NCT06875830

Brief Summary

Statement of the problem: Immediate implant placement is faced with several problems. One of the most important issues is dealing with defects in the buccal plate of bone in the esthetic zone. Aim: The aim of this study is to assess the buccal bone thickness after augmentation with titanium mesh and xenograft upon flapless immediate implant placement.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
Mar 2025Sep 2026

Study Start

First participant enrolled

March 6, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

January 13, 2026

Status Verified

March 1, 2025

Enrollment Period

1.3 years

First QC Date

March 9, 2025

Last Update Submit

January 11, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Buccal bone thickness

    assessment of the Buccal bone thickness in mm using CBCT

    at baseline, 6 and 12 months

Secondary Outcomes (2)

  • Soft tissue thickness

    at baseline 6 and 12 months

  • Keratinized tissue width

    at baseline, 6 and 12 months

Study Arms (2)

immediate implant with collagen membrane

ACTIVE COMPARATOR

immediate implant placement will be done and augmentation of the buccal bone will be done with xenograft and collagen membrane

Procedure: collagen membrane

immediate implant with titanium mesh

ACTIVE COMPARATOR

immediate implant placement will be done and augmentation of the buccal bone will be done with xenograft and titanium mesh

Procedure: titanium mesh

Interventions

augmentation of the buccal plate of bone with xenograft and collagen membrane

immediate implant with collagen membrane
titanium meshPROCEDURE

augmentation of the buccal plate of bone with xenograft and titanium mesh

immediate implant with titanium mesh

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who have at least one remaining root or badly decayed tooth in anterior maxilla.
  • Systemically free patients (American Society of Anesthesiologists I; ASA I)
  • Patients aged from 21 to 50 years old
  • Buccal bone partial deficiency (extraction socket type II)
  • Good oral hygiene
  • Accepts the follow-up period (cooperative patients)
  • Patient accepts to provides an informed consent

You may not qualify if:

  • Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits such as bruxism
  • Smokers
  • Pregnant and lactating females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of oral & dental Medicine,Misr international University

Cairo, 123456, Egypt

Location

Study Officials

  • ahmed H Farid, Masters

    Assistant lecturer

    PRINCIPAL INVESTIGATOR

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

Study Record Dates

First Submitted

March 9, 2025

First Posted

March 13, 2025

Study Start

March 6, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

January 13, 2026

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations