- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07460076
Immediate Implant Placement With Autogenous Maxillary Tuberosity Graft in the Esthetic Zone (TUBERO-IMPLANT)
Clinical and Esthetic Outcomes of Immediate Implant Placement With Autogenous Maxillary Tuberosity Graft in the Esthetic Zone: A Prospective Case Series
Immediate implant placement in the esthetic zone is often associated with buccal bone deficiency, which may compromise esthetic outcomes and long-term implant stability. Autogenous bone graft harvested from the maxillary tuberosity provides corticocancellous bone with favorable biological properties and may help reconstruct the buccal bone plate during immediate implant placement.
This prospective case series aims to evaluate the clinical and esthetic outcomes of immediate implant placement combined with autogenous maxillary tuberosity graft in the esthetic zone. The primary outcomes include buccal bone thickness measured on cone-beam computed tomography (CBCT), facial soft tissue thickness measured clinically, and the pink esthetic score (PES) after implant restoration.
Study Overview
Status
Intervention / Treatment
Detailed Description
Immediate implant placement has become a widely accepted treatment modality in the esthetic zone. However, the presence of buccal bone defects following tooth extraction may negatively affect peri-implant tissue stability and esthetic outcomes. Autogenous bone graft harvested from the maxillary tuberosity has been proposed as a reliable grafting material due to its corticocancellous structure and high osteogenic potential.
This prospective interventional case series aims to evaluate the effectiveness of autogenous maxillary tuberosity graft used in conjunction with immediate implant placement in the esthetic zone. Patients requiring extraction and implant placement in the maxillary esthetic region will be treated with immediate implant placement and augmentation using a two-layer autogenous graft harvested from the maxillary tuberosity, consisting of cortical bone and connective tissue.
Clinical and radiographic outcomes will be assessed during follow-up. Buccal bone thickness will be evaluated using cone-beam computed tomography (CBCT). Facial soft tissue thickness will be measured clinically. Esthetic outcomes will be assessed using the pink esthetic score (PES) following definitive prosthetic restoration.
The results of this study are expected to provide clinical evidence regarding the effectiveness of maxillary tuberosity autogenous grafts for improving peri-implant tissue stability and esthetic outcomes in immediate implant placement.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Duy Anh Tran, DDS
- Phone Number: +84 868324216
- Email: tranduyanhump17@gmail.com
Study Locations
-
-
Ho Chi Minh
-
Ho Chi Minh City, Ho Chi Minh, Vietnam, 700000
- Recruiting
- University of Medicine and Pharmacy at Ho Chi Minh City
-
Contact:
- Duy Anh Tran, DDS
- Phone Number: +84 868324216
- Email: tranduyanhump17@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18 years or older
- Patients requiring single implant placement in the maxillary esthetic zone
- Indication for immediate implant placement following tooth extraction
- Presence of a buccal bone defect requiring augmentation with an autogenous maxillary tuberosity bone graft
- Adequate oral hygiene and ability to maintain postoperative care
- Willingness to participate in the study and provide informed consent
Exclusion Criteria:
- Uncontrolled sHistory of radiotherapy in the head and neck region ystemic diseases
- History of radiotherapy in the head and neck region
- Active periodontal disease or untreated oral infection
- Heavy smoking (more than 10 cigarettes per day)
- Pregnancy or lactation
- Severe parafunctional habits
- Insufficient bone volume preventing implant placement with the planned protocol
- Patients unable to attend follow-up visits
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Immediate Implant With Maxillary Tuberosity Graft
Patients receiving immediate implant placement in the maxillary esthetic zone combined with autogenous bone graft harvested from the maxillary tuberosity to reconstruct the buccal bone plate.
|
Immediate implant placement in the maxillary esthetic zone combined with autogenous bone graft harvested from the maxillary tuberosity.
The graft is used to reconstruct the buccal bone plate and improve peri-implant tissue stability and esthetic outcomes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Buccal Bone Thickness
Time Frame: 6 months after implant placement
|
Buccal bone thickness around the implant measured on cone-beam computed tomography (CBCT) in the mid-facial aspect of the implant site.
|
6 months after implant placement
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Facial Soft Tissue Thickness
Time Frame: 6 months after implant placement
|
Facial peri-implant soft tissue thickness measured clinically at the mid-facial aspect of the implant site.
|
6 months after implant placement
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pink Esthetic Score (PES)
Time Frame: 6 months after implant placement
|
Esthetic evaluation of peri-implant soft tissue using the Pink Esthetic Score (PES) assessed after prosthetic restoration.
|
6 months after implant placement
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MT-BLOCK-GRAFT-IMPLANT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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