Ultra-wide Diameter Implants in Mandibular Molars (UWD)

July 24, 2023 updated by: Abdelrahman Elshahawy

Evaluation of Immediately Placed Ultra-wide Diameter Implant Placed in Mandibular Molars

The goal of this [clinical trial] is to [To evaluate both the clinical and radiographical outcome on osteointegration and peri-implant bone density when using ultra wide diameter implant placed immediately in molar extraction socket]

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

the aim of this study is to evaluate the clinical and radiographical outcomes on osseointegration and peri-implant bone density when using 12 ultrawide diameter dental implants placed immediately in 12 patients after atraumatic extraction of non-restorable mandibular molars without raising a flap or using bone grafts.

Study Type

Interventional

Enrollment (Actual)

12

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
      • Alexandria, Egypt, 20200
        • Alexandria 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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Adult patients ranging from 20-40 years.

  • Adequate bone beyond teeth apices without jeopardizing any anatomical structure.
  • Non-restorable mandibular molar teeth.
  • Available bone with adequate width and buccolingual dimensions.
  • Peri-implant bone defect should be 2mm or lesser.

Exclusion Criteria:

  • Smokers.
  • Medically compromised patients like uncontrolled diabetes and coagulation disorders.
  • Tooth with periapical pathosis or bony defects.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: non-restorable mandibular molar teeth
patients with non restorable mandibular molar teeth without any periapical pathosis to be extracted and implanted immediately using ultrawide diameter dental implants
Procedure: Immediate implant placement of Ultrawide diameter dental implants
immediate placement of ultrawide diameter dental implants in a fresh extraction socket of mandibular molar teeth
Other Names:
  • Ultrawide diameter dental implants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the mean value of implant stability
Time Frame: up to 6months
The implant stability was measured by implant stability meter (Osstell™) immediately postoperative and at 6 months.
up to 6months
the mean value of peri-implant bone density
Time Frame: up to 9 months
Radiographic evaluation of the bone density around each implant was done using OnDemand3D™.
up to 9 months
the mean value of Marginal bone loss
Time Frame: up to 9months
marginal bone levels were calculated from the reconstructed corrected sagittal views by drawing a line parallel to the implant serration extending from the crestal bone to the apical end of the implant. Average readings of the two sides at each interval were calculated and tabulated for statistical analysis.
up to 9months
the mean of peri-implant probing depth
Time Frame: up to 9 months
Probing depth was assessed according to Gallagher and Silver Probing pocket depth refers to the distance between the gingival margin and the bottom of the pocket
up to 9 months

Collaborators and Investigators

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

Sponsor

Abdelrahman Elshahawy

Investigators

  • Study Director: Gaafar N Elhalawani, Alexandria 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)

May 20, 2021

Primary Completion (Actual)

January 12, 2022

Study Completion (Actual)

March 3, 2022

Study Registration Dates

First Submitted

July 17, 2023

First Submitted That Met QC Criteria

July 24, 2023

First Posted (Actual)

August 2, 2023

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

July 24, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0210-01/2021

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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