Immediate Versus Delayed Loading for Implants Retaining Mandibular Complete Overdenture

December 11, 2022 updated by: Hams Hamed Abdelrahman

Immediate Versus Delayed Loading for Immediately Inserted Implants Retaining Mandibular Complete Overdenture

The aim of this study will be to compare the amount of marginal bone height changes between immediate and delayed loading for immediately inserted implants used as abutments of mandibular overdenture.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

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
      • Cairo, Egypt
        • Ain Shams 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

51 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient having two standing mandibular canines with compromised prognosis (which indicted for extraction, without any preapical lesions nor acute infection) and have an adequate labial bone thickness.
  • Patient having opposing completely edenteolous maxilla.
  • Patients having normal maxilla-mandibular relationship and sufficient inter arch distance was insured by through tentative jaw relation record.
  • Patients with good oral hygiene.
  • Enough bone volume for implants in the interforaminal region (adequate bone quality and quantity)

Exclusion Criteria:

  • Mental disorder patients who are not capable of making a decision or narcotic drug addicts.
  • Patients with Tempro-Mandibular Joint disorders
  • Patients undergoing radiotherapy or chemotherapy
  • Patients with systemic diseases affecting bone metabolism
  • Uncooperative patients who have no understanding of the need of a regular follow-up.
  • Patient with pathological defects in the areas of implant insertion.
  • Vulnerable group as prisoners, mentally retarded patients.

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
Experimental: Immediate loading implants
Other: Immediate loading of the implants
Patients of this group will be rehabilitated by implant-retained mandibular overdenture with immediate loading of the implants as opposed to conventional maxillary complete dentures.
Active Comparator: Delayed loading implants
Other: Delayed loading of the implant
Patients of this group will be rehabilitated by implant retained mandibular overdenture with delayed loading of the implants (after 3 months) opposed by conventional maxillary complete dentures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in bone loss
Time Frame: at 3 months, 6 months, 9 months, 12 months
Every 3 months all patients were recalled for assessment of marginal bone loss. The assessment was done using digital periapical radiograph Ezsensor (Vatech intraoral radiographic sensor, Vatech, South Korea) and the technique of radiograph was paralleling technique using sensor holder (TROLLBYTE PLUS, TROLLDENTAL, UK) to ensure same position of cone through subsequent follow-up exposures
at 3 months, 6 months, 9 months, 12 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)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

November 10, 2022

First Submitted That Met QC Criteria

November 10, 2022

First Posted (Actual)

November 17, 2022

Study Record Updates

Last Update Posted (Estimate)

December 14, 2022

Last Update Submitted That Met QC Criteria

December 11, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • implant_86_2018

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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