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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

26

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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

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)

September 5, 2025

Primary Completion (Estimated)

May 5, 2026

Study Completion (Estimated)

September 25, 2026

Study Registration Dates

First Submitted

February 27, 2026

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 4, 2026

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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