Socket-Shield Technique With Immediate Implant

January 4, 2023 updated by: Asrar Moustafa Muftah Althabet, Ain Shams University

Socket-Shield Technique With Immediate Implant Placement for Labial Bone Preservation

Primary Objective:

Evaluate of labial plate of bone changes using immediate implant with the socket shield technique in anterior esthetic zone.

Secondary Objective:

Evaluate of soft tissue changes using the immediate implant with socket shield technique in anterior esthetic zone.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Dental implants have become a standard treatment in the replacement of missing teeth. After tooth extraction and implant placement, resorption of buccal bundle bone can pose a significant complication with often very negative cosmetic impacts. Remodeling of the labial bone plate after extraction is a common challenge that affects the final esthetic outcome especially in the esthetic zone.

In addition to, marked bone loss in the horizontal plane and vertical height of the socket wall occurs during the first year after extraction, and one third of this total bone loss occurs during the first three months.

As the buccal aspect of the dental implant has great importance, especially in the aesthetic zone, because the buccal bone is very thin especially in the anterior maxilla and its resorption can result in recession of the soft tissue.

It was suggested that following tooth extraction, the blood vessels in periodontium to the thin bone walls are severed, thereby causing facial bone plate resorption. Thus, it can be assumed that retaining a root may alter the occurrence of facial bone resorption. Many studies showed that the retention of the decoronated root, vital or endodontically treated as root submerge technique, can preserve the alveolar bone.

Other studies also proved that the placement of the implant in contact with retained root surface preserved the buccal bone and led to good emergence profile, Hürzeler et al. (2010) were the first to demonstrate the socket-shield technique in a study on one beagle dog. Were Modification of original technique was done by many researchers by preserving the palatal bone and proximal bone. The promising result of this study shows socket shield technique as a feasible alternative treatment option for thin buccal plate region area and periodontally healthy teeth.

Flapless technique can decrease the amount of bone resorption. Thus, helping in preservation of the inter-dental papilla. Also, it provides less traumatic surgery, decreased operative time, rapid healing and less postoperative complications.

The socket-shield (SS) technique provides a promising treatment adjunct to better manage these risks and preserve the post-extraction tissues in aesthetically challenging cases. The principle is to prepare the root of a tooth indicated for extraction in such a manner that the buccal / facial root section remains in-situ with its physiologic relation to the buccal plate intact.

The socket shield procedure is a novel technique for post extraction implant placement. Several modifications of partial extraction therapy and simultaneous implant placement have been presented since its inception. In this study we discuss the most contemporary step-by-step surgical technique of the socket shield procedure with detailed illustrations and representative cases.

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.

Study Contact

Study Contact Backup

  • Name: Mohamed Sh El-Mofty, Prof.Dr
  • Phone Number: 00201001431000
  • Email: Mofty@dr.com

Study Locations

  • Egypt
    • Nasr City
      • Cairo, Nasr City, Egypt, 0020
        • Recruiting
        • Ain Shams University
        • Contact:
          • Mohamed Sh El-Mofty, Prof.Dr
          • Phone Number: 00201001431000
          • Email: Mofty@dr.com
        • Contact:

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

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:.1. Healthy adlult patient 2. Age from 20-50 years old. 3 Tooth involved in the esthetic zone. 4. Socket Type I. (Elian et al., 2007) 5. Natural teeth adjacent to the involved tooth should be free from periapcial infection.

6. Sufficient hard and soft tissue volume in vertical and buccolingual direction (Levine et al., 2014) 7. Good oral hygiene. 8. Indication for tooth extraction included :( Degidi et al., 2010)

  • Non-restorable teeth
  • Remaining roots
  • Endodontic failures

Exclusion Criteria :1. Presence of acute dento-alveolar infection of involved tooth.

2. Pregnant and breast feeding. 3. Smokers. (Takamiya et al., 2013) 4. Decision impaired individuals (prisoners, handicapped, and mentally retarded) 5. Vertical or Horizontal root fractures on buccal aspect below bone level. 6. External or internal root resorption.

-

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: Implant intact with shield
Ten patients undergo flapless single immediate implant placement surgery with socket shield technique, the implant is in contact with the shield.
Device: Implant(Flotecno)

The implants It has a tapered body design and Sandblasting with Large grit that facilitates the osseointergration process.

made in Italy Flotecno srl via.Turati,38 20121 MILANO (Italia)
Experimental: Implant not intact with shield
Ten patients undergo flapless single immediate implant placement surgery with socket shield technique, there was a jumping gap more than 2mm between the shield and the implant, in which the gap was grafted with Xenograft.
Device: Implant(Flotecno)

The implants It has a tapered body design and Sandblasting with Large grit that facilitates the osseointergration process.

made in Italy Flotecno srl via.Turati,38 20121 MILANO (Italia)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of labial bone thickness
Time Frame: baseline at day of surgery and after 6 months
With the help of CBCT ;Horizontal bone level measurement: Three horizontal lines are drawn 2, 4, and 6 mm apical to implant platform to outer surface of buccal plate of bone. Facial plate of bone is taken as a reference point and is measured baseline (after implant placement and at 6 months follow up).
baseline at day of surgery and after 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pink esthetic score (PES)
Time Frame: baseline presurgery and after 6 months

Pink esthetic evaluation criteria:

The Pink Esthetic Score is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color and texture. Each variable was assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score.

The mesial and distal papilla were evaluated for completeness, incompleteness or absence. All other variables were assessed by comparison with a reference tooth, i.e., the corresponding tooth (anterior region) or a neighboring tooth (pre-molar region) or evaluate (PES) evaluation before extraction and at six months follow up of involved tooth.
baseline presurgery and after 6 months

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Study Chair: Ahmed A Hassan, Prof.Dr, Ain Shams University
  • Principal Investigator: Asrar M Althabet, MSC, Faculty Of Dentistry Ain Shams University

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 (Actual)

June 1, 2022

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

January 3, 2023

First Submitted That Met QC Criteria

January 4, 2023

First Posted (Estimate)

January 6, 2023

Study Record Updates

Last Update Posted (Estimate)

January 6, 2023

Last Update Submitted That Met QC Criteria

January 4, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • socket shield

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.

Subscribe