Immediate Implant Placement With Autogenous Maxillary Tuberosity Graft in the Esthetic Zone (TUBERO-IMPLANT)

March 4, 2026 updated by: Tran Duy Anh, University of Medicine and Pharmacy at Ho Chi Minh City

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Vietnam
    • Ho Chi Minh
      • Ho Chi Minh City, Ho Chi Minh, Vietnam, 700000
        • Recruiting
        • University of Medicine and Pharmacy at Ho Chi Minh City
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: Immediate Implant Placement With Maxillary Tuberosity Autogenous Graft
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Medicine and Pharmacy at Ho Chi Minh City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MT-BLOCK-GRAFT-IMPLANT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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