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Assessment of Digital and Clinical Workflow Using Patient Specific Sticky Bone /Implant Housing PEEK Shell in Anterior Atrophic Maxilla: A Case Series

Primary Purpose

Ridge Augmentation

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
sticky bone housed in PEEK Shell
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 - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with Multiple missing Maxillary Anterior Teeth with horizontally defective ridges having adequate soft tissue ample. Patients who already gave their consent for this trial. Males and females both 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 region within the last year Patients allergic to drugs used in the study like ( Articaine, Lidocaine, 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. 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

Augmented group

Arm Description

Patient Specific Sticky Bone /Implant Housing PEEK Shell in Anterior Atrophic Maxilla with simultaneous implant placement

Outcomes

Primary Outcome Measures

Bone gain
Serial CBCT images (T0 before surgery, T1 immediately after surgery and T2 after 6 months) measuring bone gain in mm

Secondary Outcome Measures

Clinically successful osseointegrated implant
measuring primary stability immediately after implant placement and in the second surgery using Ostell device
Accuracy of Plan Transfer
superimposing the preoperative CBCT and the immediately postoperative CBCT to measure the accuracy of the procedure compared to the plan done
Bone Quality
Serial CBCT images (T0 before surgery, T1 immediately after surgery and T2 after 6 months) measuring bone quality in Hounsfield units

Full Information

First Posted
November 13, 2022
Last Updated
November 18, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05624697
Brief Title
Assessment of Digital and Clinical Workflow Using Patient Specific Sticky Bone /Implant Housing PEEK Shell in Anterior Atrophic Maxilla: A Case Series
Official Title
Assessment of Digital and Clinical Workflow Using Patient Specific Sticky Bone /Implant Housing PEEK Shell in Anterior Atrophic Maxilla: A Case Series
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 25, 2022 (Anticipated)
Primary Completion Date
November 25, 2023 (Anticipated)
Study Completion Date
May 25, 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 horizontally deficient anterior maxillary areas will be recruited and a preoperative CBCT will be done. The plan is to graft the defective ridges with simultaneously placing dental implants using a PEEK shell that will be specifically designed, constructed and 3D printed to act as a surgical guide for osteotomy drilling and implant placement as well as housing both the implant and the sticky bone (using a mixture of autogenous bone harvested from the symphysis area and xenograft both mixed with plasmatic matrix); that will be added to augment the defective ridge; the PEEK shell will also act as a barrier membrane for Guided Bone Regeneration and will add more stability to the placed implants that will be fixed to the PEEK shell occlusally with a Ti - based abutment. Primary stability will be measured using Ostell and an immediate postoperative CBCT will be done and superimposed on the preoperative CBCT and an accuracy of plan transfer will be measured to make sure the planning was followed accurately. Then 6 months later, another CBCT will be done to check the bone gain and quality and a second surgery will be done to remove the PEEK shell and proceed with the conventional implant prosthetic phase.

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
Augmented group
Arm Type
Other
Arm Description
Patient Specific Sticky Bone /Implant Housing PEEK Shell in Anterior Atrophic Maxilla with simultaneous implant placement
Intervention Type
Procedure
Intervention Name(s)
sticky bone housed in PEEK Shell
Intervention Description
Patient specific Sticky Bone/Implant housing PEEK shell in Anterior Atrophic Maxilla
Primary Outcome Measure Information:
Title
Bone gain
Description
Serial CBCT images (T0 before surgery, T1 immediately after surgery and T2 after 6 months) measuring bone gain in mm
Time Frame
T0 before surgery, T1 immediately after surgery and T2 after 6 months
Secondary Outcome Measure Information:
Title
Clinically successful osseointegrated implant
Description
measuring primary stability immediately after implant placement and in the second surgery using Ostell device
Time Frame
At the day of the surgery and 6 months after first surgery
Title
Accuracy of Plan Transfer
Description
superimposing the preoperative CBCT and the immediately postoperative CBCT to measure the accuracy of the procedure compared to the plan done
Time Frame
1-3 days postoperatively
Title
Bone Quality
Description
Serial CBCT images (T0 before surgery, T1 immediately after surgery and T2 after 6 months) measuring bone quality in Hounsfield units
Time Frame
0 before surgery, T1 immediately after surgery and T2 after 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with Multiple missing Maxillary Anterior Teeth with horizontally defective ridges having adequate soft tissue ample. Patients who already gave their consent for this trial. Males and females both 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 region within the last year Patients allergic to drugs used in the study like ( Articaine, Lidocaine, 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. 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
Mohamed MS Bahgat, BDS
Phone
01007419224
Ext
002
Email
mohamed.samy@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

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Assessment of Digital and Clinical Workflow Using Patient Specific Sticky Bone /Implant Housing PEEK Shell in Anterior Atrophic Maxilla: A Case Series

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