NCT06648135

Brief Summary

The anterior maxilla is a particularly challenging area for immediate implant placement due to its thin buccal bone walls. These walls are more susceptible to resorption after tooth extraction, which can lead to significant bone loss and inadequate support for an implant. However, Different socket dimension may affect the amount of bone formed labial to the implant, regardless of the garfting procedure.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
0mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress87%
Mar 2026Jul 2026

First Submitted

Initial submission to the registry

October 16, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2024

Completed
1.4 years until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

October 16, 2024

Last Update Submit

January 27, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Bone labial to the implant

    measured at three levels 0, 2, and 5 mm below the labial bone crest after one year. Using fusion software.

    one year

Secondary Outcomes (1)

  • Bone area at the Interproximal component

    preoperative

Study Arms (2)

Bone grafts

Immediate implant placed with bone grafts in the labial gap

Procedure: Immediate implants with bone grafts

No bone grafts

Immediate implant placed without bone grafts or any grafting substitutes in the labial gap

Procedure: Immediate implant placed without bone grafts or any grafting substitutes in the labial gap

Interventions

Immediate implants with bone grafts

Bone grafts

Immediate implant placed without bone grafts or any grafting substitutes in the labial gap

No bone grafts

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic

You may qualify if:

  • Immedaite implants in anterior maxilla
  • thick gingival phenotype
  • intact but thin labial plate of bone (≤1mm)
  • sufficient apical bone to attain implant primary stability (a minimum of 35 Ncm insertion torque)

You may not qualify if:

  • smokers
  • pregnant women
  • patients with systemic disease
  • patients with parafunctional habits such as bruxism or clenching,
  • infected socket
  • periapical pathosis
  • history of radiotherapy or chemotherapy within the past 2 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Dental Clinic Educational centre

Cairo, Egypt

Location

MeSH Terms

Interventions

Bone Transplantation

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsOrthopedic ProceduresSurgical Procedures, OperativeTransplantation

Central Study Contacts

Ahmed I Aboul Fettouh, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
5 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Exectutive and Clinical director of Implantology Master program, MIU

Study Record Dates

First Submitted

October 16, 2024

First Posted

October 18, 2024

Study Start

March 1, 2026

Primary Completion

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations