NCT05436158

Brief Summary

There is an angle between the intersection of the incisal long axis perpendicular to the palate or the occlusal plane, and the long axis of the root. When this relation is shifted more palatal, where the incisal plane line will be at the cingulum position or slightly palatal to it, it is named the safe angle position. The more palatal relocation to the cingulum is performed according to the availability of palatal bone, the occlusion with the opposing dentition, the type of the restoration (screw vs cemented). The possibility of having a specific safe angle to place implants opens new interesting perspectives for immediate placement of dental implants. The aim of the present study was to demonstrate how immediate implants in the safe angle position can be predictably achieve proper implant positioning, better esthetics and emergence profile as well as less stresses on the implant.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

May 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 28, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

June 28, 2022

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

June 19, 2022

Last Update Submit

June 23, 2022

Conditions

Keywords

Immediate dental implantsanterior maxillasafe angle position

Outcome Measures

Primary Outcomes (2)

  • presence of the implant in the safe angle

    binary (Y/N) from CBCT

    6 months

  • use of angled or straight abutment

    Binary (straight/angled)

    6 months

Secondary Outcomes (1)

  • Pink Esthetic Score

    6 months

Interventions

After assessing the CBCT of patients, the immediate implants will be assessed if they were placed in the safe zone. the safe zone is described as; that there is an angle between the intersection of the incisal long axis perpendicular to the palate or the occlusal plane, and the long axis of the root. When this relation is shifted more palatal, where the incisal plane line will be at the cingulum position or slightly palatal to it, it is named the safe angle position. The more palatal relocation to the cingulum is performed according to the availability of palatal bone, the occlusion with the opposing dentition, the type of the restoration (screw vs cemented).

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with immediate implants in the anterior region

You may qualify if:

  • Patients with immediate implants in the anterior region
  • Patient with preoperative and postoperative CBCT
  • Provide informed consent.

You may not qualify if:

  • patients without a preoperative CBCT.
  • patients without an informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

International Dental Continuing Education

Cairo, Maadi, 11728, Egypt

RECRUITING

Faculty of Dentistry, Cairo University

Cairo, Manial, 35855, Egypt

RECRUITING

Study Officials

  • Noha A Ghallab, PhD

    Professor of Oral Medicine & Periodontology

    STUDY CHAIR
  • Ahmed I Abou- El-Fettouh, MSc

    MIU

    PRINCIPAL INVESTIGATOR
  • Abdelrahman Zohny, BDs

    MIU

    PRINCIPAL INVESTIGATOR
  • Nael M Adel, BDs

    MIU

    PRINCIPAL INVESTIGATOR
  • Mariam S Abdelmalak, BDs

    MIU

    PRINCIPAL INVESTIGATOR
  • Nesma M Shemais, PhD

    Lecturer of Oral Medicine & Periodontology, Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Noha A Ghallab, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in the department of Oral Medicine & Periodontology

Study Record Dates

First Submitted

June 19, 2022

First Posted

June 28, 2022

Study Start

May 1, 2022

Primary Completion

August 1, 2022

Study Completion

September 1, 2022

Last Updated

June 28, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations