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NCT Number: NCT07449806

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

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Egypt

Location status: Recruiting

Location contact

Basma Gamal, BDS

CONTACT

[email protected]

+20 10 10231477

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Immediate Implant Placement with Medpark S1 xenograft

Procedure

Immediate implant placement in Type II extraction sockets, with gap grafting using Medpark S1 xenograft .

Immediate Implant Placement with bio-Oss xenograft

Procedure

Immediate implant placement in Type II extraction sockets, with gap grafting using bio-Oss xenograft

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Basma Gamal, BDS

CONTACT

[email protected]

+20 10 10231477

Sponsors and collaborators

Lead sponsor

Basma Gamal Mohamed Ahmed

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 4, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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