Radiographic and Clinical Evaluation In Bar (implant)

May 7, 2024 updated by: Reem Abd El Moatty Abd El Monem, Minia University

Marginal Bone Loss and Soft Tissue Health Around Implants in Selective Laser Melted Versus Milled Cobalt Chromium Bar Retained Mandibular Overdenture:(Randomized Controlled Trial)

the aim of this study was to assess the marginal bone loss and soft tissue outcomes of milled and selective laser melted cobalt chromium bar retaining implant mandibular overdenture. Materials and method: twenty completely edentulous patients received new conventional complete dentures. Two implants were placed at mandibular canine areas, patients were randomly allocated into two equal groups: milled co-cr bar group and selective laser melted bar group. Marginal bone loss, modified plaque index (mPI), probing depth (PD) and modified gingival index (mGI) were evaluated at base line, 6 and 12 months follow up visits.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Materials and method: twenty completely edentulous patients received new conventional complete dentures. Two implants were placed at mandibular canine areas, patients were randomly allocated into two equal groups: milled co-cr bar group and selective laser melted bar group. Marginal bone loss, modified plaque index (mPI), probing depth (PD) and modified gingival index (mGI) were evaluated at base line, 6 and 12 months follow up visits.

Study Type

Interventional

Enrollment (Actual)

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 Locations

  • Egypt
    • Minia
      • Minya, Minia, Egypt, 61511
        • Minia 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:

  • completely edentulous patient.
  • age range (50-60) years old.
  • adequate bone volume in canine area bilaterally to receive implant of 3.7 mm diameter and 13mm length verified by CBCT for all patients.
  • sufficient inter arch space (13-14mm) to accommodate bar construction
  • normal maxillo-mandibular relation-ship
  • (Angel's class I)
  • proper oral hygiene

Exclusion Criteria:

  • patients with metabolic or systemic disease that may affect osseointegration.
  • history of radiation therapy.
  • history of bisphosphonate intake
  • heavy smoking and bad habits as bruxism.

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group 1: milled cobalt chromium bar
10 completely edentulous patients received two implants at canine region bilaterally (3.7mm diameter- 13mm length), within two weeks after surgery (following early loading protocol), an open tray impression technique was made for bar construction which was designed according to randomization patient enrollment
Other: bar retained implant overdenture
use of bar attachment in completely edentulous patient
Other Names:
  • bar attachment implant mandibular overdenture
Experimental: group 2: Selective laser melted cobalt chromium bar
10 completely edentulous patients received two implants at canine region bilaterally (3.7mm diameter- 13mm length), within two weeks after surgery (following early loading protocol), an open tray impression technique was made for bar construction which was designed according to randomization patient enrollment
Other: bar retained implant overdenture
use of bar attachment in completely edentulous patient
Other Names:
  • bar attachment implant mandibular overdenture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Evaluation (Vertical Marginal bone loss in millimeters)
Time Frame: at 6 and 12 months
using periapical x-ray with parallel long cone technique from implant shoulder till bony crest
at 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing depth in millimeters.
Time Frame: at 0,6 and 12 months
using sensitive pressure plastic probe in four sites mesial, distal, buccal and lingual
at 0,6 and 12 months
modified Plaque Index.
Time Frame: at 0,6 and 12 months follow up
using Mombelli charting scale at four aspects (mesial, distal, buccal and lingual)
at 0,6 and 12 months follow up
modified Gingival Index
Time Frame: at base line, 6 and 12 months
using Apsi charting scale at four sites (mesial, distal, buccal and lingual)
at base line, 6 and 12 months

Collaborators and Investigators

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

Sponsor

Minia University

Investigators

  • Study Chair: Eman A Asfahani, PHD, Minia university
  • Study Chair: Hussein A Elhady, PHD, Minia 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)

November 15, 2022

Primary Completion (Actual)

December 27, 2023

Study Completion (Actual)

January 5, 2024

Study Registration Dates

First Submitted

April 30, 2024

First Submitted That Met QC Criteria

May 2, 2024

First Posted (Actual)

May 6, 2024

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 636
  • Iman Adel Asfahani (Other Identifier: Minia university)
  • Hussein Abd Elhady (Other Identifier: Minia UNiversity)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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