: SOCKET SHIELD TECHNIQUE VERSUS EMPTY SOCKET TECHNIQUE

December 10, 2016 updated by: Ahmed Gamal Khater Ali, Cairo University

IMMEDIATE IMPLANT PLACEMENT IN THE ESTHETIC ZONE: SOCKET SHIELD TECHNIQUE VERSUS EMPTY SOCKET TECHNIQUE FOR PRESERVATION OF LABIAL ALVEOLAR BONE INTEGRITY

To evaluate the clinical and radiographic outcomes of socket shield technique compared with conventional immediate implant placement.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To evaluate the clinical and radiographic outcomes of socket shield technique compared with conventional immediate implant placement.

PICO

  • P: patient require immediate dental implant placement for esthetic consideration
  • I: socket shield technique
  • C: conventional immediate implant placement
  • O:

Outcome name Measuring device Measuring unit Primary outcome Vertical and horizontal bone level Cone beam Computer Tomography (CBCT) Millimeter Secondary outcome (a) Pocket probing depth Periodontal probe Millimeter Secondary outcome (b) Labial Alveolar crestal bone height compared with the lingual side Cone beam Computer Tomography (CBCT) Millimeter

Study Type

Interventional

Enrollment (Anticipated)

20

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.

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with remaining roots in the esthetic zone with intact periodontal condition indicated for extraction.
  2. Physically able to tolerate conventional surgical and restorative procedures
  3. Signing of an informed consent form
  4. Implant insertion torque > 32 N cm with good primary stability

Exclusion Criteria:

  1. Systemic diseases contraindicating implant placement eg uncontrolled diabetes
  2. Severe bruxism
  3. Active infection in the teeth to be treated
  4. Vertical root fractures with displacement in the teeth of the surgical area

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: socket shield (A)
  1. Following local anesthetic infiltration opposite to the root to be extracted the root is sectioned in a mesiodistal direction along its long axis as far apical as possible.
  2. After sectioning the root into labial and palatal halves, the palatal half is removed with preservation of the labial root section.
  3. The labial half is prepared to be Flushing or 1mm above the labial alveolar crest. Then thinned slightly to a concave contour in an apico-coronal and mesiodistal direction.
  4. The implant will be inserted in place of the palatal half with the labial surface of the implant facing the labial root shield (root-implant interface)

primary closure will not be attempted as the patients will undergo immediate non-functioning provisionization.
Procedure: implant placement
implant placement
Active Comparator: conventional immediate implant (B)
  1. Following local anesthetic infiltration opposite to the root to be extracted non traumatic extraction of the tooth or remaining root by periotome.
  2. The implant fixture will be inserted in the empty socket by conventional manner.

primary closure will not be attempted as the patients will undergo immediate non-functioning provisionization.
Procedure: implant placement
implant placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vertical and horizontal bone level
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Pocket probing depth
Time Frame: 9 months
9 months
Labial Alveolar crestal bone height compared with the lingual side
Time Frame: 9 months
9 months

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Director: Mohamed Galal G. Beheiri, professor, senior supervisor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2016

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

December 10, 2016

First Submitted That Met QC Criteria

December 10, 2016

First Posted (Estimate)

December 14, 2016

Study Record Updates

Last Update Posted (Estimate)

December 14, 2016

Last Update Submitted That Met QC Criteria

December 10, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Cairoshi-con

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on Dental Implant Placement

Clinical Trials on implant placement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe