Comparison of Peri-implant Tissues Using Socket Shield Technique Versus Xenograft

February 17, 2020 updated by: Mohamed Atef Abd El Moneium, Cairo University

Comparison of the Dimensional Changes of Hard and Soft Peri-implant Tissues Around Single Immediate Post-Extraction Implants in the Esthetic Zone With Socket Shield Technique Versus Using Xenograft: A Randomized Controlled Clinical Trial

The aim of this study is to clinically and radiographically evaluate the dimensional changes of soft and hard peri-implant tissues around single immediate post-extraction implants in the esthetic zone.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

to compare the efficacy of the socket shield technique in counteracting the dimensional changes of the soft and hard peri-implant tissues to filliing the buccal gap with xenograft.

  • Population (P): Patients with single non-restorable tooth in the esthetic zone.
  • Intervention (I): Immediate implant placement with socket shield technique.
  • Comparator (C): Immediate implant placement and filling the buccal gap with xenograft.
  • Primary Outcome (O): Pink Esthetic Score (PES) (Fürhauser et al., 2005).
  • Time frame: 9 months (Chu et al., 2015).
  • Study design: Randomized controlled clinical trial.

Study Type

Interventional

Enrollment (Anticipated)

22

Phase

  • Phase 3

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, 141
        • Recruiting
        • Cairo university

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient's age was 18 years or older.
  2. Non-restorable tooth in the upper inter-bicuspid area.
  3. Adequate bone volume for the placement of immediate implant.
  4. Following tooth extraction, there was an intact socket bony wall (type I extraction socket).
  5. Primary stability of the implant was achieved at the time of the implant placement.

Exclusion Criteria:

  1. Patients who reported tobacco use in the past 5 years.
  2. Patients who had severe periodontal destruction at the site of implant placement.
  3. The presence of any signs of acute infection in the surgical site or the adjacent two natural teeth.
  4. Patients who had history of any systemic disease that precludes the placement of implants.
  5. Any disease that might affect bone metabolism as osteoporosis.
  6. Patients taking medications that might affect bone turn over as bisphosphonates.
  7. Physically or mentally handicapped patients.
  8. Pregnant females.
  9. Teeth with vertical root fractures on the buccal aspect
  10. Teeth with any other pathologies affecting the buccal part of the root, for example, external or internal resorptions.

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: experimental
immediate implant with socket shield technique
Procedure: socket shield technique
immediate implant placement with buccal part of the root is retained
Active Comparator: control
immediate implant placement with filling the buccal gap with xenograft
Procedure: xenograft
immediate implant placement with filling the buccal gap with xenograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pink esthetic score
Time Frame: 9 months
Pink esthetic score evaluates the soft tissue esthetics around implant supported crowns. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value. The maximum achievable PES is 14. 7 variables are measured: mesial and distal papillae being 0 if absent, 1 if incomplete and 2 if complete. Alveolar process, soft tissue level, contour, texture and color being 0 if major discrepancy, 1 if minor discrepancy and 2 if matches the contralateral
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recession of the buccal peri-implant mucosa
Time Frame: 9 months
measured at the apical zenith of the mucosal margin on the implants after digital superimposition of the optically scanned models as the vertical distance change between the former and the new position of soft tissue margins.
9 months
Corono-apical peri-implant bone dimensional changes
Time Frame: 6 months
measured at the middle of the buccal implant surface after the superimposition of Cone Beam C.T scans as the difference between the former and new vertical distance from the implant platform to the buccal alveolar crest
6 months
Bucco-lingual peri-implant bone dimensional changes
Time Frame: 6 months
measured at middle of the buccal implant surface 1mm below the alveolar crest after the superimposition of the Cone Beam C.T scans as the difference between the former and new horizontal distance between the buccal and the palatal plate of bone
6 months
Patient satisfaction: VAS
Time Frame: 9 months
Patient satisfaction will be evaluated using a questionnaire which is based on a visual analog scale (VAS). A horizontal VAS bar, 100 mm long, with the right anchor labeled "much less than natural teeth" which is marked by zero and the left anchor labeled "much more" which is marked by 10 will be used. Five questions will be formulated to record the patients' satisfaction in terms of functionality and from an esthetic point of view. Participants will look in a mirror and also be viewed a photograph before recording their answers on the horizontal calibrated line.
9 months

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Chair: Amr F Zahran, Professor, Professor in Department of Oral Medicine and Periodontology

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)

February 22, 2019

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

September 24, 2018

First Submitted That Met QC Criteria

September 24, 2018

First Posted (Actual)

September 25, 2018

Study Record Updates

Last Update Posted (Actual)

February 18, 2020

Last Update Submitted That Met QC Criteria

February 17, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • CairoU12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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