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

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05731063
Collaborator
(none)
10
1
1
14
0.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Computer guided simultaneous implant placement with tri-cortical ridge augmentation using chin cortical bone struts
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Computer Guided Simultaneous Implant Placement With Tri-cortical Ridge Augmentation Using Chin Cortical Bone Struts in Anterior Atrophic Maxilla: A Case Series
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: Ridge augmentation surgery

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

Procedure: Computer guided simultaneous implant placement with tri-cortical ridge augmentation using chin cortical bone struts
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.

Outcome Measures

Primary Outcome Measures

  1. Bone quality (change in bone density) [T0 before surgery, T1 immediately after surgery, T2 after 6 month]

    Serial CBCT scans measuring change in bone density in grey value

Secondary Outcome Measures

  1. Bone quantity (bone formation "height and width") [T0 before surgery, T1 immediately after surgery, T2 after 6 month]

    Serial CBCT scans (T0 before surgery, T1 immediately after surgery, T2 after 6 month) measuring bone quantity in mm

  2. Implant stability [day of the surgery and at 6 month]

    measure primary stability immediately after implant placement and in the second surgery using Osstell device (ISQ value of 1-100)

  3. Accuracy of Plan Transfer [1-3 days postoperatively]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Dentistry, Cairo University Cairo Egypt 11553

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Mohamed Abdrabelnaby Abdelrahman, Dentist, Cairo University
ClinicalTrials.gov Identifier:
NCT05731063
Other Study ID Numbers:
  • 2722
First Posted:
Feb 16, 2023
Last Update Posted:
Feb 16, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 16, 2023