NCT07449806

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Sep 2025Sep 2026

Study Start

First participant enrolled

September 5, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2026

Expected
Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

February 27, 2026

Last Update Submit

March 4, 2026

Conditions

Alveolar Bone LossTooth Extraction Status NosImmediate Implant Placement

Keywords

immediate implant placementtype II extraction socketesthetic zone.xenograftrandomized controlled clinical trial

Outcome Measures

Primary Outcomes (1)

  • Labial Bone Plate Thickness Change

    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 Outcomes (1)

  • Peri-implant mucosal level (PML)

    6 months post-implant placement

Other Outcomes (1)

  • Clinical assessment of Pink Esthetic score

    6 months post-implant placement

Study Arms (2)

Medpark S1 xenograft

EXPERIMENTAL

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

bio-Oss xenograft

EXPERIMENTAL

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

Interventions

Immediate Implant Placement with Medpark S1 xenograftPROCEDURE

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

Medpark S1 xenograft
Immediate Implant Placement with bio-Oss xenograftPROCEDURE

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

bio-Oss xenograft

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Egypt

RECRUITING

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Basma Gamal, BDS

CONTACT

+20 10 10231477basmagamal816@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
postgraduate researcher

Study Record Dates

First Submitted

February 27, 2026

First Posted

March 4, 2026

Study Start

September 5, 2025

Primary Completion

May 5, 2026

Study Completion (Estimated)

September 25, 2026

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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

Locations

EG(1)