Soft and Hard Tissues Evaluation Around Immediately Placed New Implant Design

July 21, 2021 updated by: Walid Elamrousy, Kafrelsheikh University

Soft and Hard Tissues Evaluation Around Immediately Placed New Implant Design: Randomised Clinical Study

patients were randomly divided into Maxi-Z plus dental implant group versus Maxi-Z implant group

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

after tooth extraction implants will be placed immediately and provisional restoration will be placed in both groups to detect the advantaged and drawbacks of newly designed Maxi-Z plus dental implant versus Maxi-Z dental implant

Study Type

Interventional

Enrollment (Actual)

50

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
    • Kafrelsheikh
      • Kafr Ash Shaykh, Kafrelsheikh, Egypt, 214312
        • Faculty of Dentistry, Kafrelsheikh 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 to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • good health
  • unrestorable, periodontal healthy teeth

Exclusion Criteria:

  • systemic disease
  • periodontal disease
  • presence of abscess

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Maxi-Z plus dental implant
platform switched dental implants
Procedure: platform switching
reduced implant abutment interface
Active Comparator: Maxi-Z dental implant
platform matched dental implants
Procedure: platform amtching
matched implant abutment interface

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant mobility using Periotest M
Time Frame: 12 months
Periotest M values range from (-8 to 0). high values represent loose implant, while osseointegrated implants showed low values
12 months
marginal bone level
Time Frame: 12 months
measured in mm using X-ray
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pink estheic score
Time Frame: 12 months
from 0-12. 0 means bad aesthetic of soft tissue. 12 means the ultimate aesthetics of soft tissue
12 months

Collaborators and Investigators

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

Sponsor

Kafrelsheikh 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 (Actual)

April 1, 2020

Primary Completion (Actual)

June 9, 2021

Study Completion (Actual)

June 15, 2021

Study Registration Dates

First Submitted

May 26, 2021

First Submitted That Met QC Criteria

May 26, 2021

First Posted (Actual)

May 28, 2021

Study Record Updates

Last Update Posted (Actual)

July 22, 2021

Last Update Submitted That Met QC Criteria

July 21, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • assmortada2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

after research results publishing will decide

IPD Sharing Time Frame

by the end of August 2021 for 6 months

IPD Sharing Access Criteria

open access

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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