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

NCT05731063 | Unknown

• 1 other identifier: 2722
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Ridge Augmentation

Outcome Measures

Primary Outcomes (1)

• Bone quality (change in bone density)

  Serial CBCT scans measuring change in bone density in grey value

  T0 before surgery, T1 immediately after surgery, T2 after 6 month

Secondary Outcomes (3)

• Bone quantity (bone formation "height and width")

  T0 before surgery, T1 immediately after surgery, T2 after 6 month

• Implant stability

  day of the surgery and at 6 month

• Accuracy of Plan Transfer

  1-3 days postoperatively

Study Arms (1)

Ridge augmentation surgery

OTHER

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

Interventions

Computer guided simultaneous implant placement with tri-cortical ridge augmentation using chin cortical bone struts PROCEDURE

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.

Ridge augmentation surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, 11553, Egypt

RECRUITING

Central Study Contacts

Ahmed MA Abdelrahman, BDS

CONTACT

01020753355; ahmed_abdelrahman@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: February 16, 2023
• Study Start: August 27, 2023
• Primary Completion: February 27, 2024
• Study Completion: May 30, 2024
• Last Updated: September 6, 2023

Record last verified: 2023-09

Locations

EG (1)