Vertical Versus Inclined Implant to Retain Locator Maxillary Overdenture

May 4, 2023 updated by: Mansoura University

Vertical Implant Versus Inclined Implant to Retain Locator Maxillary Overdenture : One Year Randomized Controlled Clinical Trial

Objectives: evaluate the success rate, prosthetic maintenance , clinical and radiologic results of vertical implants with straight abutments versus inclined implants with angled abutments to retain locator maxillary overdentures. There were two groups : 1) The control group 2) The study group

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

the aim of the present investigation was to evaluate the success rate, prosthetic maintenance , clinical and radiologic results of vertical implants with straight abutments versus inclined implants with angled abutments to retain locator maxillary overdentures.

Materials and Methods conducted on 12 patients (6 males and 6 females) aged 58 to 68 years with completely edentulous maxillary ridges opposing implant-retained mandibular overdentures. Patients admit to the prosthodontic department, Faculty of Dentistry, Mansoura University for oral rehabilitation by implant-supported maxillary prostheses. Patients were allocated into one of two treatment groups: 1) The control group ; included 6 patients (3 males and 3 females) who will receive 4 vertical implants with straight trans mucosal abutments retaining locator maxillary overdenture 2) The study group; include 6 patients (3 males and 3 females) who will receive 4 inclined implants with angled trans mucosal abutments for retaining locator maxillary overdenture. Randomization and allocation of patients into treatment groups was made by dental personnel who is blind to treatment groups.

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
      • Mansoura, Egypt, 35516
        • Mansoura 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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Unable to wear the upper denture
  2. Radiographic diagnosis of bone loss

Exclusion Criteria:

  1. Neuromuscular diseases
  2. Insulin dependent diabetes

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: posterior vertical implants
the anterior implants were inserted in the canine/lateral incisor area bilaterally to each other's following the contour of the alveolar bone of the premaxilla. The posterior implants were inserted vertically just anterior to the maxillary sinus (in the area of second premolars) .
Procedure: implants
Four implants in the maxilla with locator attachments
Active Comparator: posterior inclined implants
The anterior implants were inserted in the canine/lateral incisor area bilaterally to each other's and will be inclined 15o labially following the contour of the alveolar bone of the premaxilla. The posterior implants were inserted just anterior to the maxillary sinus (in the area of second premolars) and inclined 15o distally .
Procedure: implants
Four implants in the maxilla with locator attachments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
plaque index
Time Frame: 12 months
measure plaque around each implant using Mombelli indices
12 months
pocket depth
Time Frame: 12 months
dental probe used to measure the depth of formed pocket around each implant
12 months
implant stability
Time Frame: 12 months
stability of each implant measured using Osstell® device
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic outcome
Time Frame: 12 months
measuring bone resorption using the long-cone standardized periapical radiography
12 months

Collaborators and Investigators

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

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Marwa Aboelez, Phd, Mansoura University
  • Study Chair: Mostafa Elsyad, Phd, Mansoura University

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)

January 15, 2022

Primary Completion (Actual)

March 25, 2023

Study Completion (Actual)

April 2, 2023

Study Registration Dates

First Submitted

April 12, 2023

First Submitted That Met QC Criteria

April 24, 2023

First Posted (Estimate)

May 4, 2023

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A26060722

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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