NCT03264053

Brief Summary

Buccal bone is prone to resorb after tooth extraction specially with immediate tooth implantation which could compromise the esthetics of the patient. socket shield technique retains the buccal aspect of the extracted root fragment which may help in preventing the buccal bone from resorbing and prevent esthetics deterioration

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
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 16, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

August 20, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 28, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 15, 2017

Status Verified

September 1, 2017

Enrollment Period

1 year

First QC Date

August 16, 2017

Last Update Submit

September 14, 2017

Conditions

Keywords

socket shield techniquecrestal bone lossimmediate implanation

Outcome Measures

Primary Outcomes (1)

  • Buccal bone resorption assesed by cone beam computed tomography as a measuring tool

    Measuring buccal bone loss after the procedure comparing between leaving the buccal portion of the root and extracting the whole root

    12 months

Study Arms (2)

SOCKET SHIELD TECHNIQUE

EXPERIMENTAL

Socket shield is the surgical removal of the frontal aspect of the badly broken root and retaining the lingual aspect so as to prevent crestal bone loss with insertion of the dental implant behind it

Device: Socket shield

Conventional immediate implantation

ACTIVE COMPARATOR

Conventional immediate implantation is the surgical removal of the entire badly broken root

Procedure: Conventional immediate implantation

Interventions

Socket shield is the Removal of the lingual portion of the anterior root thus retaining the lingual portion

Also known as: Implant stability
SOCKET SHIELD TECHNIQUE

Conventional immediate implantation

Conventional immediate implantation

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Humans
  • Esthetic area (anterior and first premolars)
  • Intact labial plate
  • Hopeless tooth indicated for extraction and immediate implant placement

You may not qualify if:

  • Implantation after trauma
  • Peri-implantits defects
  • Use of barrier membranes(GBR)
  • Socket preservation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Immediate Dental Implant Loading

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Abdullah A Mattar, A.Lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdullah A Mattar, A. Lecturer

CONTACT

Soha A Moustafa, A. Lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 16, 2017

First Posted

August 28, 2017

Study Start

August 20, 2017

Primary Completion

August 20, 2018

Study Completion

December 1, 2018

Last Updated

September 15, 2017

Record last verified: 2017-09

Locations