NCT05005585

Brief Summary

immediate implant placement with VST technique versus early implant placement with contour augmentation in fresh extraction sockets in the esthetic zone.

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
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

3 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

First Submitted

Initial submission to the registry

August 6, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 13, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

November 18, 2021

Status Verified

November 1, 2021

Enrollment Period

1.1 years

First QC Date

August 6, 2021

Last Update Submit

November 17, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Implant survival

    If there is no pain or tenderness on use, no mobility, no history of exudates and radiographic bone loss is less than 2 mm from initial surgery implant the implant is considered successful

    12 months

Secondary Outcomes (2)

  • Changes in the height and thickness of the labial plate of bone

    12 months

  • Changes in soft tissue height

    12 months

Study Arms (2)

vestibuler socket therapy

EXPERIMENTAL

immediate implant placement in esthatic zone with final crown placement after 2 months with VST technique

Procedure: immediate implant

contour augmentation

EXPERIMENTAL

Early implant placement in esthatic zone with contour augmentation and final crown after 3 months of implant placement

Procedure: immediate implant

Interventions

immediate implant placement with VST technique versus early implant placement with contour augmentation technique

contour augmentationvestibuler socket therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-restorable maxillary teeth in the esthetic zone
  • Intact adjacent teeth
  • Adequate palatal and apical bone that allows achieving implant primary stability.
  • Compromised sockets type II defect (Nicolas Elian 2007)
  • ≥18 years
  • Systemically healthy patients

You may not qualify if:

  • Extraction sockets with acute or chronic infection or with adjacent infected teeth
  • Heavy Smokers \> than 10 cigarettes daily
  • Cancer patients undergoing radiotherapy or chemotherapy during or within the last 6 months.
  • Unmotivated patients to maintain adequate oral hygiene to follow up.
  • Patients with physical disabilities that could affect follow up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Faculty of dentistry Cairo university

Cairo, Giza Governorate, 11865, Egypt

Location

Faculty of dentistry

Cairo, Manial, 12911, Egypt

Location

Iman AbdelWahab Radi

Cairo, 11518, Egypt

Location

MeSH Terms

Interventions

Immediate Dental Implant Loading

Intervention Hierarchy (Ancestors)

Dental Implantation, EndosseousDental ImplantationOral Surgical Procedures, PreprostheticOral Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationDentistryProsthodontics

Study Officials

  • Iman Radi, PHD

    Professor of prosthodontics

    STUDY DIRECTOR
  • AbdelSalam ElAsakry, BDS

    Private Practice

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
outcome assessor isnt involved in the intervension
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: VST with immediate implant placement versus contour augmentation with early implant placement in fresh extraction sockets in esthetic zone.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Prosthodontics, Faculty of Dentistry, Cairo University

Study Record Dates

First Submitted

August 6, 2021

First Posted

August 13, 2021

Study Start

December 1, 2021

Primary Completion

January 1, 2023

Study Completion

April 1, 2023

Last Updated

November 18, 2021

Record last verified: 2021-11

Locations