Immediate vs Delayed Loading of Two Implants Supporting a Mandibular Over Denture

December 1, 2014 updated by: Gian Schincaglia, UConn Health

Immediate vs Delayed Loading of Two Implants Supporting a Locator Retained Mandibular Overdenture - A Randomized Controlled Study

Edentulous patients have to wait after extractions and again after surgical implant placement for healing to occur before the implants can be restored and patients can go back to normal function. This delay in loading of implants can be handicapping for the patient, esthetically and functionally. Hence this project was undertaken with the purpose of reducing this wait period and achieving early rehabilitation in these patients. The aim of the project is to compare immediate loading versus delayed loading of implant supported mandibular dentures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

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

  • United States
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • University of Connecticut Health Center

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females at least >=21y of age
  • Provision of informed consent
  • Totally edentulous arch requiring or wearing mandibular complete denture
  • Tooth in implant sites must have been extracted at least 4 months before the implant placement.
  • Adequate amount of bone support to insert a 8mm in length and 4mm in diameter implant without encroaching on vital structures. The amount of bone available should be such that after implant placement there should be minimum of 1mm lingual and buccal bone
  • Implant insertion torque >=20Ncm
  • No need for bone augmentation procedures

Exclusion Criteria:

  • Conditions or circumstances as evaluated by the investigator, which would prevent completion of study participation.
  • Conditions requiring chronic routine use of antibiotics or requiring prolonged use of steroids.
  • History of leukocyte dysfunction or deficiencies, bleeding disorders, neoplastic disease requiring radiation or chemotherapy, metabolic bone disorder, uncontrolled endocrine disorders, HIV infection
  • Use of investigational drugs or devices within 30 days of study period,
  • Alcoholism or drug abuse and heavy smokers > 10 cigarettes a day.

  • Local factors such as

    • untreated periodontitis,
    • erosive lichen planus,
    • local irradiation history,
    • osseous lesion,
    • unhealed extraction socket,
    • intraoral infection,
    • lack of primary stability
    • inadequate oral hygiene
  • Simultaneous participation in another clinical study

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate implant loading
The test group had implant immediately loaded by means of a implant supported mandibular denture connected with locator abutment.
Procedure: dental implant placement
Active Comparator: Delayed implant loading group
The control group had implant loaded after 3 months of submerged healing by means of a implant supported mandibular denture connected with locator abutment.
Procedure: dental implant placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Radiographic bone level change around the implants
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Implant survival
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

UConn Health

Collaborators

Dentsply Astra tech

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

July 1, 2010

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

September 19, 2013

First Submitted That Met QC Criteria

September 23, 2013

First Posted (Estimate)

September 24, 2013

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IE-10-305-3

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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