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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Mohamed A Abd El Moneium, Ass.lecturer
  • Phone Number: 002 01224302609
  • Email: matef1989@gmail.com

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 22, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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