Assessment of Labial Plate Thickness After Immediate Implant Placement Using Two Different Xenografts in the Esthetic Zone

March 4, 2026 updated by: Basma Gamal Mohamed Ahmed

Assessment of Labial Plate Thickness After Immediate Implant Placement in Type II Extraction Sockets Using Two Different Xenografts in the Esthetic Zone: a Randomized Controlled Clinical Trial

This randomized clinical trial aims to evaluate labial bone plate changes following immediate implant placement in Type II extraction sockets using two different xenograft materials and de-epithelialized free gingival graft in the esthetic zone . Patients requiring extraction and immediate implant placement will be randomly allocated into two groups according to the xenograft material used for defect grafting. Clinical and radiographic outcomes will be assessed to determine dimensional bone changes and implant success

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 in the esthetic zone has become a predictable treatment modality aiming to reduce treatment time while preserving alveolar bone and soft tissue architecture. However, dimensional alterations of the labial bone plate remain a clinical concern, particularly in Type II extraction sockets.

The present randomized controlled clinical trial will compare the effect of two different xenograft materials and de-epithelialized free gingival graft used for defect grafting during immediate implant placement. Eligible patients indicated for tooth extraction and immediate implant placement will be randomly assigned into two parallel groups based on the grafting material used.

Clinical evaluation and standardized radiographic assessment using CBCT will be performed to measure labial plate thickness changes, peri-implant bone stability, and implant success outcomes over a defined follow-up period. The findings of this study aim to provide clinical evidence regarding the most effective xenograft material for preserving peri-implant hard tissue contours in the esthetic zone

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.
26

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

  • Egypt
      • Alexandria, Egypt
        • Recruiting
        • Faculty of Dentistry, Alexandria University, Egypt
        • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with one or more non-restorable teeth or remaining roots without signs of acute infection in the maxillary anterior region.
  • Type II extraction sockets.
  • Sufficient bone (>3 mm) apically and palatally to allow for proper implant positioning with sufficient primary stability (≥ 30 N cm).
  • Good compliance.

Exclusion Criteria:

  • Teeth with current acute periapical infection.
  • Medically compromised patients.
  • Heavy smokers (smoking of more than 10 cigarettes per day ).
  • Alcohol or drug abuse.
  • Patients undergoing chemotherapy and radiotherapy.
  • Poor oral hygiene.
  • Vulnerable groups (pregnant females and decision- impaired individual).

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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: Medpark S1 xenograft
Patients undergoing immediate implant placement in Type II extraction sockets with defect grafting using Medpark S1 xenograft .
Procedure: Immediate Implant Placement with Medpark S1 xenograft
Immediate implant placement in Type II extraction sockets, with gap grafting using Medpark S1 xenograft .
Experimental: bio-Oss xenograft
Patients undergoing immediate implant placement in Type II extraction sockets with defect grafting using bio-Oss xenograft.
Procedure: Immediate Implant Placement with bio-Oss xenograft
Immediate implant placement in Type II extraction sockets, with gap grafting using bio-Oss xenograft

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
Labial Bone Plate Thickness Change
Time Frame: 6 months post-implant placement
Dimensional changes of the labial alveolar bone plate will be measured using standardized CBCT images to assess the effectiveness of the two xenograft materials in preserving bone contour
6 months post-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
Peri-implant mucosal level (PML)
Time Frame: 6 months post-implant placement
Intraoral scanning will be performed preoperative, immediate postoperative (baseline) and six months postoperatively. The 3D software will be used to align the baseline and six month models using the best-fit algorithm of the software to perfect the superimposition process. The superimposed models will be assessed using specific software, where the measurements will be performed to compare soft tissue outcomes between the two xenograft materials
6 months post-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
Clinical assessment of Pink Esthetic score
Time Frame: 6 months post-implant placement
Seven variables will be scored: mesial papilla, distal papilla, to curvature of the facial mucosa, level of the facial mucosa and soft tissue color, and texture of facial gingiva at the implant site. A score of 0, 1, or 2 will be given to each parameter obtain a final score of 14 minimum score 0,maximum score 14 higher score means better
6 months post-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.
Basma Gamal Mohamed Ahmed

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.
September 5, 2025

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.
May 5, 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.
September 25, 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).
February 27, 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.
February 27, 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 4, 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 6, 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.
  • 1077-05/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This study is a randomized clinical trial designed to evaluate labial bone plate preservation following immediate implant placement in Type II extraction sockets using two different xenograft materials in the esthetic zone. Eligible participants will be randomly assigned to one of two parallel groups based on the xenograft material used for gap grafting. Clinical and radiographic assessments will be conducted to monitor dimensional changes of the labial bone plate, peri-implant tissue health, and implant success over a six-month follow-up period. All procedures will be performed under standard clinical protocols at the Faculty of Dentistry, Alexandria University

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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