NCT04630665

Brief Summary

To achieve esthetic immediate implants a minimum of adequate buccal bone thickness must be present. It was postulated that 2 mm of buccal bone thickness was needed to prevent recession of the buccal plate. However, this was reduced to 1 mm with more ongoing research. In a recent study postulated that a buccal bone thickness less than 1 mm could be sufficient. Scarce literature was found that monitored the ridge alterations following implant placement. In regards to the controversies regarding the minimal initial buccal bone thickness required to perform immediate implant placement, our study aims to monitor the buccal bone thickness and soft tissue changes over a year from implant and prosthetic placement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

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

January 23, 2019

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2022

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

3.8 years

First QC Date

November 9, 2020

Last Update Submit

February 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • buccal bone thickness

    measurement of buccal bone thickness by a specially designed device and cone-beam computed tomography (CBCT) analysis

    1 year

Secondary Outcomes (1)

  • pink esthetic score (PES)

    1 year

Study Arms (2)

thin buccal bone

OTHER

immediate implant placement in thin buccal bone wall socket

Other: immediate implant placement

≥1 buccal bone

OTHER

immediate implant placement in 1 mm or more buccal bone thickness socket

Other: immediate implant placement

Interventions

immediate implant placement in thin and thick buccal bony plates

thin buccal bone≥1 buccal bone

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects who have at least one unrestorable tooth in the esthetic zone that needs to be extracted.
  • Subjects with healthy systemic condition.
  • Availability of bone apical and palatal to the socket to provide primary stability.

You may not qualify if:

  • Patients with signs of acute infection related to the area of interest.
  • Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits.
  • Smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Greater Cairo, 12613, Egypt

Location

Related Publications (2)

  • Merheb J, Vercruyssen M, Coucke W, Beckers L, Teughels W, Quirynen M. The fate of buccal bone around dental implants. A 12-month postloading follow-up study. Clin Oral Implants Res. 2017 Jan;28(1):103-108. doi: 10.1111/clr.12767. Epub 2016 Jan 8.

    PMID: 26749417BACKGROUND
  • El Nahass H, N Naiem S. Analysis of the dimensions of the labial bone wall in the anterior maxilla: a cone-beam computed tomography study. Clin Oral Implants Res. 2015 Apr;26(4):e57-e61. doi: 10.1111/clr.12332. Epub 2014 Jan 23.

    PMID: 24450845BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 9, 2020

First Posted

November 16, 2020

Study Start

January 23, 2019

Primary Completion

November 2, 2022

Study Completion

November 2, 2022

Last Updated

February 23, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share
Shared Documents
SAP, ICF
Time Frame
6 months following publishing

Locations