NCT07784075

Brief Summary

Adding local vancomycin to xenografts greatly benefits stability, bone density, and limits marginal bone loss in dental implants in infected socket.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

July 10, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

6 months

First QC Date

August 10, 2026

Last Update Submit

August 20, 2026

Conditions

Immediate Implant Placement in Chronic Infected Socket

Keywords

Immediate dental implantInfected SocketBone preservation,Xenograft,Vancomycin.Local delivery antibiotic

Outcome Measures

Primary Outcomes (1)

  • implant stability

    Changes in ISQ utilizing the Ostell ™ system

    baseline, 1, 6 months after implant placement

Secondary Outcomes (2)

  • bone marginal level

    baseline, 1, 6 and 9 months after treatment

  • measure bone density

    baseline, 1, 6 and 9 months after treatment

Study Arms (2)

Xenograft plus vancomycin (Gp I)

EXPERIMENTAL

immediate dental implants with a mixture of xenograft and vancomycin.

Procedure: immediate dental implants Placement in Chronic Infected Socket

Xenograft only (Gp II)

PLACEBO COMPARATOR

immediate dental implants with xenograft only.

Procedure: immediate dental implants Placement in Chronic Infected Socket

Interventions

immediate dental implants Placement in Chronic Infected SocketPROCEDURE

(Clinical and Radiographic Study)

Xenograft only (Gp II)Xenograft plus vancomycin (Gp I)

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • a badly decayed, hopeless tooth with periapical infection indicated for extraction and seeking implant placement

You may not qualify if:

  • Acute infected socket.
  • Any socket with more than four wall defects.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dental Medicine,Al-Azhar University

Asyut, 0000, Egypt

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Clinical and Radiographic Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of oral medicine ,periodontology departement

Study Record Dates

First Submitted

August 10, 2026

First Posted

August 25, 2026

Study Start

July 10, 2024

Primary Completion

January 1, 2025

Study Completion

April 1, 2025

Last Updated

August 25, 2026

Record last verified: 2026-08

Locations

EG(1)