Socket Shield vs Conventional Immediate Implant

February 5, 2019 updated by: Ahmed Abd El Rahman, Cairo University

Esthetic Zone Socket Shield Technique With Immediate Temporization vs. Conventional Immediate Implant Placement With Immediate Temporization Randomized Clinical Trial

eighteen implants will be placed in patients with non-restorable maxillary teeth in the aesthetic area.the recruited patients will be divided into two groups .group 1 will undergo socket shield technique with immediate temporization ,while group 2 will undergo conventional immediate implant placement with immediate temporization. to compare bone loss and aesthetic outcomes in the two techniques.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of Oral and Dental Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with non-restorable maxillary anterior teeth in the esthetic zone indicated for implant placement.
  • Both sexes.
  • No intraoral soft and hard tissue pathology
  • No systemic condition that contraindicate implant placement

Exclusion Criteria:

  • Heavy smokers more than 20 cigarettes per day.
  • Patients with systemic disease that may affect normal healing.
  • Psychiatric problems
  • Disorders to implant are related to history of radiation therapy to the head and neck neoplasia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: socket shield technique
socket shield technique with immediate temporization
Procedure: socket shield technique
socket shield technique with immediate temporization
Active Comparator: conventional immediate implant
conventional implant placement with immediate temporization
Procedure: conventional immediate implant placement with immediate temporization
conventional immediate implant placement with immediate temporization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
implant stability
Time Frame: immediately after implant placement
implant stability will be measured using osstell device
immediately after implant placement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of bone loss
Time Frame: after 3 month from implant insertion.
Will be measured using linear measurements from CBCT
after 3 month from implant insertion.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
pink aesthetic score
Time Frame: immediately after implant placement and three month later

The gingival response to a anterior esthetic evaluation is assessed by the Pink Esthetic Score (PES) from clinical photography according to six variables scored from 0→2:

  1. Mesial & distal papillae,
  2. Keratinized gingiva,
  3. Curvature of the gingival margin,
  4. Level of the gingival margin,
  5. Root convexity(torque),
  6. Scar formation.
immediately after implant placement and three month later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 15, 2019

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

June 9, 2018

First Submitted That Met QC Criteria

July 3, 2018

First Posted (Actual)

July 16, 2018

Study Record Updates

Last Update Posted (Actual)

February 6, 2019

Last Update Submitted That Met QC Criteria

February 5, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 03021984

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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