Smart Box With OT Equator Attachment in Retaining Implant-assisted Overdenture for the Atrophic Maxilla.

April 23, 2022 updated by: Hams Hamed Abdelrahman

Smart Box Accompanied With OT Equator Attachment in Retaining Immediately Loaded Inclined Implant Assisted Overdenture for Atrophic Maxilla

The aim of the present study is to clinically and radiographically evaluate the effect of the use of recently developed Smart Box accompanied with OT Equator attachment in retaining of the inclined implant assisted overdenture for atrophic maxilla and to compare the vertical bone changes around axial implants with OT Equator attachment and inclined implants with smart box attachment radiographically using CBCT

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

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
        • Alexandria Faculty of Dentistry

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

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male patients with comparable age (30- 65 years).
  • All patients should have retruded, posteriorly atrophic completely edentulous maxilla with sinus pneumatization leaving less than 7mm bone height posteriorly and a sufficient amount of bone in the inter bicuspids region.
  • Opposing mandibular dentate arch including bilateral posterior teeth.
  • All patients should have an adequate zone of keratinized mucosa.
  • All patients should be free from any intra-oral or systemic diseases that would otherwise affect the osseointegration of dental implants.
  • All patients should be well motivated, cooperative, and with adequate manual dexterity necessary to place and remove removable implant prosthesis to provide adequate oral hygiene around the endosseous implants.

Exclusion Criteria:

  • Patients with flabby maxillary ridges.
  • Patients who are unwilling to accept implant overdentures as a treatment modality.
  • Patients with temporomandibular and neuromuscular disorders.

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
Experimental: Implant assisted maxillary overdenture
Horseshoe Maxillary Complete overdenture construction (Stabilizing and connecting the Smart Box housing)
Other: Implant assisted maxillary overdenture
For each patient, an implant assisted maxillary overdenture will be fabricated using a minimally invasive flapless surgical technique with OT-Equator and Smart Box attachment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in peri-implant probing depth
Time Frame: Baseline, 3 months, 6 months, 9 months
The peri-implant sulcus depth will be measured using a graduated plastic periodontal probe.
Baseline, 3 months, 6 months, 9 months
Change in Clinical Attachment level
Time Frame: Baseline, 3 months, 6 months, 9 months
It is the distance from the junction implant/abutment to the most apically probable portion, in millimeters
Baseline, 3 months, 6 months, 9 months
Change in Implant Stability
Time Frame: at baseline and 9 months
The Osstell unit records a numeric value of 1-100 which is referred to as the implant stability quotient (ISQ)
at baseline and 9 months
Change in alveolar bone level
Time Frame: at baseline and 9 months
The level of alveolar bone around each abutment will be evaluated using CBCT.
at baseline and 9 months

Collaborators and Investigators

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

Sponsor

Hams Hamed Abdelrahman

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)

March 1, 2018

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

April 23, 2022

First Submitted That Met QC Criteria

April 23, 2022

First Posted (Actual)

April 29, 2022

Study Record Updates

Last Update Posted (Actual)

April 29, 2022

Last Update Submitted That Met QC Criteria

April 23, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Overdenture_2022

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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