Evaluation of Short Implants' Success for Teeth Replacement in Atrophic Posterior Mandibular Ridge

May 30, 2020 updated by: fady michel tadros hanna, Alexandria University

Evaluation of Short Implants' Success for Teeth Replacement in Atrophic Posterior Mandibular Ridge (A Clinical Trial)

The aim of this study was to evaluate clinically and radiographically the splinted short implants' and single short implants' stability and bone condition before and after loading, in atrophic posterior mandibular alveolar ridges.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A prospective study was conducted on 16 Patients with missing posterior molars. Group A: 8 patients had 2 short implants placed in atrophic posterior mandibular alveolar ridge. Group B: 8 patients had a single short implant placed in atrophic posterior mandibular alveolar ridge.

Study Type

Interventional

Enrollment (Actual)

16

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, 21527
        • Faculty of Dentistry, 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

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Missing Posterior teeth, indicated for short implant placement.
  • Residual alveolar ridge at 6-8 mm height and at least 7mm width.
  • Healthy band of keratinized attached mucosa.
  • Good Oral hygiene.
  • Medically fit patient, free from relevant diseases.

Exclusion Criteria:

  • Medically compromised patients.
  • Imunnocompromised patients
  • Patients with Para-functional habits.
  • Smokers
  • Poor Oral hygiene.
  • Patient refuse to undergo the surgery.

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: Two short implants
DENTIUM superline implant fixture is characterized by sandblasted with large grits and acid etched surface treatment (S.L.A). SLA surface allows good bone-implant contact with good clinical performance, maintaining crestal bone margin. Short Implants of 7.0 mm length and 4.5 mm diameter are to be used. The Short Implants are characterized by 1.5mm supra-bony smooth collar, and 5.5mm infra-bony surface treated double threaded titanium.
Other: Double short implant
Patients receives 2 short implants to restore missing posterior teeth, loaded with splinted screw retained crowns.
Active Comparator: Single short implant
DENTIUM superline implant fixture is characterized by sandblasted with large grits and acid etched surface treatment (S.L.A). SLA surface allows good bone-implant contact with good clinical performance, maintaining crestal bone margin. Short Implants of 7.0 mm length and 4.5 mm diameter are to be used. The Short Implants are characterized by 1.5mm supra-bony smooth collar, and 5.5mm infra-bony surface treated double threaded titanium.
Other: Single short implant
Patients receives single short implants, loaded with single screw retained crowns.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Stability
Time Frame: Immediately after the operation
Implant stability was measured using Implant Stability Quotient (ISQ), a scale from 1 to 100. The ISQ scale has a non-linear correlation to micro-mobility. High stability means >70 ISQ, between 60-69 is medium stability and < 60 ISQ is considered as low stability.
Immediately after the operation
Implant Stability
Time Frame: 3 months
Implant stability was measured using Implant Stability Quotient (ISQ), a scale from 1 to 100. The ISQ scale has a non-linear correlation to micro-mobility. High stability means >70 ISQ, between 60-69 is medium stability and < 60 ISQ is considered as low stability.
3 months
Implant Stability
Time Frame: 6 months
Implant stability was measured using Implant Stability Quotient (ISQ), a scale from 1 to 100. The ISQ scale has a non-linear correlation to micro-mobility. High stability means >70 ISQ, between 60-69 is medium stability and < 60 ISQ is considered as low stability.
6 months

Collaborators and Investigators

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

Sponsor

Alexandria 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)

April 14, 2019

Primary Completion (Actual)

January 20, 2020

Study Completion (Actual)

February 20, 2020

Study Registration Dates

First Submitted

May 30, 2020

First Submitted That Met QC Criteria

May 30, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

June 4, 2020

Last Update Submitted That Met QC Criteria

May 30, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IORG 0008839

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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