treatment with intravenous amino-bisphosphonates. Active infection or severe inflammation in the area intended for implant placement. Unable to open mouth sufficiently to accommodate the surgical tooling. Patients participating in other studies, if the present protocol could not be properly followed. Referred only for implant placement or unable to attend a 5-year follow-up.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed MA Abdelrahman, BDS
Phone
01020753355
Ext
002
Email
ahmed_abdelrahman@dentistry.cu.edu.eg
Facility Information:
Facility Name
Faculty of Dentistry, Cairo University
City
Cairo
ZIP/Postal Code
11553
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Computer Guided Simultaneous Implant Placement With Tri-cortical Ridge Augmentation Using Chin Cortical Bone Struts in Anterior Atrophic Maxilla: A Case Series

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