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Clinical Trials/NCT06648135
NCT06648135
Not yet recruiting
Not Applicable

a Novel Socket Evaluation System and Its Impact on Bone Formed Labial to Bone Immediate Anterior Implants. A 1-year Clinical Trial.

Misr International University1 site in 1 country25 target enrollmentMarch 1, 2026

Overview

Phase
Not Applicable
Intervention
Immediate implants with bone grafts
Conditions
Immediate Implant Placement
Sponsor
Misr International University
Enrollment
25
Locations
1
Primary Endpoint
Bone labial to the implant
Status
Not yet recruiting
Last Updated
3 months ago

Overview

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.

Detailed Description

Bone formation labial to the immediate implant is not related to the initial thick- ness of the labial plate of bone, rather than the initial labio-palatal socket dimension. this study aims to evaluate the bone formed labial to the implant following a Novel Socket Evaluation System.

Registry
clinicaltrials.gov
Start Date
March 1, 2026
End Date
July 1, 2026
Last Updated
3 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Abo El Futtouh

Exectutive and Clinical director of Implantology Master program, MIU

Misr International University

Eligibility Criteria

Inclusion Criteria

  • 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)

Exclusion Criteria

  • 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.

Arms & Interventions

Bone grafts

Immediate implant placed with bone grafts in the labial gap

Intervention: Immediate implants with bone grafts

No bone grafts

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

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

Outcomes

Primary Outcomes

Bone labial to the implant

Time Frame: one year

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

Secondary Outcomes

  • Bone area at the Interproximal component(preoperative)

Study Sites (1)

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